chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6/24 - Mom said (R) upper arm red and swollen, hard to touch. Mom drew a circle around the injection site - area larger. Advised per doctor to apply cool compress, give BENADRYL every 8 hours, site should improve over 48 hours/if red streak N/T seek emergent care.
Moderna vaccine was given to a 12 year old  female when it has not been approved to be administered to this age group.
CIDP; numbness in her legs; fracture her ankle; This case was reported by a consumer and described the occurrence of chronic inflammatory demyelinating polyradiculoneuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chronic inflammatory demyelinating polyradiculoneuropathy (serious criteria GSK medically significant), numbness in leg and ankle fracture. On an unknown date, the outcome of the chronic inflammatory demyelinating polyradiculoneuropathy, numbness in leg and ankle fracture were unknown.   It was unknown if the reporter considered the chronic inflammatory demyelinating polyradiculoneuropathy, numbness in leg and ankle fracture to be related to Shingrix.  The patient received her first shingrix vaccine on 6/8/2020. On 7/13/2020 she noticed something was wrong. On 7/14/2020 she woke up and was doing chores around the home and her legs went numb causing her to fall to the ground, she pulled herself up using her bed but fell again to her knees and was unable to get up again. She called 911 and was taken to the hospital where they treated her with an IV and was discharged home to be treated as an outpatient. Once home she fell once again however she was outside her home, she called 911 again and asked to be taken to a different hospital, they admitted her to the hospital.  She had to endure over 2 months of physical therapy to regain the ability to walk again. She underwent 5 treatments of plasma infusions however had to stop this treatment when she contracted MRSA in the hospital. She still suffers numbness in her legs which has affected her balance, which caused her to fall and fracture her ankle.
numbness in neck & funny sensation in lower face;1SEP95 no response to f/u request;
Child received immunizations on 02-26-07 (Monday) late evening, per mom, started to noticed swelling to left deltoid and redness around injection site with low grade fever 100; then, 02-27-07 mom noticed more swelling to left deltoid. Reported to main office today 02-28-07, SPHN noted 70 mm induration to left deltoid around injection and 125 mm induration on 2-28-07.
Information has been received from a medical assistant concerning an 11 year old male who on 05-MAR-2009 was vaccinated SC in the left arm with a dose of VARIVAX (Merck) (Dose not reported, lot number 661988/1190X).  The medical assistant reported that on 05-MAR-2009 the patient had hives at the injection site.  The patient recovered from the event on an unspecified date.  The patient sought medical attention by speaking to the physician.  Additional information has been requested.
Acrocyanosis, central cyanosis, mottling, fever to 105.0, papular rash on face, spreading down to the rest of body by morning, lasting 48 hrs.
Patient's husband reported that his wife had gone to the ED with s/s of blood clot.
General malaise, weakness, urticaria &  pruritus mainly on injection arm, but proceeding to other parts of body.  The pruritus is awful & wakes me up at night.
BELL'S PALSY; FACIAL PARALYSIS OF LEFT SIDE Follow-up: To Whom It May Concern, I would like to request compensation for my injuries related to the H1N1 vaccine. I am an ICU nurse and it was strongly recommended for individuals in the healthcare field to receive the H1N1 vaccine. On October 1, 2010 I received the H1N1 vaccine. On December 28, 2010 I woke up with left side facial paralysis accompanied by severe left ear pain. I was taken to the hospital by ambulance, thinking that I was having a stroke. After blood work, CT scan of my brain, and a MRI of my brain I was diagnosed with BELLs Palsy. I was off work for almost one month, in which I had used all of my PTO (paid time off) time in the first 2 weeks. I did not get paid for my remaining time off. Now my mortgage and all of my bills are behind and I am in jeopardy of losing my home, in addition to the mounting medical bills I have acquired. Also, I was, and continue to be, in severe pain. I am a person who hates to take my medicine. I was also on 3 different rounds of high dose of steroids, and Acyclovir. Today, I am still completely paralyzed on the Left side of my face and my vision is severely compromised in my left eye. Below you will find all of my necessary information.
I got the vaccine Apr7th afternoon. While at injection of the J&J Covid vaccine to my left arm, I could felt strong but manageable pain. Except minor pain from the arm, I felt all fine till going to bed that night. I started to get a headache and discomfort all over my body that night and couldn't sleep at all. Next day Apr 8th, my headache became much worse. I also felt extremely tired and got a low fever (98.3 - 99 F). I had to lie in bed for the whole morning. After taking Tylenol in the afternoon, my temperature came down to normal and my headache was also relived. I got a normal sleep Apr8th night, and felt all fine from Apr 9th till now (Apr 14th).
Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-NOV-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018 (strength, dose, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported. The vaccine had two temperature excursions one of 29.9 Fahrenheit (F) for 2 hours 30 minutes and the other of 47.7 (F) for 30 minutes; with a data logger involved. Also it was reported no previously temperature excursions. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because the reporter do not want to be contacted. Sender's Comments: US-009507513-1612USA000346: US-009507513-1612USA000347: US-009507513-1612USA000348: US-009507513-1612USA000349: US-009507513-1612USA000350: US-009507513-1612USA000351.
Redness, swelling & itching at injection site approx 3cm diam NTTP no evidence of infection.
Patient received this dose of ROTARIX on 09/07/2017, 2 days after the listed expiration date. This was discovered when doing end of month inventory. Discussed with district immunization coordinator, Immunization Regional Consultant, and district health director. Recommendation from VFC program is to repeat dose after 28 days. No known adverse outcomes occurred with child. Currently trying to contact mother to notify of dose needing to be repeated.
received less than 0.5ml of a Shingrix second dose (Lot number: 92E7E; expiration date: 8/6/2024), probably 0.2ml were injected; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 92E7E, expiry date 06-AUG-2024) for prophylaxis.   On 24-JUN-2023, the patient received the 2nd dose of Shingrix. On 24-JUN-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: received less than 0.5ml of a Shingrix second dose (Lot number: 92E7E; expiration date: 8/6/2024), probably 0.2ml were injected). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 26-JUN-2023 The permission to have an account on medical information database was declined. The reporter consented to follow up via phone. The reporter reported that due a malfunction of a syringe, a patient received less than 0.5ml of a Shingrix and probably 0.2 ml were injected, which led to incomplete dose administered.
woke up day after vaccination with headache, joint pain, back pain, muscle pain, started having heart palpitations. I have a link recorder in my chest, recorded some of the arrhythmias. Cardiovascular clinic reports frequent PVC's, with some couplets, rapid heart rate, over 100.  Took 2 excedrin migraine, drank water and went back to bed, woke up 90 minutes later, felt better, still not back to normal, Now at 8:30 pm headache, and muscle and Joint pain returning
1/30/21 pt started experiencing lower abdominal discomfort, blood in sinuses, diarrhea, fatigue, taste off. 1/31/21 fatigue continued, headache come and go, pain in lower esophagus cont. Sunday night, end of Monday fatigue pain midway in esophagus, swollen lymph nodes,  2/2/21 fatigue cont., pt went to PCP and diagnosed with oral thrash, PCP did flu and rapid Strep test both negative, also sent culture off for strep, COVID test negative, 2/3/21 pt went to ER with severe throat/esophageal pain/mouth pain, fatigue cont., 2/4/21 help of magic mouth was and suspension pt is still experiencing fatigue, throat/mouth beginning to heal, pt still has white color on tongue, results came back from strep culture and it is negative.
High fever of 104.6 degrees,  siezure which consisted of staring straight ahead without blinking or making any recognition of any activity going on around her or persons speaking to her for at least 2 minutes.  Rash covering body.  Symptoms began on 1-23-03, nine days after the MMR vaccine was administered.  Fever continued for three days, rash continuted for seven days, seizure occurred once on the first day of onset of fever.
Fever of 100.8-100.9 the next day.; Fatigue; Arm soreness; This is a spontaneous report from a contactable other healthcare professional. A 40-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via intramuscular route of administration on 28Jan2021 (Lot Number EL3247), 13:30 in right arm (age at vaccination: 40 years) as, single for COVID-19 immunization. The patient medical history included allergic to drug included bactrim. Concomitant medications included fish oil, gotu kola [centella asiatica] (GOTU KOLA [CENTELLA ASIATICA]), bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) and multivitamins; all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination and post vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via intramuscular route of administration on 07Jan2021, 13:30 in left arm (age at vaccination: 40 years) as, single for COVID-19 immunization. On next day (i.e. 29Jan2021) at 09:00, the patient developed fever of 100.8-100.9, fatigue and arm soreness for which the patient did not received any treatment. The events were assessed as non-serious. The patient underwent lab tests and procedures which included body temperature: 100.8-100.9 on 29Jan2021. The outcome for all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Varicella vaccine breakthrough. Had Varivax on 6-7-02 and 8-17-07. Diagnosed 10-31-07 with Varicella. Had 10 lesions, some with pustules. No fever.
Pt. suffered a fall about 2 weeks ago and had abrasion and received tetanus vaccine and about 48 hours post vaccination she became extremely weak with dysphagia and increased muscle spasm.
I had COVID in December.  Felt like I had it again. All symptoms returned except shortness of breath. Lasted 4 days.
Gave a booster shot to a person too young to qualify to get a Covid-19 Pfizer booster
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021 at 2:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 2:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of the patient was reported as 75.89. No concomitant medications were reported. On 12-Feb-2021, 3 vials were moved to clinic. The vial was initially moved to the fridge on 09-Feb-2021 and proposed beyond use date was 10-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 10:00 A.M., the temperature recorded was 35 degree Fahrenheit and at 11:00 A.M., the temperature recorded was 35 degree Fahrenheit that has been reached by the vial. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. The vial was moved to clinic on 12-Feb-2021. No treatment information was provided. The occupation of reporter was reported as clinic manager. This case was linked to MOD-2022-566976 (Patient Link).
diarrhea, severe vomiting every 15 minutes for 24 hours. neck pain, stiff neck and headache.
Hot red rash from top of left arm down to elbow. Went to a local Urgent Care on 3/8/2021. Was seen by APRN, CNP who was not sure if it was a bacterial infection or an allergic reaction to the vaccination. She outlined the rash with a marker and prescribed an antibiotic with wait and see instructions. I should take Benadryl, but if rash grows outside of marker take antibiotic. The rash progressed down to my wrist and I started the antibiotic. On 3/11/2021 I saw another Dr. at a local HCF. He believed this was an allergic reaction, not cellulitis an said to restart with Benadryl. The rash lasted about one month and gradually went away.
pt arm very sore/swollen @ inj. site. Pt taking around the clock ibuprofen for past 2days & massaged area. Also altern w/hot & cold compress.
Up all night; Arm was sore; Chills/chilling; Temperature went up a little bit; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Up all night), PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills/chilling) and PYREXIA (Temperature went up a little bit) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Depression and Blood pressure.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced INSOMNIA (Up all night), PAIN IN EXTREMITY (Arm was sore), CHILLS (Chills/chilling) and PYREXIA (Temperature went up a little bit). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Up all night), PAIN IN EXTREMITY (Arm was sore) and CHILLS (Chills/chilling) outcome was unknown and PYREXIA (Temperature went up a little bit) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: 100.3 (High) The temperature is still up (100.3 F)..         Patient medical history include blood pressure  Concomitant medication include blood pressure medicine, depression medicine and other medicines.
Family got covid 9 to 10 months prior on same day. 19 yr old had for 1 day, I had for almost 2 was, husband 3 was. Did not need hospital. All 3 of us got the 1st round of vaccine to potentially minimize symptoms of new strain only. Or we would not have taken it. However, I was only one with after effects next 2 day.  Mild case of covid again.
Skin: slightly raised circular maculopapular rash to palms, elbows, knees.  Slightly tender to palpation.  No induration
Swelling of lymph node above collar bone; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included metformin (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN), probiotics (MANUFACTURER UNKNOWN), cyanocobalamin (B12); all for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Apr2021, the patient experienced swelling of lymph node above collar bone. It was unknown if the patient had received treatment for reported event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event swelling of lymph node above collar bone was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Tireness and agitated; Tireness and agitated; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (Tireness and agitated) and FATIGUE (Tireness and agitated) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 027A21A) for an unknown indication.     No medical history was provided by the reporter.  Concomitant products included PROGESTERONE and ESTRADIOL (ESTROGEN) for Menopause, GABAPENTIN for Neuropathic pain, COLECALCIFEROL (VITAMIN D 3) for Vitamin deficiency.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced AGITATION (Tireness and agitated) and FATIGUE (Tireness and agitated). On 12-Mar-2021, AGITATION (Tireness and agitated) and FATIGUE (Tireness and agitated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: inconclusive (Inconclusive) COVID-19 test performed on several times results are not provided..         No treatment information were reported.
C/o itching all over body in the evening after receiving vaccination. Ct took BENADRYL & itching resolved. Itching returned yesterday & ct. concerned it is vaccine related. No other symptoms reported.
It started to itch  about Tuesday the 23rd. My daughter said Mom look at your arm. It is red, warm and itching. It is the size of a baseball. The side of necks also seems a little puffy. I have took Benadryl  and put ice on it. Today the redness and warmness is still these but it is not itching.
The case was received on 21 March 2014 at GPV. Initial misuse report received from a heath care professional on 18 September 2013. A patient had received an expired dose of FLUZONE HD on an unspecified date. No adverse event was reported. List of documents held by sender: none
This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, solution for injection; batch/lot# not reported), via an unspecified route of administration, on Mar 10, 2021, single dose, for COVID-19 immunisation. The patient's medical and concomitant medications not reported. On an unspecified date, patient experienced migraine (last Thursday). She was advised to take steroids today for 6 days. Patient wanted to know if they are going to cause a problem with the COVID-19 vaccine. The outcome of the event: unknown. Additional information on batch/lot number requested. No follow-up attempts needed. No further information expected.
10/3/02 Mother called office to report patient with about 12 itchy, fluid filled vesicles scattered over face, trunk, legs, 14 days after varivax immunization. More vesicles appearing today.
pt recv vax 4DEC98 & immed noticed warm feeling in rt arm;noticed pain, redness, swelling around 7-8PM;stated arm was so sore couldn't stand to touch it;had h/a & generalized body aches;area warm, indurated, sore, itchy;
I, THE PHARMACIST, ACCIDENTALLY ADMINISTERED AN PEDIATRIC PFIZER BOOSTER DOSE TO THE ADULT PATIENT. PHARMACIST HAD INFORMED THE PATIENT REGARDS TO THE INCIDENT IMMEDIATELY AND ALSO INFORMED PATIENT THAT SHE NEEDS TO HAVE ANOTHER ADULT PFIZER BOOSTER DOSE ACCORDING TO THE CDC COVID-19 VACCINE ADMINSTRATION ERRORS REVACCINATION GUIDANCE. PATIENT AGREED AND WILL COME BACK FOR ANOTHER ADULT BOOSTER SHOT. THE PHARMACIST WILL ALSO INFORM PATIENT'S PCP FOR THIS INCIDENT.
Booster shot symptoms of higher than moderate pain spread through left side injection site to wrist, armpit and breast tissue and to shoulder blade. Sinuses throb, temples tender.
injection site got larger, around 1-1.5 inches; itchy; hard lump; small lump; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (small lump), INJECTION SITE SWELLING (injection site got larger, around 1-1.5 inches), PRURITUS (itchy) and SWELLING (hard lump) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE MASS (small lump). On 18-Jan-2021, the patient experienced INJECTION SITE SWELLING (injection site got larger, around 1-1.5 inches), PRURITUS (itchy) and SWELLING (hard lump). At the time of the report, INJECTION SITE MASS (small lump), INJECTION SITE SWELLING (injection site got larger, around 1-1.5 inches), PRURITUS (itchy) and SWELLING (hard lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.