chrisvoncsefalvay/vaers-outcomes huggingface dataset:
client states, she woke up to hives to middle of neck to belly button and down her entire back.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 58 year old female with not ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included: non-smoker and non alcoholic. The patient has no known allergies. The patient does not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number:1805020 and expiry: unknown) 1 total, dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination (Dose number in series 1).  No concomitant medications were reported.  The patient received booster of covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1855190 and expiry: unknown) 1 total, dose was not reported, administered at left arm on 12-JAN-2022 for prophylactic vaccination (Dose number in series 2).  On 15-JAN-2022, the patient tested positive for Covid-19 using home rapid test (Dose number in series 1). The patient has not sought medical treatment.   The patient had not recovered from covid-19 test positive. This report was non-serious. This report was associated with a product quality complaint: 90000211983.
Client fully vaccinated for COVID-19 tested positive for COVID-19 on 7/10/2021. Vaccine Dose #1 given 2/27/2021. Vaccine Dose #2 given 3/20/2021. Client hospitalized on 7/14/2021 for shortness of breath, cough, confusion, and severe generalized weakness. Client died on 7/17/2021.
Narrative: An error occurred while administering the Moderna Bivalent booster on 10/05/2022. Patient was given .25mL instead of the full dose of 0.5mL vaccine.Patient was retrn to facility for an addition.25mL dose on 10/06/2022
I felt a localized area of pain in my left underarm, about the size of a quarter. It was there upon waking in the morning on Tuesday and Wednesday, July 20 and 21. It went away a few minutes after getting up for the day, each day.  I called my doctor and did a telehealth appointment with her, describing the symptoms. She told me axillary nerve pain was a potential adverse effect of my Moderna covid vaccine. No treatment was given, since the pain did not continue past Wednesday, July 21.
the patient experienced a rash all the way around her left arm down to her elbow; patient was seen in the office on 08-OCT-2019 for an unspecified reason; This spontaneous report was received from a medical assistant via company representative, referring to a 70-year-old female patient. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were unknown.     On 09-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in left deltoid for prophylaxis (strength and dose were not reported, lot number S009238 has been verified to be a valid number; and expiration date 11-FEB-2021).   On an unknown date, the patient experienced a rash all the way around her left arm down to her elbow. The patient did not seek medical attention, the rash lasted a couple days and was resolved on an unspecified date..  It was also reported that on 08-OCT-2019, the patient was seen in the office for an unspecified reason (adverse event). The outcome for of adverse event was unknown. It was reported no treatment was given to the patient nor laboratory diagnostics or studies was performed.   The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administration, and the events was not reported.
10/02/2014 to 10/03: soreness at injection site (arm). 10/04: gradual throat swelling; viscous saliva developing, malaise, no fever. 10/05: moderate congestion; runny nose; severe malaise. 10/06: symptoms resolved but then evening severe chills with shivering 12 hours.
After shots, client went to work, sat down, experienced sleepiness.  Went home - did not work, went home, slept for several hours and felt better.  Felt well next day - state had applied a therapeutic patch for back pain before shots and had not used one for 3 weeks.  Client states she thinks the patch was responsible for the episode.
inj site red & warm;site hard & painful;11OCT97 seen in walk-in care; dx allerg rxn vs infect;ATB given;
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient felt dizzy and asked to lay down. Had patient lay down on the ground and monitored patient. Asked if she needed EMT/911, patient declined. Patient then asked pharmacy to call 911. Patient was taken to ER and tests were ran. Physician said patient had an adverse reaction, but would not call it an allergic reaction. Patient had no anaphylaxis. Patient showed up back to pharmacy to pick-up card and finish report.
On 01/05/2021 I had urinary trac symptoms with frequent urination and pain.
Patient presented to Emergency Department approximately one week after receiving SHINGRIX vaccine with fevers, now has shingles along T1 dermatome.
sore upper arm at site of shot, 100.8 fever, shivers/chills
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient's medical history was not reported. On an unknown date the patient was vaccinated with VAQTA (dose, frequent and route were unknown) which was improperly stored. Concomitant medications were not reported. Medical assistant confirmed that VAQTA was administered according to the dose and route recommended in the prescribing information. No adverse effects were reported. No product quality complaint (PQC) was reported. This case is linked to case # 1407USA000032 (same reporter link). Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of postnasal drip in a male patient who received SHINGRIX. On 26th March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced weird feeling and chills. On 26th March 2018, the patient experienced postnasal drip and dysgeusia. On an unknown date, the outcome of the postnasal drip, dysgeusia, weird feeling and chills were unknown. It was unknown if the reporter considered the postnasal drip, dysgeusia, weird feeling and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Almost right away after receiving SHINGRIX the patient developed a post nasal drip with a medicine taste in his mouth. The patient had also been feeling chills and felt weird.
Administered ZOSTAVAX about 10:49 am. Pt came back to pharmacy about 10 min later, (I asked her to wait in store for 15 min after vaccine before leaving) she said her throat was tingling and so were her lips & tongue. I monitored her for a few more minutes, she said it felt like her lips were swelling & she could barely swallow. I immediately called 911 & monitored her until help arrived.
Patient was administered a dose of the monovalent COVID-19 vaccines after they were no longer authorized. Patient was notified and stated he did not have any symptoms.
Shortly after receiving my 2nd COVID shot on 2/22/21, (first was 1/21/21) I started to experience constant pins and needles in my right foot/calf.  Since that time, it has progressed to  my whole body.  I had my first booster 11/1/21, and my second 10/3/22.  I have seen a neurologist at local Hospital who diagnosed me with Small Fiber Neuropathy.  They have tried courses of pain medications, to no avail.  It?s not pain - it?s constant pins and needles.  They are scheduling me for a skin biopsy.  I had an EMG and CT scan.  I am convinced it is related to the vaccine, although I understand research is in its early stages.
@ 1:12 pm, patient is sitting on the chair , twinrix and flu vaccine was administered. Right after receiving the vaccine, patient stated "I feel dizzy". LN responded quickly and CODE BLUE was paged overhead. Another staff responded quick and came in the immunization room and helped assessed the patient. Placed patient on a lying position with both legs elevated . VS BP 112/57, HR 52 ,02 sat in RA 98%. Cont. to monitor.  @ 1:15 pm, multiple staff came in to help assessed the patient. Patient still in a lying position with both legs elevated. VS: BP 128/76 ,HR 51, 02 SAT 99% RA.  @ 1:18 PM, patient stated " I feel 100 % okay". Alert and verbally responsive. No c/o dizziness, no pain or discomfort. No difficulty breathing. Staff was still cont.  monitoring the patient.VS: BP 112/57, HR 57, , 02 SAT 98% RA. @1:20 pm, patient stated " I feel okay". No dizziness, no pain or discomfort. Advised patient to stay for another 10 minutes to be monitored. Also advised patient to f/u with his PCM for further eval. regarding what happened today. Patient stated understanding with no further questions at this time.
Patient had a rapid heart beat for 30 minutes about 4 hours after vaccination. Referred to physician or local  ER
DTaP-IPV fluid had not been administered to the patient; Initial information regarding an unsolicited valid non-serious case was received from a Other health care professional via Agency (Reference number- 00374983) and transmitted to Sanofi on 30-Nov-2020.  This case involves a 6-months old female patient who received PENTACEL  (Batch number UJ349AAA, expiry dates 22-Jun-2021) via an Intramuscular route in an left leg (left thigh) for prophylactic vaccination, on 23-Nov-2020. The reporter said, It was later discovered that the DTaP-IPV fluid had not been administered,(Inappropriate reconstitution technique).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patients concomitant medication includes flu vaccine (ROTAVIRUS VACCINE, Batch unknown and expiry date not repoted).  It was an actual medication error due to Inappropriate reconstitution technique (Latency 1 day)  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.
Shakes, chills, elevated temperature - lasted 24 hours, forehead pressure, temple pain - lasted 48 hours
headache; muscle ache; tiredness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2021, the patient received the 2nd dose of Shingrix. In July 2021, less than a week after receiving Shingrix, the patient experienced headache, muscle pain and tiredness. On an unknown date, the outcome of the headache, muscle pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself/herself. The patient reported that after dose of Shingrix he/she experienced headache, muscle ache and tiredness. The patient inquired how long the side effects would last. No other information was provided.
Pass out/fainted, we had call 911, when EMS arrived and checked BP = 137/89, glucose = 98. Pt was normal by that time and patient decided to go home and decline any further assistance from EMS.
nausea, "feels like going to pass out". Evaluated by EMS-Refusal to transport.
I felt great until the end of May until the bones in the top and inside part of my feet started hurting. 2 weeks later I started having jaw pain and it made it almost impossible to open my jaw. These symptoms are still happening. I have never had any joint pain ever. On 06/22/2021 I went to clinic for the pain and I was coughing as well, they told me to put compressions on my feet and they did not do any medical tests for the jaw or feet. They just gave me some medications for the cough. They just did a Covid test which was negative.
pt recvd vax & not inc liver enzymes (SGOT/SGPT) in 1992;pt has no sx;liver enzymes cont to be elevated,& pt is having this condition evaluated by a MD;pt's concern has been prompted by a relative who required a liver transplant
knotted up my neck within seconds; 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 61 year-old male patient received bnt162b2 (BNT162B2) (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: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "knotted up my neck within seconds". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021428188 Same reporter/ drug/ event for different patients.
low grade fever, body aches and chills, 24 hours, acetaminophen and Ibuprofen
Day of vaccine- Headache, sore arm, nausea, Fatigue Day following Vaccine: Periods of feeling great then chills and slight fever Night Following Vaccine: Chills, headache, slight fever 99.9, fatigue  2day post vaccine: Busted capillaries on same arm as injection site. No other areas of busted capillaries spotted on body.   7day post vaccine: Slight tingling and numbness of left side of face. No other medical changes have been made since vaccine.
I got a case of shingles on the right side of my face and head that included my right eye.  I almost lost the sight in my eye, and missed almost 12 weeks of work.  I was treated by an eye specialist for weeks.  Dr. and the eye team agreed that the flu vaccine triggered shingles.  I was perfectly healthy at the time of the vaccine and rarely get sick.   I did receive a flu vaccine a few years earlier (2008) and got a case of bronchitis the developed into pneumonia.  I was perfectly healthy before that vaccine also.    I just learned that this could have been reported.  I'm not sure it was ever reported.
Patient was ok 15 minutes after vaccination on 4-8-21 (Thursday) .  On 4-10-21 Saturday but start to feel headache, body aches , chills , no appetite, unable to get out of bed, fever .  Today 4-13-21 Patient has swelling in her legs and chest tightness.  Recommended the patient to go to the hospital.
received a double dose accidentally; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (received a double dose accidentally) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (received a double dose accidentally). At the time of the report, ACCIDENTAL OVERDOSE (received a double dose accidentally) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided. Reporter enquired what if she received a double dose accidentally.
soreness in the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the injection site) 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 SITE PAIN (soreness in the injection site). At the time of the report, VACCINATION SITE PAIN (soreness in the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that Adverse Event is getting worse  Concomitant product was not provided by the reporter  Treatment information was not provided   Reporter did not allow further contact
No adverse event; Patient received a 0.25 ml (25 mcg) dose as booster from booster dose only presentation vial with a volume of 0.25 ml instead of 0.5 ml (50 mcg).; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml (25 mcg) dose as booster from booster dose only presentation vial with a volume of 0.25 ml instead of 0.5 ml (50 mcg).) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml (25 mcg) dose as booster from booster dose only presentation vial with a volume of 0.25 ml instead of 0.5 ml (50 mcg).). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml (25 mcg) dose as booster from booster dose only presentation vial with a volume of 0.25 ml instead of 0.5 ml (50 mcg).) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a 0.25 ml (25 mcg) dose as booster from booster dose only presentation vial with a volume of 0.25 ml instead of 0.5 ml (50 mcg).).    No concomitant product use was reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was unknown.
Patient mother noticed small nickel size lump on the Left thighs on 4-27-23. Mother denies giving any OTC medication at the time. Mother states child continued to play as normal. Next day on the 4-28-2023 mother saw lump was now red and larger. Mother then called clinic to notify us of the possible reaction. Mother was brought in to the clinic for further evaluation. PCP did confirm reaction to Kinrix. child was administered 10 ml of Benadryl in Clinic. Mother was sent home with child to further monitor.
Fatigue/weakness; h/a; fever, nausea & diarrhea; sweating; achiness; sensation of warmth; light headedness; chills; flushing; (12 hrs duration); abd pain/cramps (1 wk duration); achiness; (2 wk duration); fatigue; (one month duration);
At approximately 3-4 minutes after vaccination patient complained burning pain in her arm.  Mom notified RN.  RN evaluated.  Left arm red from shoulder to wrist.  Her left arm was hot to the touch.  Cold water bottles and then ICE applied to her arm.  Mom instructed to call PCP.  Mom put a call into PCP. RN noticed patientss chest becoming red.  Paramedic requested to evaluate.  The RN administered 50 mg PO Benadryl per standing order. By 7:35 pt. arm starting to appear less red and pt. reported less burning sensation.  Mom reports pt is doing fine this morning.
fatigue; chills; Fever of 105F; severe pain in the arm; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (severe pain in the arm), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (Fever of 105F) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (severe pain in the arm). On 22-Jan-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills) and PYREXIA (Fever of 105F). At the time of the report, PAIN IN EXTREMITY (severe pain in the arm), FATIGUE (fatigue), CHILLS (chills) and PYREXIA (Fever of 105F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 105 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Initially with sinus congestion pressure, nasal discharge ear pain progressing into low back pain with paresthesia L > R legs, then she was unable to ambulate. Initial symptoms on 10/8/09 were treated with AUGMENTIN.   11/2/09 Hospital records and discharge summary received service dates 10/20/09 to 10/31/09.  Assessment: Signs and symptoms of atypical Guillain-Barre syndrome with lower extremity weakness. E. coli urinary tract infection. Multilevel spondylosis resulting in central stenosis at L3-4 and L4-5. Left posterolateral disc herniation accentuating the central stenosis and impinging the thecal sac. Far right lateral disc herniation at L2-3. Central disc herniation at T11-T12. Diabetes mellitus. Anemia of chronic illness. COPD. Transient elevation of liver function testing. Hypothyroidism.  Patient presented with diminishing reflexes along with progressive decline in her ambulatory ability. Unsteadiness, trouble raising left arm. Left-sided low back pain which radiated down left leg. Diminshed reflexes lower extremities. Upper thigh decreased sensation to light touch. Hematuria and urinary frequency. Insomnia, nausea.  ``11/5/09 Received Urgent Care medical records for 10/20/09. FINAL DX: lower extremity myalgia & weakness, r/o Guillian Barre syndrome Records reveal pt experienced progressively worsening low back pain w/aching radiating to bilateral legs w/weakness x 5 days, difficulty walking, near falls, difficulty standing from sitting.  Reflexes decreased bilaterally.  Sent to ER for further investigation & probable admit to hospital.  11/20/09 ED notes received service date 10/20/09. Assessment: Paresthesias in lower extremities, weakness. Pain in both hips and legs. Unable to get up from chair unassisted. Difficulty walking. Admitted for further evaluation.
Pt experienced swelling of arm at injection site, fever, joint pain, cough for a week.