chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information of this prospective pregnancy report has been received from a 33 year old female pharmacist referring to herself. The patient had an anaphylactic reaction to cephalosporins. The patient became pregnant with Last Menstrual Period of approximately 04-DEC-2014. On 12-MAR-2015, at the patient's 14 weeks gestation while she was injecting the diluent in the syringe into the vial of ZOSTAVAX, lot # K023624, exp. date 19-FEB-2016, the diluent splashed into her eye and her face. There was no concomitant medication. The pharmacist stated that her eyeball was "red" on 12-MAR-2015. She used "eye wash" as a treatment for the event. The Estimated Date of Delivery was approximately 10-SEP-2015. The pregnancy outcome was pending. There was no lab diagnostics studies performed. The outcome of event "red" eyeball was unknown. The patient did not seek any medical attention. Additional information has been requested.
Narrative: Patient reports history of guillain-barre syndrome post flu vaccine; no othe rdetails provided
Client said at about 9 PM on 8/19/2022, he started getting chills, headache, fever, delusional, and had a hard time walking. Client went to the ER due to fever at 103, O2 was reported to be less than 90%. Client stated the ER told him it was probably to do with booster dose, and treated him for a headache. Client states that he is still having headaches, and slight fever and chills, and still feels run down.
Pain in non-vaccinated arm (Right Arm)/like he has been hit with a 20 lb brick; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The case was received on afterhours voicemail box. The pharmacist reported that the patient was vaccinated with Shingrix vaccine in left arm but patient was reporting that his right arm was sore, like he had been hit with a 20 lb brick. No additional details at time of reporting. The reporter consented to follow up.
Initial misuse report received from a healthcare professional on 24 October 2013 and at GPV on 21 March 2014. A male patient of unknown age received FLUZONE and then realized that the patient was vaccinated a week ago. The patient received an extra dose. No adverse event was reported. The list of documents held by sender: None.
Eight days after MMR, VAR, IPV; patient had low grade fevers and erythematous morbuluform rash head to trunk LE/UE; palms and soles.
Patient was experiencing the following symptoms at 10:45pm- vomiting, extreme nausa, severe headache and backache, very high temperature, awful chills-whole body vibrating and coughing. Went to ER at 11:15pm and discharged at 4am. ER doctor did find a low grade pneumonia and UTI but felt all the symptoms started with the vaccine in his opinion and caused a domino effect. He also said not to get the second shot and to review this with her PCP.
heart palpitations, heart palpitations change randomly; shortness of breath; low blood pressure 99/60; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations, heart palpitations change randomly), DYSPNOEA (shortness of breath) and BLOOD PRESSURE DECREASED (low blood pressure 99/60) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (heart palpitations, heart palpitations change randomly), DYSPNOEA (shortness of breath) and BLOOD PRESSURE DECREASED (low blood pressure 99/60). At the time of the report, PALPITATIONS (heart palpitations, heart palpitations change randomly), DYSPNOEA (shortness of breath) and BLOOD PRESSURE DECREASED (low blood pressure 99/60) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 99/60 (Low) 99/60.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
8/21/13 - Heache and arm twitching episodes, 40 min to 2 hours in legnth. Neg EEG. Diagnosed with pseudoseizures. See neuro notes. 10/1 - Present - Abd pain - see 2 x ER notes.
4inch in diameter raised red area around injection site, warmth and hardness to site. States it does itch Employee has no other complaints associated with site or health.
Initial report received from healthcare professional on 13 December 2013. A patient (age and gender unknown) whose medical history and concomitant medications were not reported received PENTACEL (lot number and expiration date were not reported) (site, route and dose number not reported) on an unknown date. On 06 October 2013. The nurse reported that PENTACEL powder was mixed with sterile water and DTaP/IPV not given. Sterile water for injection No clinical data on the use of other diluents than what is licensed with the vaccine. It is the opinion of our Medical Director that use of sterile water or 0.9% NS might lead to dissociation of the protein-polysaccharide conjugate. In the absence of clinical data showing that normal immunogenicity is retained using these diluents, we cannot support this practice. Discard DTaP/IPV and give a properly reconstituted dose of PENTACEL. Chart lot numbers appropriately. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Patient had rash throughout lower abdomen - Rash were pinpoint flat and red. 15 minutes later rashes hot to both inner wrist and inner feet and ankles. Patient also complained of slight itchy throat after 30 minutes of being monitored. Hive with itchy throat resolved and rash did not progress further during the time of monitoring.
Left deltoid - "redness and swelling of the left shoulder, down to about the mid-upper arm"   No fever.  Happy, playful, eating and drinking normally.   Mother applied ice pack
Narrative:  Blood clot following COVID vaccine dose #1 06/11/2021 COVID (Moderna) vaccine dose #1, received at location; was scheduled to receive second vaccine dose July 9 06/24/2021 Seen in urgent care for calf pain, told he pulled muscle, received ketorolac, wasn't helpful 06/25/2021 RN calls pt to determine reason for new appt on 6/28, pt reports 'worsening pain to R leg/calf x 5-6 days' 06/28/2021 Pt seen by PCP c/o '7-day h/o new onset 4/10 sharp R calf pain upon awakening that is spreading upward. Pain is worse with walking and relieved with rest. BLE elevation, ice application, heat application, and stretching calf all not helpful. He reports he went to urgent care 4 days ago, reportedly was told he pulled a muscle, no U/S, he received Toradol injection and another unknown injection that caused him to feel drowsy (both not helpful).' Ddx: muscle strain; labs ordered; D-Dimer elevated 06/29/2021 Seen in hospital dx'd with 2 superficial blood clots at some point after COVID vaccine dose #1. One was in the Gastrocnemius vein and the other in the Lesser Saphenous vein; was advised against receiving second vaccine dose
10/25/03 Came to immediate care. Received influenza and pneumonia vaccine 10/23/03; both in left upper arm. On 10/25 came to IC with complaints of redness, pain, 9cmx14cm area of erythema. Slight tender axillary lymphadenopathy. Given keflex 50mg QID for 7 days. On same day of influenza/pnuemonia; got Td in other arm (left); no complaints. Had initial pain at injection site, but on 10/25 developed redness and increasing pain. Vaccines given at her PCP; reaction on weekend so came to I.C.
dizziness 15 min after vaccine, called patient, only sore arm now, will follow up with PCP if any other symptoms
Narrative:  Patient was seen again after administration of the 2nd dose. She again developed her typical migraine ~10 minutes after administration. This was described as an ice-pick, concentrated over the left side of her head and some associated left-sided ear fullness. She was placed in an examination room where the lights could be turned off to a/w photophobia. On examination: Gen: non-toxic, not in distress, answering questions appropriately, pleasant HEENT: atraumatic/normocephalic, PERRL, nares patent, throat non-erythematous/no exudate, no swelling. B/l ear canals with cerumen, non-impacted Neck: no swelling CV: regular rate and rhythm, normal S1/S2, no murmurs Pulm: clear to auscultation Ext: moves all 4 spontaneously, no edema Skin: no lesions or rashes Neuro: CN II-XII grossly intact, 5/5 b/l grip strenght Psych: appropriate, thoughts linear A/P: migraine s/p 2nd vaccination, similar timeline to first vaccination.
First, I felt like I had just caught a cold. I got very congested. I had no energy and felt very lethargic and sleepy. I had just had a sinus infection so I thought it was leftover symptoms from that. I decided to take an at-home COVID-19 around 12/28/2022 after coming home from our trip, and it came back positive. I called my doctor the next morning who prescribed me Paxlovid and an antibiotic for my sinus infection. After days of resting and taking treatment, I began to feel better and recovered.
pt devel sx of measles w/Koplik's spots following vax w/MMR; no details were provided;
Positive Covid 19 diagnosed on 1/19/2022 Symptoms started 01/17/2022 with a chronic cough then head and some chest congestion, runny nose, headache. Head congestion became increasingly worse over following two days.
Adverse reaction to influenza vaccine. Induration of injection site 4cm diameter. Redness, induration of 2.5cm; tender to palpitation. Fever, chills.
FLUBLOK administered to pediatric patient with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA402707(CLUSTER), 2022SA402396(CLUSTER), 2022SA402443(CLUSTER), 2022SA402500(CLUSTER), 2022SA402436(CLUSTER), 2022SA402514(CLUSTER), 2022SA402525(CLUSTER), 2022SA402505 (CLUSTER), 2022SA402662(CLUSTER), 2022SA402704(CLUSTER), 2022SA402707(CLUSTER), 2022SA402964(CLUSTER), 2022SA402510(CLUSTER) and 2022SA402530(CLUSTER).  This case reported  a 7 months old female patient and it was reported that Influenza Quadrivalent Recombinant Vaccine [Flublok] administered to pediatric patient with no reported adverse event .   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A). On 12-Sep-2022, the patient received suspect Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation unknown) (lot UJ887AA, exp date: 09-Jun-2023) standard strength, via intramuscular route in the left deltoid for immunization at 7 months of age with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  On 12-Sep-2022 the patient was administered with flubok with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  No lab data was reported  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event  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 the 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.
sore arm; temperature; chills; body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (temperature), CHILLS (chills) and MYALGIA (body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (temperature), CHILLS (chills) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (temperature), CHILLS (chills) and MYALGIA (body aches) had resolved.            No concomitant medications were provided.  No treatment information provided.
This initial non-serious spontaneous case was received on 30-Oct-2017, from a pharmacist, concerning a female pregnant of unspecified age. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). It was reported that, the pregnant woman was administered with flu vaccine and has enrolled in the flu vaccine registry.
Patient had elevated blood pressure affecting pregnancy. Her cesarean section due date was moved up from 3/22 to 3/10. Per notes from Doctor on 3/10/21: Estimated Date of Delivery: 3/28/21 who presented for repeat C/S at 37 wks due to GHTN. Her BP's did normalize following delivery and she did not require antihypertensive medications. Procedure was uncomplicated as was her postoperative stay. Baby did get admitted to NICU and is doing well.
Swelling and redness and pain and tenderness at vaccine site right arm followed by fever, myalgia, malaise, URI symptoms and increased swelling and pian, weakness, dizziness bringing her to the ER.
Body aches, fever 100.7  3/11/21 starting 9 a.m. Tylenol relieved symptoms; Slept until 4 p.m. Aches and fever came back. Took Tylenol at 9 p.m. Morning of 3/12/21  felt tired but no fever or aches By p.m. felt fine
First 24hrs post injection fever, nausea, vomiting and extreme irritability; Symptoms persist for 72hrs and revisit idiopathically >4 months; Speech regression withdrawal with minimal tone verbal communication. Speaking prior to event!
Very soon after the shot, I felt a slight warming/burning sensation in my throat and chest. After a few minutes, I realized it felt like acid reflux, which I get occasionally.
Fever-102, chills, body aches, arm soreness, headache, mail aide Began approximately 3-4 hours post injection and lasted all next day.  Third day symptoms of head cloudiness and lightheadedness.
Low grade fever, swollen shooulder, swollen wrist and hands, headache, neckache arm pain
Generalised Hives/urticaria; Generalised erythema/redness; Rash from each elbow to each hand/rash; Generalised Itching/pruritus; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Generalised Itching/pruritus), URTICARIA (Generalised Hives/urticaria), ERYTHEMA (Generalised erythema/redness) and RASH (Rash from each elbow to each hand/rash) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013m20a and 026A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PRURITUS (Generalised Itching/pruritus) and RASH (Rash from each elbow to each hand/rash). On an unknown date, the patient experienced URTICARIA (Generalised Hives/urticaria) and ERYTHEMA (Generalised erythema/redness). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency; HYDROXYZINE on 01-Mar-2021 for Rash, at a dose of 25 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) on 01-Mar-2021 for Rash, at a dose of 25 milligram and FLUOCINONIDE (FLUCINONIDE) on 27-May-2021 for Rash, at a dose of 0.5 percent, ointment. At the time of the report, PRURITUS (Generalised Itching/pruritus) and RASH (Rash from each elbow to each hand/rash) had not resolved and URTICARIA (Generalised Hives/urticaria) and ERYTHEMA (Generalised erythema/redness) outcome was unknown.            Treatment medications include: On 01-MAR-2021 : anti-itch lotion 0.5 percent, steroids-0.5 mg 2x daily and steroids stopped on 10-MAY-2021 On 25-05-2021 Laboratory test include teledermatology and issued ointment. Concomitant medications were not provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Significant follow up includes reporter details , patient information, drug information, events , treatment medication details were added
rash on the right thigh, red, warm to the touch it started the size of a silver  to taking up almost her whole right thigh. Pt has not complained of any pain at the site. Treatment Mupirocin 2% topical ointment and Hydroxyzine HCL 10mg/5ml oral solution
In less than 15 min pain in shoulders, moved to other shoulder, 10/25/06 weak and hurt in shoulders and arm all day, missed work- use ice/heat- motrin.
Pt received first dose on May 14. Initially, we did not think side effects. Pt did complain of getting dizzy when standing up, but we did not think was related. We thought it was from her methotrexate. Pt received her second dose on June 6. On June 7, Pt had chest pain, tachycardia, and did not feel right. We went to Hospital. Pt was admitted because of the high pulse rate and nausea and vomiting. It appears that the vaccine triggered POTS.  This is an update to my report that I filled out in the hospital a few days ago
I received the the first dose of the COVID vaccine on Friday, 4/23/21. On Sunday evening (4/26), my menstrual  cycle started, even though I just had my last period the week prior. My cycle varies as I'm in peri-menopause but I've never had two cycles a week apart before. Also, my normal cycle is normally moderate amount of bleeding the first day and then cuts off drastically (spotting mainly) for the next 2-3 days. I am on day 3 today and the amount of bleeding has been heavy since it started Sunday evening. The color is also very bright red (where normally it is more of a dark rust color).   I am not experiencing any cramping at all or any other pain, just abnormally heavy bleeding.
pt to ED with altered mental status, swollen abdomen, urinary incontinence; had a previous hospitalization with hepatic encephalopathy, no lactulose given; spoke with PCP and he advised him to go to ED when arrives back home; positive test for COVID; asymptomatic; pt was found unresponsive in the bathroom and pulseless; CPR x 3; ROSC obtained; transferred and intubated; hypotensive; vasopressors; family updated with pt's condition and the decided to make him a DNR; pt died in the hospital
Raised, red, itchy, painful, swollen area approx. 4 1/2in x 3in today. Area has tripled in size since yesterday.  Area is warm to the touch.  Has been getting Motrin, Benadryl, and Zyrtec at home. Pt. has no appetite and decreased energy level. Low grade temp of 99.5 last night. Has Dr's appt today.
1 inch firm tender swelling at injection site, not warm at 1 week post injection. Resolved by 2 weeks.
35mm red, warm, raised area over HIB inject site; t103 2 days ago; MD did sp tap-neg for meningitis; Pt is now cutting teeth (reported by mom) advised pt's mom that if induration does not dec or it worsens pt should see MD:
Dizziness, Lightheaded, Low blood pressure, low blood sugar every day from 9pm-noon.
Modern a was given as first dose, and Pfizer was mistakenly given for their second dose
Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients received improperly stored ROTATEQ (lot# K001935, expiration date: 08-DEC-2015, lot# reported as K023537, expiration date: 22-JUN-2016, oral, dose was unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician assistant concerning her 17 year old niece who on an unspecified date, was vaccinated IM with GARDASIL (lot# not reported) at another physician's office. Subsequently the patient experienced heart palpitations. Subsequently, the patient recovered from heart palpitations. The patient sought unspecified medical attention. Additional information has been requested.
bradycardia, agonal breathing, chest pain, palpitations, fever, headache, chills, body aches
Seven hours after receiving Pneumococcal Polysaccharide Vaccine (PPSV23) in the upper third of my left deltoid, I developed severe pain (9 out of 10) and marked limitation of left shoulder range of motion (e.g. couldn?t raise my arm laterally >8 inches from my body without severe pain, waking me from sleep. With acetaminophen and applying ice to my shoulder every 3 hours, the pain decreased to mild pain (2 out of 10) in one week and has improved to very mild (1 out of 10) intermittent pain ?three weeks post-vaccination.       As I am a physician, I reported my subacromial bursitis to my physician - and requested that the nurse be trained to administer vaccines in the mid-deltoid region.
approximately thee days post vaccination, the patient experienced dizziness, fatigue, fever, sore throat,"stuffy" head ans some coughing. these symptoms lasted three to four days.
Resident had a pre-syncopal episode. Was sent to the ER, returned home the same day at baseline with medication changes.