chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red spot at the injection site, swelling, redness decending to the wrist from deltoid, warm to touch.
Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
2.24 - Received 1st dose of vaccine at 2 pm  Pfizer EN6202.  Left arm. Had a little soreness in arm next day and several days later a little bruise.  2.27 -  Noticed around 6 little pimples on my scalp. Just scratched them, they scabbed, thought it was odd.  2.28  Noticed little pustules on my legs. In the coming days they appeared all over my torso and some on my arms as well. Also a few spots on hands, inside ears was scaly and very dry skin on sides of nose where it connects with face.  3.9  Contacted Dr. Rhuemotology, about bumps thinking they might be an reaction to Humira which was started in the fall. She didnt think it was Humira and suggested dermatologist.  Contacted Nurse bVie as well. She didnt think it was the Humira.  3.17  Appointment with Dr.  Dermatology,  She did a punch biopsy on left leg and took a bacterial culture from pustules under left breast.  Notes said after pustules on head appeared on legs, axillae, under breasts, genital area. Papules. Pustules w/ erythema  3.20  Started having issues with left eye, dry and a bit painful. Felt like it was perhaps scratched.  3.22  Dr. prescribed Triamcinolone Cream. Result of biopsy, etc. was that it was not an infection, not psoriasis. It was spongiotic dermatitis which is an eczema rash or reaction to a medicine.  3.22 - Vaccine Received 2nd vaccine dose, same place, 2 pm. Pfizer EN6206 Left arm Did not have soreness, redness, etc. at injection site.  3.22  Left eye very painful.   Ophthamology,   3.24  Dr. diagnosed epithelial basement membrane dystrophy. Protocol was   Besivance (besifloxacin ophthalmic suspension, 0.6%) 1 drop 3x/day for 3 days Genteal gel 4x a day Muro 5% ointment (sodium chloride hypertonicity ophthalmic ointment, 5%), 1 application at bedtime  3.29 Follow up with Dr. She noticed rash on my face that wasn't there before ? under left eye and on eye lids of both eyes. Issue had healed 80%.  3.31  Contacted Dr. about RA flare.  4.1  Was prescribed Methylprednisolone 4 mg dosepk. Took immediately and started to feel better within hours. Elbow swelling went down, energy overall went up.  4.2  Elbow pain greatly reduced, body pustules and bumps going away.   4.10  Elbow pain back, flexibility compromised.  4.22 First day without noticing any new pustules. Elbow pain diminished. Most of elbow flexibility has returned. Left eye issue may
Had an adverse reaction from Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an adverse reaction from Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cognitive impairment (Mild cognitive decline that is affecting his esophagus).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had an adverse reaction from Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Had an adverse reaction from Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient received first dose of Moderna COVID vaccine in Feb-2021 or Mar-2021  Concomitant products included blood pressure medication.  No treatment medication was provided.
Arm (from injection site to elbow) became red and swollen by the end of the day.  Two days later when patient presented, the swelling had went down but the arm was still slightly red and warm.
A report has been received from a Health Professional concerning a 14 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The reporter stated that an administration of expired FLUMIST QUADRIVALENT which started on 09-Jan-2013. The outcome of the event of administration of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Side effects from second shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to the company on 07-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Side effects from second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects from second shot). At the time of the report, VACCINATION COMPLICATION (Side effects from second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Was very sporadic with my periods for the last year prior the the vaccine due to impending menopause.  Since the vaccine I have experienced consistent periods every 28 days approx.
Major throbbing pain in Left Arm at time of vaccine, next day whole body ached and skin sensitive, Swelling and pain at shot site by 3rd day and went to ER. Cortisone OTC and also took Acetaminophen w/codeine, Ongoing but waning.
Child admitted to E.R. on 1/13/10 for severe anemia requiring blood transfusion. Dr. ordered Hemogram Platelet count after injections.
Varicella, Post- vaccination. Seen in our office 04/04/2005 and DX by DR with Varicella. Had vaccine in 1999. Developed rash 4-2-05 and fever of 101 degrees Fahrenheit 4-3-05. Has approximately 30 lesions with small central vesicles, some crusted. Follow-up Information 12-APR-2006: Varicella vaccine break-through. Rash on neck, abdomen and legs on 4-6-06. No fever. Diagnosed with Varicella by Doctor. Less than 50 lesions. Patient age: 7.
dose administered more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered more than 12 hours post puncture) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer-Biontech COVID-19 Vaccine (Dose 2) and Pfizer-Biontech COVID-19 Vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer-Biontech COVID-19 Vaccine and Pfizer-Biontech COVID-19 Vaccine. Concomitant products included NAPROXEN for an unknown indication.    On 20-Jan-2022 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered more than 12 hours post puncture). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (dose administered more than 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other medication includes Non-product related/Other and Over the counter allergy pills.    The vial was first punctured on 19Jan2022 at 4.30PM and one dose was administered on 20-Jan-2022 at 10 AM.  Treatment details were not given.
Flu symptoms--high fever 103.5,  vomiting, chills, nausea. Time--still ongoing
Headache, Sedation, Angioedema, Rash, NauseaVomiting, Lips swelling and tingling, Migraine, Oral itching, Arm redness and swelling. Narrative: Within 7 minutes of 1st dose on 12/31/20 noted lips tingling and swelling and development of migraine. Treated with an abortive migraine medication, and diphenhydramine. Self administered acetaminophen and diphenhydramine prior to 2nd dose on 1/26/21. After dose noted itching in mouth then nausea and headache. Left work early on 1/26/21. Noted fatigue over the next few days, Also rash and swelling at injection site. Did seek medical attention at ER and treatment with steroids (route and specific med not known) and diphenhydramine. No known prior COVID infection.
Information has been received from a receptionist concerning a patient who on an unspecified date was vaccinated with one dose of Varivax. Subsequently the patient "came down with a mild case of shingles, herpes zoster". Unspecified medical attention was sought. There was no product quality complaint involved. No further information is available.
Persistent and intense upper arm pain in the arm where the flu shot injection was given. The pharmacist told me that the vaccine I was receiving was a high dose recommended for people age 65 and older. I usually have a sore arm for a day or two but this has persisted for a month. Upper left arm aches most of the time and a sharp pain occurs when I move the arm in an upward motion.
Experienced a bad case of vertigo.  Urgent Care doctor prescribed Meclizine.  Meclizine had no affect so I discontinued use,
Patient received an undiluted form of the Pfizer COVID vaccine. Patient's parents and PCP were contacted. No adverse effects reported at this time
swollen neck; a little tongue swelling; eye swelling; nose area swelling; face swelled up; hands swelled up; This is a spontaneous report from a contactable consumer (patient's parent). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 25Mar2021 (at the age of 34 year old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Mar2021, patient received the vaccine and she developed swollen neck, a little tongue swelling, eye swelling and nose area swelling. Also her face, hands swelled up. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report has been received from a Registered Nurse refers to a 16-year old patient of unknown gender. The patient's medical History, concurrent conditions and concomitant therapies were not reported. On 07-SEP-2017, the patient received an improperly stored dose of GARDASIL 9 (lot # N000326, expiration date 14-OCT-2019; dosing details unknown) for prophylaxis. The temperature excursion occurred on an unknown date at a temperature of 35.4 Fahrenheit (F) for a time frame of 8 hours. The previous temperature excursion was at 34.9F for a time frame of 2 hours. The call was because of a data logger. No adverse effects were reported. Sender's Comments: US-009507513-1710USA004063.
This spontaneous report was received from a pharmacist, regarding an unspecified number of patients (age and gender were not provided). The patients pertinent medical history, and drug reactions/allergies were not provided. On an unspecified date, patients received a dose of M-M-R II, HSA (route not provided, lot # reported as J002502, expiration date in 28-FEB-2015). Co-suspect therapy and concomitant medications were not provided. It was reported that an unspecified number of patients at unspecified times might have received doses of  M-M-R II that were exposed to 57F for 41 hours. The pharmacist also reported that there were two doses of M-M-R II that were administered, which might have been improperly stored. No adverse effects were reported. Additional information has been requested.
Developed swollen ankles at some point between date of vaccination and date symptom was recognized in late May.  Creatine level and BUN elevated upon work up for Kidney Disease or reaction to Amlodipine medication.  No suggestion from doctor at this point that it's related to vaccination but never had swollen ankles before.
Intense chills, uncontrollable shaking & teeth chattering for 2 hours (hours 12-14 after injection), leg aches so great unable to stand. Fever measured up to 100F while on 400mg ibuprofen, temperature not taken during the intense chills.  Ongoing fever of around 100F from hours 14 - 24, chills, exhaustion, and general malaise. continued treatment with 400mg ibuprofen.  Headache and exhaustion from hours 24 post vaccine through day 5.  Ibuprofen and tylenol taken to mitigate symptoms with marginal benefit.   Minimal muscle soreness at injection site.
Pt. had a flu shot at the flu shot clinic for community. Immunization was given in R deltoid IM. Pt. states there was "significant pause and movement of needle" while in her arm. After the vaccine she had achiness in the shoulder that lasted 8 wks after and continues to be present intermittently. ROM reaching forward is limited due to pain.
MMR and Varicella vaccines were given on 04/12/2002. Fever of 100-101 deg. F from 04/19-04/21/2002. 3mm papules on face on 04/21 the 40-50 on face, trunk and back on 04/22. Papules are pruritic.
L upper arm redness, swelling warm to touch 2 days after receiving BOOSTRIX + VARIVAX to same arm.  Swelling, redness started several hours after receiving vaccine.  Last noc h/a, sa dizziness, fever yesterday - feeling fine today.  Came in 5-21-08.
Information has been received from the grandfather of a 2.5 year old male who in April 2001 was vaccinated with a dose of varicella vaccine. In the beginning of October 2001, the pt developed a rash near injection site and under his arm. The grandfather reported that the pt was going to a dermatologist for further evaluation. Additional info has been requested.
runny sinus and sore throat, slight headache, low fever, chills - all happened 4 hours after vaccine and have gotten worse but appear to be stable after 6 hours
Fever, body aches, migraine, swelling/redness/warm/hard lump at injection site, nausea. Symptoms started approximately 6:00pm 12/18/20
STOMACH PAIN; TOP/MIDDLE OF BACK HURT ALL DAY YESTERDAY; HEADACHE; RIGHT ARM SWELLING; INJECTION SITE REDNESS- SIZE OF SILVER DOLLAR; TEMP OF 98.6; FATIGUE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced temp of 98.6. Laboratory data included: Body temperature (NR: not provided) 98.6 F. On 21-MAR-2021, the subject experienced injection site redness- size of silver dollar. On 21-MAR-2021, the subject experienced right arm swelling. On an unspecified date, the subject experienced stomach pain, top/middle of back hurt all day yesterday, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, injection site redness- size of silver dollar, right arm swelling, headache, stomach pain, top/middle of back hurt all day yesterday, fatigue and temp of 98.6 was not reported. This report was non-serious.
Extreme Dizziness and Vertigo onset exactly a month after second dose. No seasonal allergies. Antibiotics have not worked.
Woke up that night; Massive headache; Left arm pit was swollen; Tired; Fever; Sweats; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 29Mar2021 at 07:00 AM, as dose 1, single, for COVID-19 immunization. The patient's medical history included COVID-19 positive from Oct2020. The patient's concomitant medications were not reported. On 30Mar2021 at 02:00 AM, the patient woke up that night with a massive headache and her left arm pit was swollen. The patient took paracetamol (TYLENOL) and was tired the entire next day (30Mar2021 at 02:00 AM), but her headache felt better. In Mar2021, the patient also experienced a perceived fever and had sweats. The patient continued to take paracetamol to treat her symptoms. The patient wanted to know more information on how long the side effects could last. The patient was scared to get the second dose because of the possibility for side effects being worse and she is getting married a few days after the second dose. The patient wanted to know if she can delay the second dose. The patient was recovering from "Massive headache". The outcome of the other events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Patient was given flu shot around 3:35 pm per notes. RN (writer) was informed at about 4:10 that patient wasn't doing well. Patient was red all over her face and neck and reported feeling hot and cold. Patient said that she 'did not feel like herself, thinking and speaking slowly' per pt.  Provider was requested to evaluate patient and during this time patient reported throat tightness so  Epi-pen (0.3 mg) per protocol was administered. Standard clinic workflow was followed for vital signs monitoring (stable) and also gave 125 mg IM solumedrol and 50 mg po benadryl per provider's recommendation and with permission of patient. These meds were given at 1627. Patient reported that her throat tightness was resolved within 3 minutes of epi administration and was able to swallow normally. Patient was monitored until about 1702 and was cleared for discharge by Dr. who supervised the visit and reaction protocol/treatment plan that was followed. RN walked pt out to clinic for discharge.
Injection site - red circle (kept getting bigger) hard, hot to touch and very sore. No fever.
Was found by her family after collapsing on 06Jan2021 /syncope; extreme fatigue; sleepiness; headache; vomiting; weakness /notes 3/5 strength; difficulty speaking /speech disorder /vocal weakness; difficulty walking /gait disturbance; lower extremity weakness /progressive lower extremity /Muscular Weakness; hyporeflexia; Vitamin B12 Decreased; difficulty speaking /speech disorder /vocal weakness; This is a spontaneous report from a non-contactable consumer (patient). A (age: 39; unit: unknown) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EJ1686), intramuscularly at left arm on 04Jan2021 at single dose for covid-19 immunisation. Medical history included hypothyroidism, attention deficit hyperactivity disorder, shellfish allergy. Current illness was none. Concomitant medication included levothyroxine, lisdexamfetamine mesilate (VYVANSE). The patient previously took ceclor and experienced drug hypersensitivity, took first dose of bnt162b2 at single dose for covid-19 immunisation and experienced mild symptoms after the first vaccination, but no neurologic or vascular symptoms at that time. Patient experienced extreme fatigue and sleepiness the day following her second vaccination for Covid 19 and was found by her family after collapsing on 06Jan2021 at 05:30. Upon arousal, she experienced headache, vomiting, weakness, difficulty speaking and difficulty walking with lower extremity weakness. She was taken to urgent care and subsequently admitted for evaluation at hospital and found to have a normal chemistry, blood count, normal lumbar puncture and normal imaging of her neck and brain. Discharge summary notes 3/5 strength and hyporeflexia throughout. Patient had tele visit consult with Psychiatry and Neurology. She was subsequently to be discharged to a Facility without explanation for her sudden onset of progressive lower extremity and vocal weakness. Symptom: Asthenia, Blood Thyroid Stimulating Hormone Normal, Computerized Tomogram head, Computerized tomogram head normal, CSF cell count normal, CSF culture, CSF protein normal, fatigue, full blood count normal, gait disturbance, headache, Hyporeflexia, Lumbar Puncture Normal, Metabolic Function Test Normal, Muscular Weakness, somnolence, speech disorder, Spinal X-Ray Normal, syncope, Vitamin B12 Decreased, vomiting. Serious criteria was permanent disability and the patient was hospitalized for 4 days and had emergency room vist. Existing hospitalization was not prolonged. Lab Data on 06Jan2021 included: Normal BMP, CBC, normal TSH (thyroid stimulating hormone), low B12, Lumbar Puncture: normal, cell count and protein, culture pending, Cervical Spine X-ray: Normal, CT brain (non contrast): normal. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Facial flushing, temperature 103 and vomiting.  Cellulitis left upper arm.
same symptoms as when I had Covid in March 2020.  Pain, fatigue, chills, cough, ...
I felt dizzy; Walked like if I was drunk,Felt like I was unbalanced; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I felt dizzy) and GAIT DISTURBANCE (Walked like if I was drunk,Felt like I was unbalanced) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced DIZZINESS (I felt dizzy) and GAIT DISTURBANCE (Walked like if I was drunk,Felt like I was unbalanced). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 1 dosage form as required. On 13-May-2021, DIZZINESS (I felt dizzy) and GAIT DISTURBANCE (Walked like if I was drunk,Felt like I was unbalanced) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) unknown. On an unknown date, Computerised tomogram: unknown (Inconclusive) unknown.         Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  Patient was put some fluid but patient was not  able to tell the name of the fluid.   This case was linked to MOD-2021-127338 (Patient Link).