chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hurts from his arm all the way through his neck and jaw and threw the rest of his body; hurts from his arm all the way through his neck and jaw and threw the rest of his body; hurts from his arm all the way through his neck and jaw and threw the rest of his body; This is a spontaneous report from a non contactable consumer. An adult male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hurts from his arm all the way through his neck and jaw and threw the rest of his body on 07Jan2021 with outcome of recovering. He said it was worse than any flu he has ever felt. No therapeutic measures were taken as a result of the event. The event was considered as non serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
5 months after 2nd dose of Moderna developed limited loss of vision in left eye. Saw Opthalmologist and was referred to retina specialist. Left eye found to have acute vitreous hemorrhage. Partial posterior vitreous detachment. Still 8 months later experiencing floaters and less visibility in left eye.
Painful, red, swollen injection site on the left deltoid. Red puffy rash around both eyes. Nausea and vomiting. Patient is taking diphenhydramine. Symptoms started approx. 24 hours post injection. Treatment started approx. 48 hours post injection.
Red and swollen fingers on both hands; they were sore because they were swollen. My arm was sore at the injection site. Muscle soreness when I raised my arm above my shoulder. If I was going to examine someone for a rotator cuff injury - with the arm above that is where the soreness was. Nurse practitioner took picture of my hand that first day and the next day Dr looked at it. I had these symptoms for two weeks. My fingers are still kind of sore now. I had to try a few things to get the ring off my finger but otherwise no treatment.
p/vax pt sore throat; nasal congestion; generalized body malaise; aches & pains; rash on flank
Information has been received from a special education teacher, concerning a male student between 6 to 7 years old, who on an unspecified date received a dose of MMR II (Lot number not available) and on an unspecified date was hospitalized (hospital demographics not available) after he received MMR II. The teacher reported that the student was now in special education school (no further details available). At the time of reporting, the patient was not recovered. This is one of several reports from the same source. This is an amended report. Labeling was changed from Yes to No for the AE term of Adverse Event. Additional information is not expected.
The vaccine ran down from the injection site to the elbow; A spontaneous report was received from a healthcare facility staff member concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, vaccine ran down from the injection site to the elbow.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. During vaccine administration, the syringe that comes with the vaccine popped off and the vaccine ran down from the injection site to the elbow. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, vaccine ran down from the injection site to the elbow, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of incomplete dose administered. This event occurred the same day of vaccine administration. The reporter did not provide the causality assessment for the events. The event is more of a mechanical error and was assessed as not related to Moderna COVID-19 Vaccine.
Breakthrough case admission after 3 vaccines Pfizer 1/26/21 Lot# EL9246;  PFizer 2/16/21 Lot# En6200;  Pfizer 10/3/21 Lot# FE3592
missed this vaccine when administered Quadracel/missed the ACTHIB portion not in this vaccine with no reported adverse event; Initial information received on 02-Dec-2022 regarding an unsolicited valid  non-serious case via other health professional.  This case involves a 8-month-old female patient who missed this vaccine when administered Quadracel/missed the ACTHIB portion not in this vaccine with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine (Hepatitis B Vaccine); and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13).  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, expiry date, batch lot number: unknown) via unknown route in unknown administration site for immunization. Information on batch number and expiry date was requested.  On 16-Nov-2022 the patient had a non-serious event of missed this vaccine when administered Quadracel/missed the ACTHIB portion not in this vaccine with no reported adverse event (product preparation issue) (unknown latency) following the administration of HIB (PRP/T) vaccine.  Action taken with haemophilus type B (HIB) vaccine (ACT-HIB) was not applicable.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2022SA496172:01390021
Pt presented with a rash on her left arm on 10/30/20 at the pharmacy. Rash was hot to the touch and hurt. I advised the patient to try diphenhydramine OTC to rule out an allergic reaction. 4 hours later I called the pt and her arm was still sore and the rash had not improved after taking diphenhydramine. I advised her to follow up with her dr and they prescribed doxycycline.
Initial report received from a health care professional on 02 August 2013. A baby was exposed in utero to ADACEL, VALTREX, and Influenza vaccines. The baby was diagnosed with polydactyly. The outcome was not reported. This is linked to mother case 2012-09844. Documents held by sender: None.
Information has been received from a licensed practical nurse concerning a 4 month old male with no pertinent medical history or drug allergies who on 01-MAY-2008 was vaccinated PO with a first and second dose of ROTATEQ (lot# 657987/1394U, 657987/1394U) on the same day.  Concomitant vaccinations administered on that same day included a dose of ACTHIB, a dose of PEDIARIX and a dose of PREVNAR.  On 02-MAY-2008 the patient experienced constipation.  The patient's mother contacted the office at the time of the event and the patient was scheduled to come into the office on 05-MAY-2008 to see the physician.  No labs or diagnostic studies were performed.  The outcome was unknown.  There was no product quality complaint.  No further information is available.  Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to multiple patients of an unknown age and gender. No information regarding the patients' concurrent conditions and medical history was provided. On an unknown dates, multiple patients were vaccinated with an unspecified number of doses of improperly stored ROTATEQ lot# K021484, expiration date: 13-MAY-2016 or lot# K010224, expiration date: 25-FEB-2016 (orally; dose was not reported). The patients' concomitant therapy was not reported. There were no adverse effects reported. Product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from an occupational therapist concerning an approx 3 year old male pt with no allergies and a history of neurological disorders noted at birth with low muscle tone, poor upper extremity movement, some seizure movement noted but an EEG was unclear, ocular flutter and jerking movements, who was vaccinated with varicella virus vaccine live. Other vaccine therapy included measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), hep B virus vaccine rHBsAg (yeast) (manf unk), poliovirus vaccine and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. The reporter noted that since the previously reported neurological disorders as an infant, he has had frequent sinus infections with lung and chest congestion, ataxic gait with poor balance, poor tongue movement and pain in his hands. The reported mentioned that the pt did not walk until he was three years old. Recently (approx 2005) he was diagnosed with autosomal dominant movement disorder. He is now in kindergarten. The pt has been treated with physical and occupational therapies. The reporter also mentioned that the pt's mother has the same symptoms and diagnosis with similar body movements. It was noted that the reporter questioned "if symptoms are related to vaccinations received or lack of vaccinations that he should have received thus far. Unspecified lab tests were performed. There was no product quality complaint reported. The reporter considered the events to be other important medical events. Sinus infections, lung and chest congestion, ataxic gait, poor balance, poor tongue movement, pains in hands and Autosomal dominant movement disorder were considered to be disabling by the reporter. Additional information has been requested.
First unusual symptom the day after vaccine - felt as though we were experiencing an earthquake.  Unsteady balance since then.  I had aches common with flu shots, which are now (3/9) gone - these are not a problem.  Yesterday my apple watch said my heart beat was below 40 bpm for ten minutes a few times.  I tend to have a low heart rate so not a major surprise.  But last night when I got up, I lost balance and fell, hitting my head on a chest.  No major damage.  But feeling of dizziness is still a little present.
Highest Fever 102.4, Body Aches, Headaches Still occuring after 24 hours
Vaccine given 9/10, 9/10 pt noted to have pink area on deltoid. Pt noted to have pink faint 3.5 x 2 inches on deltoid surrounding injection site. Varicella site not affected.
Edema Nausea Dizziness Sweating Injection Site Reaction It was reported that a 41-year-old woman received a Fluzone SV '00-'01 vaccination on 23-Oct-2000. Reportedly, fifteen minutes after the vaccination the patient experienced redness and swelling at the injection site, dizziness, nausea and cool and clammy skin. The patient laid down for twenty minutes and the symptoms subsided. Further information is being requested. From additional correspondence received on 7-Feb-2001, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information was also provided. No further information is expected for this case. Case is closed.
Red, swollen area on left leg. Leg soreness, 5" diameter area of redness. No fever, Patients parents used a cold pack to help relieve pain.
pt. recieved vaccine greater than 12 hours after being drawn up. MD contacted pt. no adverse event. pt. wanted antibody test which was ordered.
Blurry Vision; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 63-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via unspecified route of administration in the right arm at 12:45 on 23Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and GERD. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lansoprazole (PREVACID), ursodeoxycholic acid (URSO), Salmeterol (SEREVENT), beclomethasone dipropionate (QVAR), Diltiazem hydrochloride (DIL). The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN), via unspecified route of administration at 14:30 in right arm on 03Mar2021 (at the age of 63-years-old) as a single dose for Covid-19 immunisation. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not be tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 14:45, patient experienced headache, chills, blurry vision. The adverse events did not result in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcome of the event headache, chills, blurry vision was recovered at the time of this report.   No follow-up attempts are needed; No further information is expected.
(1 AM) About 36 hrs after vacine pt reports shaking/tremors w/ slight fever (100 degrees). Shaking was "intense" w/ muscle stiffness. About 1 hr later shaking stopped but fever of 102.9 degrees - was able to go back to sleep but awoke tired and weak w/ temp 100.2 degrees. Temp was back to normal by 9 AM.
she noticed she was scratching under her breasts and around on her back. Her son and she checked. There was no apparent rash. No other symptoms. It was 3 AM and she just woke up scratching the area again.; This is a spontaneous report from a contactable consumer, the patient. A 71-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 left arm on 03Mar2021 (at the age of 71-year-old) at 15:15 as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), osteoarthritis, high cholesterol, thyroid cancer and removal, gallbladder removal, hysterectomy and nickel allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), fenofibrate (MANUFACTURER UNKNOWN), levothyroxine sodium (LEVOXYL) and pramipexole (MANUFACTURER UNKNOWN); all taken for an unknown indication, from an unknown date and unknown if ongoing. The patient previously received diflucan (MANUFACTURER UNKNOWN) and experienced drug allergy. On 03Mar2021 at 20:00, about 5 or 6 hours after the vaccination, the patient noticed that she was scratching under her breasts and around on her back. She and her son checked that there was no apparent rash and no other symptoms. It was 03:00 and she just woke up scratching the area again (pruritus). It was burning so she applied a cold wet cloth and it settled quickly. The patient had messaged her physician with this information also and she was not concerned at all. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pruritus was recovered on 04Mar2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Upon waking up the following morning, I experienced leg cramps and nausea.  As the day progressed I had an overall achiness and fatigue, often had chills, and had periodic leg cramps and head aches.   This continued into the early morning the next day, when I broke out into sweats in my sleep, and then the symptoms passed.  Total time from onset to resolution was approximately 18 hours.
Assessment and Plan:   92-year-old female presented in the setting of UTI and positive blood cultures admitted for IV ceftriaxone.  Repeat cultures from 6/28 and 6/29 showing preliminary no growth, repeat blood cultures from 7/1 in process.  Had a smooth night into 7/2/2023 and was discharged in satisfactory condition to complete a course of p.o. cefadroxil.    COVID swab was checked day of discharge (per family request; apparently patient had been exposed to COVID prior to admission) and resulted positive.  Given that there were no measured hypoxemia, no new recommendations at this point other than to monitor symptoms and abide by home isolation and routine mask mask usage x5 days.    See also discharge summary that was pre-completed yesterday, reproduced below in italics.   ...she has a PMH of HTN, Afib on AC, diverticulosis, HLD, and stress urinary incontinence. She was recently seen in ED on 6/28 for left flank pain and UTI, and was discharged with cefadroxil. She was called back to the ED due to BCx positive for GNR and started on CTX. Blood and urine cultures grew E.coli (resistant to bactrim, otherwise pansusceptible). She was discharged on cefadroxil, plan for total of 2 week course.    Noted to have thrombocytopenia down to 80s. Likely in setting of infection. Improving at discharge, ordered for repeat labs as outpatient.        _________________ PPE Worn:   Mask: Isolation Eye Protection: no Patient Masked: no Hand Hygiene: yes        DO Hospitalist HBS      Note Details  Author (D.O.) File Time 7/2/2023 12:39 PM Author Type PHYSICIAN (D.O.) Status Addendum Last Editor (D.O.) Specialty Hospital Medicine Admit Date 6/29/2023  ED to Hosp-Admission (Discharged) on 6/29/2023  ED to Hosp-Admission (Discharged) on 6/29/2023   Revision History   Detailed Report  Note shared with patient Care Timeline  06/29   Admitted from ED 1817 07/02   Discharged 1352
Experiencing a sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Apr2021 (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: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Experiencing a sore throat".  Additional information: The caller (withheld) said that he received the 1st dose of the vaccine on 18Apr2021, and he is scheduled to get the 2nd shot today, but he is experiencing a sore throat and he would like to know if he can still get the scheduled shot today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
approx 4 hrs p/recvd vax pt devel persistant crying for 5 days; cried almost all the time was awake; no fever cry not high pitched; no treatment given;
I received my injection in my left arm on 10/08/15.  That evening, I experienced malaise and a low grade fever of 99.4.  When I woke up the next morning, I had pain under my left arm, in my neck, and in the left clavicular area.  I noticed several pea sized swollen lymph nodes in the clavicular area and neck but I could not palpate any in the left armpit area.  I could hardly raise my left arm and it was even more painful to turn my neck.  I realized that last year these symptoms occurred but it was about a week after my injection and it was not as severe.  The symptoms lasted about 2 weeks. Last year I got my injection on the R) arm and the symptoms were on the right.  I did get the flu in January of this year.
Chills, fever, aching all over (including arm given in), extreme tiredness, nausea
Parents reported rapidly rising temperature. Parents reported that they stopped taking temperature at 102F and at ER it was found to be 103.9F
Woke with heart attack like symptoms out of a deep sleep. Throbbing, pressure and pain on my left side by shoulder blades, shoulder. Would not go away for 10 min. then got up to use the bathroom and felt better, googled and said could be this, so leaned forward and was ok. Slept. the next night had same wake up, but had taken advil. was not as intense, leaned forward and was fine again. Saw a cardiologist on Monday and had ultrasound, EKG and bloodwork and was fine. After 3 days of advil, I guess it was temporary.
rash on hands--had this happen once last summer after working in garden.  She did work in garden this morning but didn't know if it was that or covid vaccine
MODERNA BUD 1/7/23, ADMINISTERED 1/12/23 - MODERNA ANAYLSIS FOUND LOT STILL ACTIVE AGAINST COVID-19 ON DATE GIVEN
Cellulitis at site. Red, swollen, well marked streaks of redness around site down to elbow. Warm to touch and painful. Left arm.
On 03/21, pt presented "crankyness," started screaming all night and vomited one time. He would not eat or drink. On 03/22 went to ER and tests were performed with questionable bronchitis. Given Z pack. Child was still running a fever of 100.8 deg. F. Well or acting normal until 03/27.
Patient was experiencing her throat feeling funny and she stated she feared her throat would close. Started about 5-10 minutes after administration.  We gave the patient a water and sat and talked to her for the next 25 minutes.  Nothing else occurred and the patient was fine to leave.
PATIENT HOSPITALIZED ON 4/18. ON 4/19- CT SCAN WITH CONTRAST- SMALL PULMONARY EMBOLISM RT LOWER LOBE
Developed fever 4 hours after pnuemoccoccal 23 valent vaccine swelling left leg at injection site with tenderness also had URI srs. when seen on 2/11/05.
After receiving the shot arm became very sore in afternoon.  Arm better but continues to be sore.  Hurts when sleep on same side.  Hurts in joint.
ADMINISTRATION ERROR: NURSE NOTIFIED PROPER CHANNELS AND PT IS RETURNING NEXT WEEK FOR ADULT DOSE.
This spontaneous report was received from a registered pharmacist concerning a female patient in her 70's who on an unknown date was vaccinated with a dose of PNEUMOVAX23, subcutaneous (dose not provided) (lot # 0709AE, expiration date on 04-JAN-2014). Secondary suspect therapy included flu vaccine (manufacturer unknown but AFLURIA could not ruled out) (dose, route and lot # not provided) administered on the same date on the same arm with PNEUMOVAX23. On an unknown date, the patient came down with fever and rash around injection site with color of scarlet red. No treatment was given for the events. The patient spoke to pharmacist. At the time of the report, the outcome of the events was unknown. A lot check investigation was initiated. This is one of several reports received from the same source. Additional information has been requested.
Local hypersensitivity reaction an right arm with pruritis, swelling, redness treated with Benadryl and local ice.