chrisvoncsefalvay/vaers-outcomes huggingface dataset:
uncomfortable; Arthritic pains/pain moved up to left ankle; burning sensation in right foot; swelling in both feet; left foot pain/side of foot is painful to touch; crook in her foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch  ), FOOT DEFORMITY (crook in her foot), BURNING SENSATION (burning sensation in right foot), PERIPHERAL SWELLING (swelling in both feet) and DISCOMFORT (uncomfortable) in a 51-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.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], LEVOTHYROXINE SODIUM (SYNTHROID) and ANGELICA SINENSIS ROOT, CIMICIFUGA RACEMOSA ROOT, DIOSCOREA SPP., GLYCINE MAX (PHYTOESTROGEN) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch  ) and FOOT DEFORMITY (crook in her foot). On 29-Jul-2021, the patient experienced BURNING SENSATION (burning sensation in right foot) and PERIPHERAL SWELLING (swelling in both feet). On an unknown date, the patient experienced DISCOMFORT (uncomfortable) and ARTHRALGIA (Arthritic pains/pain moved up to left ankle). At the time of the report, PAIN IN EXTREMITY (left foot pain/side of foot is painful to touch  ), FOOT DEFORMITY (crook in her foot), BURNING SENSATION (burning sensation in right foot), PERIPHERAL SWELLING (swelling in both feet), DISCOMFORT (uncomfortable) and ARTHRALGIA (Arthritic pains/pain moved up to left ankle) outcome was unknown.            Patient reported that a week and a half after the second dose she experienced left foot pain and a crook in her foot which she went to her podiatrist and was given an ace band for her foot. Patient reported after she has been experiencing a burning sensation in her right foot, swelling in both feet on 29 July 2021, uncomfortable, arthritic pain , pain in left foot moved up to left ankle, discomfort, side of foot was painful to touch.  No treatment information was provided.
Swelling in left axillary lymph node and left chest wall.  Instructed to wait one week and then have an ultrasound done - ultrasound will be scheduled the week of 03/15/2021 if swelling has not resolved.
Tested positive for the Covid virus after getting the Covid vaccine in Apr2021; Tested positive for the Covid virus after getting the Covid vaccine in Apr2021.; This is a spontaneous report from a contactable consumer (patient's sister). This consumer reported for her sister a female patient that a female patient of an unspecified age received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: unspecified, Expiry date: unknown), via an unspecified route of administration on an unspecified date in Apr2021 at as dose number unknown, single for COVID-19 immunization. The patient' medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for the covid virus after getting the covid vaccine in Apr2021. Patient underwent lab test I was covid test result was positive on unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed; information about lot/batch number cannot be obtained
A 16 year old female patient receiving a RabAvert post-exposure series, developed a rash. She was exposed to a rabid raccoon and received her first injection of RabAvert on 5/12/02. The patient received her fourth shot on 5/26/02 and developed some rashes on her back on 5/27/02. These rashes were dot size in the beginning and grew larger. They were raised, scaly, itchy, and not migrating. In the physician's opinion they were not hives. The patient had an existing dermatologic condition: pityriasis rosea, to which the physician suspected this incident is related. The physician wanted to rule out the possibility of an allergic reaction with RabAvert. The patient had no significant prior medical history and was not on any other medications. The physician assessed the events as possibly related to the RabAvert treatment. Follow-up information received 6/10/02: The physician confirmed that the event was not urticaria. There were no lab tests performed to rule out the possibility of an allergic reaction. The rash on the patient's back was considered to be pityriasis rosea. Benadryl was given for this reaction with little help except a decrease in itching. The patient did have a fifth dose of RabAvert without any problem. Follow-up information received 6/14/02: The physician confirmed that the event was pityriasis rosea, not related to RabAvert vaccine.
Pt in clinic for dose #1 of Covid vaccine.  Staff accidentally drew up and administered a bivalent vial instead of a monovalent vial.
This spontaneous report was received from a physician, and refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, and concomitant therapies were not reported. On unspecified dates, unspecified patients were inadvertently vaccinated subcutaneously with doses of VARIVAX (lot # and expiration date not provided), M-M-R II (lot # and expiration date not provided) and PROQUAD (lot # and expiration date not provided) for prophylaxis. All lots of VARIVAX, M-M-R II and PROQUAD were reconstituted with properly stored sterile diluent (MRK) (lot # and expiration date not provided). No adverse effect was reported. The temperature excursion was not provided. Digital data logger involved.
Blurry, foggy vision just on the left eye. Notice about three days after vaccine.
Complete loss of control - 9-13-08. Hospitalized five days. Diagnosed virus syndrome. Home doctor said had Guillain Barre syndrome.  4/8/09 Received hospital medical records of 10/5-10/8/2008. FINAL DX: probable viral syndrome; dental abscess. Records reveal patient experienced generalized weakness, muscle pain, chills, productive cough,  fever 101, toothache x 2 days.  Tx w/antibiotics.  ID consult done.  Fever thought to be from dental abscess.  D/C on continued oral antibiotics & referred to dentist & PCP.  4/20/09 Received vaccine & PCP medical records of 10/27-10/30/09. FINAL DX:viral syndrome, improved. Records reveal patient received flu vaccine on 10/2/08.  RTC 10/27 seen s/p hospitalization w/no new c/o.  RTC 10/30 w/persistent fatigue & body aches.  Supportive tx given.  No further med records available.
numbness around vaccine site.  nausea.  typical reaction she has with vaccines.   feels better after 10 mins
Severe headache; chills; fatigue; muscle aches. These symptoms lasted through the following day but abated within 48 hours.
Late Saturday afternoon starting not feeling well. Sunday didn't feel good , cold and then I started coughing, asthma, and none of my usual meds helped.  Late evening Sunday the fever broke, but not the coughing and this continued until Thursday morning. I have a massage therapist friend that thought she could help the lymphatic system with a massage and it did. I saw her again Saturday morning and the cough stopped. Sunday afternoon started a UTI infection and had to get antibiotics on Thursday and still have to get more since it didn't clear up. In the meantime my whole body ached and when I went to the dentist my BP was elevated.  4/2 I felt the worst of all the days since the shot. On the 3rd started feeling better and yesterday my BP was good and just took it and it up again, but hadn't been elevated prior to the shot. In fact I felt fairly well prior to the shot. Based on how I've felt since the shot I'm electing not to take the 2nd shot.
Swollen right entire armpit  following day; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 66-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm right on 17Feb2021 at 09:00 (at the age of 66-years-old) as dose 2, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. No known allergies were reported. The patient previously received first dose of BNT162B2 (solution for injection), via an unspecified route of administration in arm right on an unspecified date as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 18Feb2021, the patient experienced swollen right entire armpit following day. Therapeutic measures were not taken as a result of event. The outcome of the event was reported as not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cellulitis of right thigh  At this point, there is definite concerns for cellulitis.  I would be concerned that the barrier on the skin had been breached and perhaps normal skin flora had been introduced during the vaccination process.  I recommended coverage with cephalexin for cellulitis.  I recommended that mother watch closely over the weekend for improvement.  If there is no improvement over the weekend, I encouraged her to contact the clinic and we could broaden coverage for MRSA, likely with Bactrim.  Further evaluation could be taken with ultrasound if needed looking for pocket of purulent fluid collection for drainage if this continues to be problematic but hopefully this will not be needed as the family is leaving town on Wednesday.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment was provided to the patient.
I have noticed some short term memory or recall issues that is noticeable by me.  My family has also noticed this delay of recall.
(L) upper arm swelling, warmth and redness from above elbow to arm pit. Started at 24hrs after vaccine and progressed. We are seeing pt as 36 hrs after vaccine admin. Has full range of motion, normal strength, just slight ache pain. Recommended Ibuprofen on second day of symptoms.
Patient received influenza (right arm) and Pneumococcal (left arm) vaccines on 10/2/13 at pharmacy. Pt returned on 10/4/13 complaining of pain and inflammation on left arm from injection site to below the elbow. RPh on duty recommended physician visit and provided vaccine details to patient.
On Monday evening, I started feeling rather weird, rather out of it. During the night, I was having trouble sleeping and woke up with a fever of 100. I took Tylenol and went back to bed.  When I finally got up probably around 10 a.m., I was not feeling well at all.  I had body aches, a headache, stomach cramps, chills, fever, my arm was very sore, very tired, and exhausted. I fell back asleep early afternoon and woke up with a 101.7 fever. Took Tylenol & continued to not feel well.  Went to bed around 10 p.m. and slept for 12 hours.  Wednesday, I was still very exhausted, but not as many body aches. That evening, I noticed my face had many small pimples on it.  The next morning, I woke up with a rash and redness around the injection area, a rash on my face and on other areas of my body, which caused itching/tingling sensations.  I called the health department nurse and she indicated that the rash was also a side effect of the vaccine.  She suggested Benadryl, but I mentioned that I don't handle that medication very well.  I did use some Benadryl cream on my arm for the itching.  Not sure whether the cream caused a reaction, but I once again became very tired and took a nap.  I also developed a stuffed, clogged left ear, which affected my hearing.  This sensation came and went several times from Thursday through Sunday. On Friday, I still had a rash and experienced some fatigue.  When I woke up on Saturday, I finally felt like I was "normal" again.
Dizzy; Pain in the vaccinated Arm; Tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in the vaccinated Arm), FATIGUE (Tired) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Dizzy), VACCINATION SITE PAIN (Pain in the vaccinated Arm), FATIGUE (Tired) and NAUSEA (Nausea). On 13-Feb-2021, VACCINATION SITE PAIN (Pain in the vaccinated Arm) and NAUSEA (Nausea) had resolved. At the time of the report, DIZZINESS (Dizzy) and FATIGUE (Tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-NOV-2015 10:08, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 10.7 and 2.3 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
I started to get swelling and firmness and warm at the injection site .... 8 days later still have it and it sometimes is itchy
A nurse reported that a 13 month old male received Prevnar, TriHibit and IPV vaccines on 11/16/00. Within 24 hours, he developed "migratory hives" over his body and swelling around the eyes. The reporter indicated that the child had mild congestion and a rash at the time of immunization. Follow up information received 12/29/2000 indicated the patient recovered.
Patient's parent requested Moderna vaccine for patient's booster. Patient was asked to wait 15 minutes after shot, both parent and patient stated that patient did not have any adverse reaction after waiting 15 minutes. Realized after administration of vaccine that Moderna is not approved as a booster dose for individuals under 18 years of age.
Right leg swelling with circumference 9 1/2" thigh; left leg circumference 9 1/4" thigh.
Arm sore, headache, fever, myalgia stared about 12 hours after 2nd dose of vaccine.  Reactions lasted one day.
sever reaction to vaccinations and flu shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 27-Nov-2020.  This case is linked to case 2020SA344429.  This case involves an unknown age female patient who had sever reaction to vaccinations and flu shot (vaccination site reaction), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had sever reaction to vaccinations and flu shot (vaccination site reaction) after patch test, (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE. She did not get the shot every year.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
L hand numbness; This is a spontaneous report from a non-contactable other health care professional. A 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: EN6205) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date during her 15-minute waiting period after the injection, the patient began to experience L hand numbness.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. Patient was Stable to go home and follow up with PCP. Therapeutic measures were taken as a result of L hand numbness included Treatment with water. The outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected.
Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA258563 (same reporter). This case involves a five-years old patient (gender not reported) who received a 0.5 mL dose of FLUZONE QUADRIVALENT lot UI998AC via intramuscular route in the left deltoid on 24-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that the FLUZONE QUADRIVALENT as delivered later than it should have and the product was out of temperature range (shipping stability). It was unknown if any adverse event was occurred or not following the vaccination. 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 Directive 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. List of documents held by the sender: none.
left arm swelling, redness, pruritus, left and right axillary lymphadenopathy
This case was reported by a medical assistant and described the occurrence of hand and foot swelling in a 19 month old female pt who received Infanrix. On 2/9/04, the pt received the first dose of Infanrix (610A2) in her left arm. On the same day, the pt received an injection of IPOL. At an unspecified time following administration of Infanrix and IPOL, on 2/9/04, the pt experienced hand swelling, foot swelling, fever and cough. The following day, on 2/10/04, the pt was hospitalized. she was treated with acetaminophen. The medical assistant stated that, "all lab values were reported in normal range. On 2/12/04, the fever and cough resolved and the hand and foot swelling improved and the pt was discharged from the hospital. The medical assistant considered the events to possibly be related to vaccination with Infanrix. A sikle cell preparation done on 12 February 2004 yielded negative results. The immunization series was neither delayed nor discontinued.
pt reported a rash on face, scalp and neck. rash still persists 4 days after injection.
Second dose of vaccine given too early (after 21 days). First dose given 5/17, dose 2 given 6/7. Patient reports mild side effects  (type unknown) after both the first and second dose of vaccine.
11/7/11 c/o rash all over body & itched & 11/11/11 was prescribed miconazole cream > nurse. 11/15 MD assessment - large saline red circumscribed and serpentine areas to both deltoids and upper shoulder then scratched & abraded 2-3 mm lesion over most of body. Skin biopsy. Fluconazole qd for 4 days.
During administration of the vaccine into the patient's shoulder, the needle cap detached from the syringe as the syringe plunger was being pressed in and the vaccine spilled onto the patient's shoulder instead of entering the patient's body. Called CDC and revaccination was recommended according to their guidelines.
Initial dizziness, light-headedness, brief shortness of breath, elevated heart rate 2 days of flu symptoms: mild fever, chills, nausea, diarrhea, headache 10 days (so far) of heart palpitations, elevated heart rate, and spikes in blood pressure
PREVNAR 13 given when should have been IPOL. Client still in clinic when error realized. IPOL given. Client left with parent in no distress. No reactions reported.
difficult breathing-4 hrs; dizziness immed-4 hrs; nausea immed; muscle aches-5hrs-19hrs; h/a 4 hrs- 26 hrs;
1/30/2021 3:30 am 101 fever, body aches, fatigue continued all day, treated with Motrin  1/31/2021 woke up with 100 temp, subsided and had a normal day  1/1/2021 100 degree temp all day, left work at 12:00, severe fatigue and nausea, treated with Motrin and Zofran 1/2/2021 severe fatigue, brain fog, headache, nausea, treated with Motrin and Zofran 1/3/2021 woke up with swollen tongue, "scalloped" on the edges, nausea, fatigue, saw NP at work place clinic regarding tongue. Rapid swabbed for COVID 19-negative, also swabbed with a send off test-negative 1/4/2021 nausea, called out of work, developed sores on tongue, rx "magic mouthwash," continued Motrin and Zofran 1/5/2021 symptoms subsided mostly, continued fatigue
This spontaneous report was received from a 36-year-old female, non-pregnant patient who was a company representative and was reporting on herself. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 19-SEP-2017 at 11:10, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) lot # N011867 for prophylaxis (dose, route of administration, expiration date were not reported). On the same day around 8:00 PM, the patient experienced sore throat, low degree fever, fatigue, severe injection site pain (upper deltoid area in right arm), muscle pain in right arm, right side armpit soreness/pain and swollen right side armpit. The patient received 1 tablet of ADVIL as a treatment however it was not helpful. At the reporting time, the patient not recovered from the events (all were ongoing). The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.