chrisvoncsefalvay/vaers-outcomes huggingface dataset:
C/O headache increased fatigue, weakness. Developed Idiopathic thrombocytopenic purpura (ITP).
Right hand falls asleep multiple times per day....fairly certain not from sleeping on it or otherwise. Numb, tingly sensations in right hand and wrist area.
Closed fracture of left hip. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
patient received improperly stored vaccine on 4/24/2019; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided.  On 24-APR-2019, the patient was vaccinated with improperly stored one dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S002459, expiry date 15-MAY-2020; injection site and route of administration were not reported) for prophylaxis. The vaccine was exposed to the temperature of 52.5 degrees Fahrenheit (F) for 4 hours and 40 minutes. There was no previous temperature excursion. Digital data logger was involved.
Narrative: patient tolerated the COVID 19 Vaccine for 6 hours for 6 hours after administration. took Emergen-C supplement ~ 5 hours after vaccine administration, developed lip swelling, no rash no sob, no swelling of the throat 1.5 hours after this supplement
On day of vaccine and day after had mild soreness and very mild swelling at injection site Exactly one week later - Sunday Jan 24 AM - same area of arm had a rectangular red rash, mild, more pronounced around edges of area; about 1.5" wide and about 2" high; slightly swollen. Site was also itchy and warm. Symptoms the same on Monday Jan 25. On Tuesday Jan 26 redness is going away, slightly less rash in texture, and only occasional itchiness.
Moderna COVID- 19 Vaccine EUA: patient presents to clinic for follow-up one month after developing hives, shortness of breath and sweling of lips and tongue 36 hours after vaccination. Patient went to an emergency department and treated with steroids and antihistamines. Patient has a history of recurrent hives and lip swelling  managed with antihistamines.
During new employee health screening pt. was given TB skin test and influenza vaccine. Blood drawn; during blood draw pt experienced vasovagal response including seizure like movements. 911 called, pt declined ER visit, returned to work.
We gave Patient the Moderna booster and instead of half dose, we gave full dose (0.5 ml). We called the patient to let them know and they said they are feeling fine.
Patient states started having pain and swelling at injection site.  The size of a tangerine, hard and raised with a small rash which has continued to grow to about 4 to 5 inches.  Rash is itchy and hot. No fever .
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 08-JUN-2012, the patient was administered with a dose of VARIVAX (Lot # 1909AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Baby died at home early AM on 11/16/01. Autopsy results received state cause of death as pneumonia. There is an umbilical hernia; occasional posterior epicardial petechiae and pleural surfaces also have scattered petechiae on the visceral pleura and the parenchyma exudes slight to moderate amounts of blood and frothy fluid. The lungs show congestion, patchy interstitial and peribronchial acute and chronic inflammation with areas of edema bilaterally. The lungs had focal areas of pneumonia which demonstrated clusters of gram-positive cocci. Immunohistochemical staining of lung was positive for Streptococcus pneumoniae. There are scattered petechiae on the superior surface of the diaphragm. The liver and spleen are congested as are the kidneys. The brain has diffuse congestion, rare eosinophilic degeneration of neurons in the hippocampus and an infantile architecture. The adrenal has congestion and focal hemorrhage. Esophagus and stomach with mild chronic inflammation and scattered eosinophils. The thyroid has congestion.
PT REC'D COVID VACCINE  LL IM  07/05/22 APPROX. 5MIN AFTER VACCINE WAS ADMINISTERED PATIENT VOMITED A LARGE AMOUNT. PATIENT WAS NOT WORKED UP FROM THE VACCINE PER MOTHER OF CHILD, PT WAS CALM WHEN VOMITING EPISODE HAPPENED. PATIENT WAS EXAMINED BY ONE OF OUR PHYSICIANS AND DURING EXAM HAD 2 MORE VOMITING EPISODES. ONE EPISODE PT WAS FUSSY. VITALS  TAKEN & WERE STABLE, PHYSICAN WAS UNSURE IF HE FELT IT WAS TRULY VACCINE RELATED . PT IS SCHEDULED FOR HIS 2ND VACCINE 07/26/22. PROGRESS REPORT FROM MOM TODAY 07/08/22 STATES PT IS DOING WELL, BACK TO NORMAL  AFTER LEAVING CLINIC 07/05/22, NO OTHER VOMITING EPISODES OR OTHER REACTIONS WERE NOTED BY PARENT.
pt recv vax 22OCT96 & on 8FEB97 pt devel herpes zoster consisting of a vesicular, erythematous rash following the L4 dermatome on rt side;14FEB97 pt recovered from herpes zoster;
1/26/19-sore arm; 1/27/19-pt stated she "didn't feel well"; 1/28/19-fever 100.1 F, injection site and surrounding areas warm to touch; 1/29-1/30-area around injection site more warm and increased in size to 2x2 inches per pt; 1/31-pt saw Dr and was prescribed 10 days oral antibiotic and steroid cream.
pt devel a red, raised rash over trunk & arms 9 days p/flu vax;
Patient did not report until following day. Itching eyes/face 20 min after vaccines. No respiratory problems. Tongue "felt heavy" but no trouble swallowing same evening, resolved next day.
difficulty breathing; rash; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (Pfizer COVID-19 vaccine), via an unspecified route of administration on 25Mar2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient received the 1st dose of the Pfizer covid-19 vaccine yesterday (25Mar2021) and today (26Mar2021) she's having a bunch of symptoms. She's having difficulty breathing and having a rash. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report was received from a medical assistant and refers to a 9-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # N003703 with an expiration date of 29-OCT-2019 (dose, route of administration and anatomical location were not reported). On 04-AUG-2017, the administered vaccine underwent a temperature excursion of 48.79 degrees Fahrenheit for 38 minutes which was detected by a digital data logger. No previous temperature excursion was reported. On 09-AUG-2017, the patient passed out for an unspecified period of time following administration of GARDASIL 9. The patient was evaluated in a physician's office. No treatment was given for the event. The patient waited a little while then went home. The outcome of the event was considered as unknown. The causality assessment was not provided. Upon internal review, the event of "passed out" was considered to be medically significant. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA005827: US-009507513-1708USA005890: US-009507513-1708USA005891:
Skin rash and pruritis, warmth, redness at site of injection. Diphenhydramine.
Arm soreness at injection site, headache, light nausea, fatigue, fever that started the first night.  Severe muscle cramps/ spasms in upper back that started the second day around lunch and lasted about 5 hours.
Based upon history of ITP,  patient had CBC performed on 8/1 confirming normal platelet count.  Received vaccine on 8/10,  Repeat CBC on 8/19 with normal platelet count (272).  ON 8/29 developed symptoms suggestive of thrombocytopenia and repeat CBC on 8/30 confirmed platelet count of 5.
10MAY97 exam spotty erythematous rash on face, trunk;fever 103;face swollen;poor appetite;no other findings in hx on exam;DPH started by MD;
This spontaneous report as received from a healthcare worker refers to a 4 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information provided. Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date. Before use date reported was 12-May-2022. No treatment information provided.       This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up received: Patient information and vaccination details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent medical conditions, concomitant therapies, medical history and allergies were not provided. On 30-DEC-2016 the patient received a dose of VARIVAX (strength, dose, route, lot# and expiration date were unknown) and received a second dose of VARIVAX (strength, dose, route, lot# and expiration date were unknown) on 06-JAN-2017 for prophylaxis (drug use for unapproved schedule). No adverse effect reported.    Additional information has been requested.
The caller mentioned the patient's mother is pregnant; some patient's mother that somehow got some Prevnar 13 in her eye; some patient's mother that somehow got some Prevnar 13 in her eye; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient (pregnant) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPOSURE DURING PREGNANCY (intervention required), described as "The caller mentioned the patient's mother is pregnant"; ACCIDENTAL EXPOSURE TO PRODUCT (intervention required), EXPOSURE VIA EYE CONTACT (intervention required) and all described as "some patient's mother that somehow got some Prevnar 13 in her eye". Caller mentioned that "we hot some patient's mother that somehow got some Prevnar 13 in her eye. I was calling to see if there should be any extra concern besides flushing the eye out". The caller mentioned the patient's mother is pregnant.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
12pm: developed cough and runny nose, irritability 5/12/18, 6am: woke up with fever of 99.6; fever persisted until 7pm between 99.6-100.4 degrees Fahrenheit. Continued cough, runny nose, lack of appetite; at 3pm vomited 3 times. As of 5/14/18 irritability and lack of appetite persist.
Patient developed purple blisters on the wrist going up (on the same side of administered location) 3 days after first Shingrix administration. Purple spots started to fade within a course of 2 weeks after vaccine administration. This adverse event did not affect patient's health. Patient has been recommended to consult primary care provider to determine whether getting second dose of Shingrix is safe.
Patient stated the she developed a red rash 1 day following shingle vax. Patient did not go to ER or PCP but did contact PCP by phone and was prescribed BENADRYL 25 mg 4 x daily.
Subcutaneous route; Swollen arm; Redness, hot and a bump in the injection site; Redness, hot and a bump in the injection site; Redness, hot and a bump in the injection site; This case was reported by a other health professional via call center representative and described the occurrence of swelling arm in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) and (batch number 477z77, expiry date 7th February 2021) for prophylaxis.   On 21st February 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. In February 2020, less than a week after receiving Shingrix, the patient experienced swelling arm, injection site erythema, injection site warmth and injection site swelling. On 21st February 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the swelling arm, injection site erythema, injection site warmth, injection site swelling and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the swelling arm, injection site erythema, injection site warmth and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The reporter stated that the patient experienced swelling arm, injection site erythema, injection site warmth and injection site swelling after vaccination. The patient received the second dose of Shingrix by the subcutaneous route, which led to intramuscular formulation administered by other route. The reporter consented to follow up.
Patient reported chest tightness 6-8 minutes into their 15 minute monitoring after receiving their second dose of Pfizer vaccine at health department POD. EMS was onsite and began monitoring patient. Multiple set of vital signs were obtained within normal limits. 2 EKG strips obtained by EMS showed normal sinus rhythm. No medications given, symptoms resolved on their own and Patient refused EMS transport.
Headache, slight fever, moderate achiness, tiredness, nausea and lack of appetite,  back ache, very swollen and hot arm.
lost vision of half of right eye; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is the 1st of 2 reports.   A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 08Feb2021 at 10:40 (pending clarification) (at the age of 74years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 intramuscular (left arm) on 18Jan2021 10:00 (at the age of 74years) for Covid-19 immunization. Medical history included high pressure, high sugar, and liver disorder; all from an unknown date and unknown if ongoing; no known allergies. Concomitant medications included nadolol, lisinopril, and metformin; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021 at 11:00am, 20 minutes after getting the shot, the patient experienced "lost vision of half of right eye" that lasted a few minutes. There was no treatment received for the adverse event. The patient was tested for Covid post vaccination (nasal swab) on 02Mar2021 with negative result. The outcome of event was recovered with sequel (also reported as recovered with lasting effects).  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021291774 same reporter, drug and event, different patient.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 27-JUL-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot# and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered facial painful rash, swollen cheeks, blisters and small lesions that expanded to large lesions, pain and swelling of face and was diagnosed with shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), her symptoms resulted in physical limitations not presented prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of shingles was determined to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was considered to be disabling.
Information has been received from a RN pharmacist concerning a pt who was vaccinated with pneumococcal 23v polysaccharide vaccine. Concomitant therapy that day included influenza virus vaccine (unspecified). Subsequently the pt experienced cellulitis in the arm that the pneumococcal 23v polysaccharide vaccine was given. Unspecified medical attention was sought.
Patient received vaccine PPV23 on their right deltoid and within 2 minutes of vaccine patient stated they had a full body hot flash and started experiencing severe lower back muscle spasms. Hot flash and back spasms resolved within five minutes. Patient remained in office twenty minutes after the resolution of symptoms. Patient blood pressure was also elevated, and blood pressure came down some after 20 minutes of symptom resolution. Patient has been off blood pressure medication for two days.
I felt like i had to throw up.  Took off from work went home I was running fever  101.3 .  Took two Tylenol.  I felt my joint  hurt , my left arm was the sorest from any shot I ever had and is still very sore.  I went to bed slept 12 hours.  I still feel weak but no fever yet
Redness, arm soreness, swelling, warmness. Ibuprofen for treatment.
No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call  that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.
Patient reported blotchy red patch/circle on vaccinated arm that appeared approximately 8 days after vaccination.
In early October, noticed left ring finger became very swollen (approximately a size 10 ring size when normally a 6/7 ring size and painful to bend. By October 27, right hand?s middle finger was also swollen and painful to bend.  Returned to primary care physician 11/17 and same fingers were swollen and 4th toe on right foot. By 12/4, left ring finger, right pointer finger, right middle finger, right 4th toe and right knee are swollen and some pain in my left toes. Experienced asthma attack 11/15, first time in approximately 4 years since last attack.
Patient discharged after (3) day inpatient admission. Patient is a 53 y.o. male with pmhx relevant for Obesity (BMI 43.46), OSA (non-adherent with home CPAP), Depression, and GERD admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. He is vaccinated x2 with Pfizer. Symptoms started 12/7. Tested positive 12/13. Received dexamethasone from 12/13, Remdesivir from 12/13. Is discharged on home oxygen none at rest 4L with exertion. Due to continued supplemental oxygen requirements I have prescribed dexamethasone 3 more days to complete 7 day course. Patient is advised of quarantine guidelines and understands that earliest clearance date is 12/18. He was also informed of new diagnosis of prediabetes (HbA1c 6.0) and advised on lifestyle modifications, follow-up. He is enrolled with COVID at home monitoring program at discharge and wife is a nurse as well.
Temp 100.2, right arm swollen, red, warm - shoulder right should joint rare than muscle painful. Recommend client to call her MD since it was swelling in joint arms not sight of injection.
non-response in 6 out of 8 pts who completed series (3 doses) of Engerix-B;
5 days after the vaccine I developed shingles on my neck.  And had neck and arm pain, stiff neck, tingling numbness and itchiness around the bumps on my neck, warm feeling in the area and itchiness under my skins and pain like pins and needles in the area. Fatigue and chills.
Pt complained of feeling dizzy/hot/nauseous during observation. Patient was moved to a seat closer to a fan and given a cool cloth. BP was 180/110. EMS called and didn't arrive for 40 minutes.
Patient developed fine rash all over body as of 11-15-21 at 10:00 a.m.  Mom did use a new Scented lotion on child after his bath on 11-14-21 evening.  Unsure if rash is from lotion or vaccine.
CLIENT STATED HE HAD NOT RECEIVED A COVID VACCINE & REQUESTED JANSSEN TODAY. AFTER ADMINISTERING VACCINE,  WHEN ENTERING VACCINE DOSE GIVEN INTO database IT WAS FOUND THAT CLIENT HAD RECEIVED A MODERNA VACCINE AT ANOTHER FACILITY ON 6/16/2021.