chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe headache; temperature of 100 degrees; felt very tired; This case was reported by a consumer via call center representative and described the occurrence of headache in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced headache, fever and tiredness. On an unknown date, the outcome of the headache, fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the headache, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received dose of the Shingrix vaccine about 2.5 months ago date in her right deltoid, did not know if it was intramuscular. The patient had temperature of 100 degrees and felt very tired, and severe headache for about 3-4 days.  The patient went to her doctor and was tested for influenza which was negative. The follow up consent was granted.
Patient presented to the ER on 6/22/07 with c/o overall malaise and joint pain. Reported increased lethargy at time of visit. Low grade temp of 37.7 at time of visit. Given IV fluids and Dilaudid for pain control. Mutliple labs taken, see below. Diagnoses of Dehydration and myalgias given.
Big splash rash on right calf. Still resolving now. It got pretty ugly, but didn't hurt, and itched only a little. No other possible causes could be found. It was so strange.
Flu like symptoms that are unable to be relieved with over the counter medication. Cramping and contractions as well. I am 34 weeks and due 11/27/21.
Knee pain; Pain that has settled all over her body; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) and PAIN (Pain that has settled all over her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Knee pain) and PAIN (Pain that has settled all over her body). At the time of the report, ARTHRALGIA (Knee pain) and PAIN (Pain that has settled all over her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  Treatment medications included ibuprofen.
Rt arm "swollen, red, warm, sore to touch. Less red than yesterday"  Denies fever, using extremity without pain.  Recommended Tylenol or Ibuprofen and warm compresses for discomfort.  Suggested child see physician is no improvement.
Developed rash under right arm  raised bumps (no fluid) clusters extremely and constantly itchy
Patient stated that her eyes became blood shot and irritated and that she had blurry vision and photosensitivity lasted approximately 24 hours, contacted her doctor who said that was probably a reaction to the serum (as listed on the VIS) and she is following up with an ophthalmologist / optomatrist.
Quadracel was administered to an 8 year old, no AE; Quadracel was administered to an 8 year old (off-label), no AE; Initial information received on 19-Aug-2019 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a eight years old male patient who was administered fifth dose of vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot number and Exp. Date not reported) via unknown route in the left arm, on 12-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was also a case of overdose.  The office has not heard anything from the parents saying there have been any issues.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
- Pt began experiencing a macular papular rash to hands, upper & low Ext. (+) pruritis. Tx PREDNISONE 20 mg 1 BID x 7 days, ZYRTEC 10mg, 1 QD x 30 days, ZANTAC 150mg 1 BID x 30 days, BENADRYL 25mg - PRN.
Assessed 6/11/15 and noted left upper arm red, inflamed, tender, warm, itching since 6/9 evening per patient.
36 hours after the 2nd dose, I have a rash on my chest, stomach and back, and neck
No addditional adverse effect reported; Incorrect product storage; This spontaneous report was received from an unspecified reporter, and refers to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 02-MAR-2021 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S024369, expiration date: 06-AUG-2021, for prophylaxis.         On an unspecified date, before admninistration, the dose of varicella virus vaccine live (oka/merck)(VARIVAX) underwent temperature excursions of 14 Fahrenheit degrees (°F) to 46 °F for 2 hours. There were no previous temperature excursions.  Call was made by the data logger.   After administration no adverse effects were reported.
A month after vaccine, started feeling flu symptoms. Took Home COVID-19 test, and it was negative. Went to Urgent Care and got tested and it was positive. Dr said that it's probably long COVID. Was prescribed Paxlovid, it didn't help. Went back to Dr  and had low Blood Pressure. Dr. asked me to check back in after a month, unless things get worse.
Local redness to L upper arm near site of DTaP and IPV injection began within 3 hr after vaccines received. L shoulder area and L upper arm became increasingly erythematous, swollen, and warm over the next two days. On 9/11/02, dorsi at foot had erythematous small clustered spots and back had urticaria. Site of DTaP needle entry had small papule which gradualy recovered and disappeared 9/17/02 visit. By 9/15/02 very improved. By 9/17/02 only slight swelling L arm.
she also had Covid; she also had Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2021, outcome "unknown" and all described as "she also had Covid". Therapeutic measures were taken as a result of covid-19.  Clinical course: It was stated she had 3 doses of the Pfizer Covid 19 vaccine, she also had Covid back in August and received special treatment.  The lot number for bnt162b2 was not provided and will be requested during follow up.
1 1/2hr p/vax started inconsolable crying-screaming 4-5 hr;lt leg swelled from knee to hip;pt given APAP & ice leg;problem resolved by 2AM;
Very dark, smelly urine; Very dark, smelly urine; Woke up with savage migraine; Severe neck pain; Severe kidney pain; Could barely walk; Blood pressure was high; Headache so bad; Nausea; Barely eat food; Sleep through all day and next night; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 26Apr2021, at 15:30 (at the age of 49-years-old) as dose 2, single for COVID-19 immunization. Medical history included lyme disease, babesiosis and bilateral kidney angiomyolipoma. The patient had known allergy to most antibiotic (unspecified), allergy to scallops and allergy to some prescription pain killers. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included herbal remedies (MANUFACTURER UNKNOWN) for Lyme disease from an unknown start date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021, at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunization. On 28Apr2021, at 04:00 morning, the patient woke up savage migraine, severe neck pain and kidney pain due to which she could barely walk; on same day, the patient's blood pressure was high, headache was so bad, which brought nausea to the patient. It was reported that, the patient drank lots of water but there was no relief, could barely eat food and sleep through all day and next night. On 29Apr2021 next day, the patient experienced very dark and smelly urine (which was never happened before) but she felt better, as if she would never been sick the day before. Weird. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of headache and included treatment with paracetamol (TYLENOL) from an unknown start date to an unknown stop date and the TYLENOL did not help while took twice. No therapeutic measures were taken as a result of other events. Since the vaccination, the patient had not been tested for COVID-19. On 28Apr2021, the patient underwent blood pressure test and the result was blood pressure was high. The clinical outcome of the events was unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
cold sweats; lethargic; fever; chills; stiff, painful neck (back of neck) (turning radius without more pain was very small); painful neck (back of neck) (turning radius without more pain was very small); headache; large swollen lymph node in neck (right side); Pain in neck irradiates more when coughing; 1 week after 2nd dose nose infection very prominent again (same nostril); This is spontaneous report from a contactable consumer (patient herself). A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration in right arm on 19Feb2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included panic disorder. Patient (self) has no underlying medical issues outside of panic disorder. No known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), trazodone, doxycycline, sulfamethoxazole, trimethoprim (BACTRIM); All received in two weeks within the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on 28Jan2021 as a single dose for COVID-19 immunisation and presented with a nose infection (left nostril, suspected MRSA), prescribed doxycycline for 7 days. Infection reduced (but not completely resolved). The patient did not receive other vaccine in four weeks. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that, second dose 19Feb2021 approx. 1 week after 2nd dose (on an unspecified date in 2021) nose infection very prominent again (same nostril), prescribed Bactrim for 10 days. On 02Mar2021, patient experienced lethargic, fever, chills, stiff, painful neck (back of neck) (turning radius without more pain was very small), headache, large swollen lymph node in neck (right side). Pain in neck irradiates more when coughing. On 03March2021, patient experienced fever, chills, and cold sweats in addition to the same issues as 02March2021 with no resolve or progress on symptoms reducing. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included rapid COVID test: Negative, nasal swab: Negative on 04Feb2021 (performed one week after 1st dose), blood work: Nothing standing out to support symptoms, heat CT: Nothing standing out to support symptoms, neck CT: Nothing standing out to support symptoms completed in the ER, nasal swab: Negative, rapid COVID test: Negative on 02Mar2021. The events were considered as non-serious by the consumer. The patient was treated with Bactrim, fluids. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021235826 Similar report from same reporter
swelling at the injection site; pain at the injection site; This case was reported by a consumer and described the occurrence of injection site swelling in a 49-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received the 2nd dose of the shingrix vaccine a week before the reporting date. The patient would not provide any additional information. The reporter did not consent to follow-up.
So it is not an event per se but I have been diagnosed with gestational diabetes and then I went to the DR and I was borderline pre-eclampsia. I had to do a 24 urine sample and we are just waiting on the results of that. I had a miscarriage in July of 2020. My estimated date of delivery for this child is 9/11/2021.
The patient is immunocompromised received 0.5 ml as a second booster dose instead of 0.25 ml
Bilateral lower extremity pruritic urticaria to the knees on 16Jan2021, responsive to 25mg PO Benadryl.  Progressed on 18Jan2021 with pruritic urticarial from feet to chest level, responsive to 25mg PO Benadryl, added 10mg daily Zyrtec.  No recurrence of urticaria, pruritus subsided 20Jan2021, Zyrtec discontinued on 21Jan2021 without symptom recurrence.
Within 5 minutes after the shot on Wednesday my heart started hammering in my chest.  The EMT's were called over and checked my pulse and blood pressure, and the arrythmia ceased after a few minutes.  They said unless I wanted them to take me to the hospital I was OK to leave after the waiting period was up.    Yesterday, Sunday Januart 31,  I had a 2nd repeat episode of arrythmia which lasted a few minutes then went away.
on the following day she developed chills, shakes, malaise, most likely fever (was not able to take temp). symptoms continued 24 hours with assistance of supportive meds. two days later, developed blisters all over lips and tongue was covered with canker sores
Day 8: right knee joint pain, slight swelling, and slight numbness. Left and right hand joint pain.  Day 9: same as day 8 Day 10: knee no longer in pain. Hand less but still joint pain. Left foot joint pain, slight numbness and swelling, and left ankle joint pain and swelling.  Day 11: only left foot and ankle remain painful. Day 12: same as day 11.
Child was told possibility of lightheaded/dizziness after vaccine HepA and HPV administered in each arm. I went to grap shot record, Mom calls me, states that she fainted.  Patient in chair, pale, clammy. She was responsive.  Reassurance given, waited 30 minutes. More patient education given verbally. Vitals checked.
On May 21st 2021 I suffered a cerebellar left hemisphere stroke resulting in a taxia on my left side. After repeated CAT scans MRIs echocardiograms including t e e there is no explanation for where the 40 to 50 lesions came from in my cerebellum.
Rash around injection site. Approximately 2" out from inj. site. No swelling, No erythema.
Weakness in lower extremities, progressively got worse over 2wks and also involving weakness in upper extremities over 1 wk. Diagnosed as AMAN -variant of GBS, started treatment with IVIG for 5 days.
Information has been received from a health professional concerning a child between the age of 6 and 8 yrs old who at 12 months old, was vaccinated with a 0.5ml, SC dose of varicella virus vaccine live. It was reported that the pt experienced breakthrough chickenpox with less than 50 lesions and if there was a fever it was very mild. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that she didn't recall any other information. Additional information is not expected.
Patient received first Pfizer COVID-19 vaccine. About 10 minutes after vaccine  was given, patient passed out. He was diaphoretic and unconscious. At one point, he respiration rate stopped, patient had very diminished, weak carotid pulse. Epi was about to be given and  patient started spontaneously breathing. Patient did not fall. Patient became conscious a few minutes later. He said he felt lightheaded and dizzy then he was out. Patient's wife said he has no allergies and not diabetic. He ate breakfast this morning.  Medical response was called to bedside. Vitals were taken. Medical response transported patient to ER. As patient was getting transported, he started to go in and out of consciousness again. Patient in ER at this time.
Fever to 101.9 and "rash", rash c/w with varicella, 50-75 lesions by 5/24/10 8 am; symptomatic care prescribed.
Client presented to local Covid Vaccination Site on 08/19/2022 for a Pfizer first booster. At 1026 nurse administered a Pfizer adult booster dose Lot# FP7138 on left arm. At 1040 nurse notified lead PHN that Pfizer adult dose was given to client instead of a pediatric Pfizer dose. Lead PHN spoke to the client and the client's mom in the observation area that a wrong Pfizer dose was administered and that a medical consult would be done to see if there was any further action needed. Client denies any symptoms at this time. Client's mother states no adverse reactions to Pfizer primary series, NKA, no medical history, and no medications taken at this time. At 1041 Lead PHN submitted a medical consult via text message to Dr. At 1041 Dr. replied with "No further action needed". Lead PHN communicated with client's mother that no further action was needed and educated client and client's mother to seek medical care if any adverse reactions occur and to contact their primary provider if anything changes. Lead PHN also educated client and client's mother that the client is up to date with Covid vaccines. At 1056 client reported she was feeling well and reported no symptoms to Lead PHN. Client and client's mother left the facility at 1057 after staying 30 minutes in the observation area in steady gate.
patient states she got a lump at injection site after vaccine was given. She checked with her doctor and they said it was ok, just to  watch it. Then she stated around Thanksgiving she developed an abscess below injection/back of her arm.  Then she just had to get it lanced before Christmas. She is till being treated
Injection site pain 7 days. Patient c/o joint pain states"fuzzy feeling", difficulty concentrating, congested sinus, dull head throb, and fatigue onset 24 hours after receiving vaccine.
11 doses were administered from 1 vial was that past the 30 day use by date in refrigerated storage; however was in refrigerated storage longer then 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 doses were administered from 1 vial was that past the 30 day use by date in refrigerated storage) and PRODUCT STORAGE ERROR (however was in refrigerated storage longer then 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 doses were administered from 1 vial was that past the 30 day use by date in refrigerated storage) and PRODUCT STORAGE ERROR (however was in refrigerated storage longer then 30 days). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (11 doses were administered from 1 vial was that past the 30 day use by date in refrigerated storage) and PRODUCT STORAGE ERROR (however was in refrigerated storage longer then 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. Number of doses/vials are 11 doses administered from 1 vial. Nurse states 8 doses were 0.25mL booster doses and 3 doses were 1st primary series Moderna dose.
This all occurred the evening  she received the Janssen vaccine. Reported burning feeling in back along spine and over both scapula. Diaphoretic . Noticed  a bit of a red rash on back that looked like "pimples". Two days later noticed red streak under left armpit and painful to touch along with some swelling.  (not sure if this is still there) Did not miss work due to these side effects.
Received vaccination 6-8. On 6/10/10 MD noted rash on ( L ) leg - child has c/o of itching. KINRIX & Varicella given ( L ) thigh area not hot to touch but rash is a raised & blotchy. Approximately 1 in below on injection site that is redden 1/16" around it. No increased temp. Injection site blotchy rash 3 cm x 3 cm in L shaped pattern. Other injection site not noticeable band-aids were used. Nothing ( R ) thigh. Mother reports redness was gone on upper left leg by 12:30 p.m. Saturday, 6/12/10 and the bumps were completely gone by Saturday evening, 6/12/2010. The skin has brown, splotchy discoloration the same dimensions as on 6/11/2010 with no complaints of fever. The area never itched per mother's report. There are no raised bumps present today on 6/14/2010.
Abnormal Pap smear 1/31/2018 with mild dysplasia and with HPV 18/45 positive on this date.