chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: Caller (reporter) wanted to get her 10-year-old son vaccinated with Covid. Caller wanted to know when it being approved for under 12 years old, was there a Covid trial she could get her son into. She added her parents, her husband and herself all got the Pfizer Covid vaccine and none of them had any problems other than a sore arm for just a couple of hours.      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-202101031454 same reporter/drug/event, different patient.
Nausea that lasted all day on Tuesday,  January 26th Thobbing pain behind my right ear, lasting 2 days.( started Tuesday and continued through Wednesday)
Bleeding upon withdrawal of needle, soreness at injection site, soreness of injected left arm, stiffness of injected left arm.
My left eye lid has been twitching intermittently for 3 days. I never had this prior to receiving the vaccine.
feeling sick; feel like I got the flu; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick) and INFLUENZA LIKE ILLNESS (feel like I got the flu) 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 MALAISE (feeling sick) and INFLUENZA LIKE ILLNESS (feel like I got the flu). At the time of the report, MALAISE (feeling sick) and INFLUENZA LIKE ILLNESS (feel like I got the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment was not provided.
Pt's 2nd dose of J&J - Booster. Pt received booster vaccine at 0900.  At 0907, the pt called out to the nurse and said he was not feeling well.  Pt was pale and diaphoretic. EMS was initiated.  Reclined pt back in his seat.  Applied col pack and gave water.  Vitals taken.  BP-138/90, HR-92, 02 sat @ 96%.  EMS arrived at 0915.  Pt stated he was feeling better.  Pt declined being transported to hospital.  Pt observed for an additional 20 mins.  Pt reassessed and was alert and oriented; skin was warm and dry.  Pt verbalized he felt fine.  Pt driven by family friend to his home.  Total observation time was 35 mins.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (unspecified lot # and expiry date: 18-JUN-2016). Medical assistant reported that the vaccine underwent temperature excursion on unknown dates with following details: unspecified lot # (exposed to 31 and 49 degree Fahrenheit for unknown time frame, 31 F for 1420 hours and 49 F for 700 hours, respectively). No adverse effects were reported. This is one of the four reports received from the same reporter. Additional information has been requested.
PATIENT RECEIVED SHOT AND DURING HIS 15 MINUTE WAIT TIME, HE SAID HIS BODY FELT VERY RELAXED AND HE URINATED ON HIMSELF. HE SAID THIS HAS HAPPENED IN THE PAST WHEN RECEIVING SHOTS AND STATES HE DOES FEEL UNEASY AROUND NEEDLES.
This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of vaccine exposure during pregnancy in a 41-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. On 14 January 2014 the subject received a dose of BOOSTRIX (1 unknown dose with notation of "5-2.5-18.5" and the meaning was unclear, intramuscular, unknown site) and experienced vaccine exposure during the 3rd trimester of pregnancy. The gestational age at the time of vaccination was approximately 28 weeks. The date of last menstrual period was 26 June 2013. The estimated date of delivery was reported as 2 April 2014 per the nurse. There was no evidence of defect from prenatal testing. At the time of reporting, the pregnancy was ongoing. Follow-up information was received on 15 April 2014 via healthcare professional. The pregnancy consisted of one fetus and was not by in-vitro fertilization. The subject  was at 28 6/7 weeks gestation at the time of vaccination with BOOSTRIX. At the time of the report no other information was provided. Follow up was received from a nurse on 27 May 2014. The nurse reported that there was no in-vitro fertilization utilized in this pregnancy. The nurse also reported concurrent medications included SYNTHROID. No further details were provided at the time of reporting. Follow up was received from the nurse on 11 August 2014. The nurse confirmed the information as it was previously reported. No details regarding the outcome of the pregnancy were provided. The pregnancy was marked as lost to follow up.
Pain along lower spine, bilateral Achilles? tendon and bilateral heels.  Decrease mobility.
Immediately after receiving DTaP and IPV, infant held breath when crying. After shaking arm, baby cried then stopped breathing again. Called MD in clinic started CPR and had 911 called by another nurse. Baby breathed on own after approximately 2 minutes. Rescue squad transported infant to hospital. History-prior apnea episodes documented in new born nursery.
Patient was in clinic parking lot post observation after first dose of covid vaccine when he decided to return to the clinic for what felt to him as "burning sensation" to back of neck and head.  Patient was observed to have raised reddened spots behind neck and on scalp(patient is bald).  Patient was also observed to have reddened spots on his back--but patient was unsure if those were there prior to vaccine.
This is a spontaneous report received from a contactable nurse via sales representative. A patient of an unspecified age, gender and ethnicity received TRUMENBA intramuscularly in the thigh area on an unspecified date at 0.5 ml, single for immunisation. Patient medical history and concomitant medications were not reported. After receiving the vaccine on unspecified date, the patient experienced a large red, hot, swollen, tender and painful area on the thigh where the vaccine was administered. Outcome of the events was unknown.
Painful, enlarged lymph node in axillary area on same side of injection (left), ibuprofen for pain, still painful and enlarged at time of submission
This case was reported by a pharmacist via call center representative and described the occurrence of painful rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced painful rash and vesicular rash. On an unknown date, the outcome of the painful rash and vesicular rash were unknown. It was unknown if the reporter considered the painful rash and vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that six patients have developed a painful skin rash that resembles Shingles, after receiving the SHINGRIX vaccine. The reporter did not consent to follow-up. The healthcare professional did not have patient information available at this time. This case was 1 of the 6 cases, reported by same reporter.
Itchy rash on arms, legs and torso with multiple raised, scaly lesions. Patient is dark skinned and redness was not noted.  Concentration of lesions at vaccination site.  Appeared within 48 hours of vaccination.  Previous two Anthrax vaccinations in the series also produced a similar rash but were not as extensive.  Patient was prescribed Diphenhydramine 25mg.
Dizziness where world is spinning around, blurred visions, ringing in ears, sees purple dots that began after 2nd dose of GARDASIL.
Headache, Sedation, Myalgia, Fever, Redness/Swellin/Itching @ injection site, Swollen lymph nodes, Chills Narrative:   Other Relevant History:
Presented to ED on 9/18/23 with SOB and cough that started 3 days prior. Patient discharged on 9/21/23 to a swingbed facility.
Smallpox (L arm)Hep B #1 ( R arm)Anthrax #6 (R arm) 09 Sept 03 Service member received anthrax and smallpox briefings and brochures prior to vaccinations.  No contraindications to vaccination.  Reports no complaints on this date.  14 Sept 03 Service member had a tattoo placed on his upper back-R scapular region.  No complaints on this date.   23 Sept 03 Noted a few lesions on his left upper arm.  Described them as red and slightly itchy.  Service member thought they were just ingrown hairs and attempted to pluck the hairs.  24 Sept 03 Reported to the Chemical Simulation (CS) Gas Chamber for training.  Upon exiting, his friend noted that he had lesions covering both arms and on his neck.  In the training exercise, he reports that he wore a mask but no other special protective equipment needed.  He did not experience any problems during the training and did not become "overly warm."  Reports that he was only in the gas chamber for a few seconds.  Has done this training numerous times in the past without any problems.Presented to the TMC and was referred. Service member is without complaints except for the numerous erythematous lesions on his extremities, neck, and R ankle.   No oral lesions or lesions on soles of feet or palms of hands. He describes them as non-tender and slightly pruritic.  Denies chest pain or shortness of breath.  No fever, headache, neck pain, abdominal pain, or fatigue.  Diagnosis: Non-viral Pustulosis Tx:  Zyrtec 10 mg po qhs
Severe, full body eczema. Began 1 day after injection of second shot. Persisted for more than 2 weeks. Severe, extreme eczema on torso, legs, face, neck, chest, arms and feet. Even with a history of eczema, the most severe eczema I have experienced in almost 5 years. The rash began at the injection site and spread across my entire body.
weak, sweaty, pale (? vasovagal) immediately after Flu vaccine. Itching at injection site L arm began within 5 minutes and spread to chest. Throat felt tight and lips tingled within 30 minutes.
received the 1st Moderna vaccine and is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 23-Oct-2020 and the estimated date of delivery was 30-Jul-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (received the 1st Moderna vaccine and is pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2020, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
could not walk,; nausea; weakness, over weakness; muscle pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk,), NAUSEA (nausea), ASTHENIA (weakness, over weakness), MYALGIA (muscle pain) and PYREXIA (fever) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OMEPRAZOLE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced GAIT DISTURBANCE (could not walk,), NAUSEA (nausea), ASTHENIA (weakness, over weakness), MYALGIA (muscle pain) and PYREXIA (fever). At the time of the report, GAIT DISTURBANCE (could not walk,), NAUSEA (nausea), ASTHENIA (weakness, over weakness), MYALGIA (muscle pain) and PYREXIA (fever) outcome was unknown.            Concomitant product use was provided by the reporter as High blood pressure medications, Heart medication. Treatment information was provided as paracetamol.   This case was linked to INC.-MOD-2021-076479, MOD21-075779, INC.-MOD-2021-076575, INC.-MOD-2021-076603 (E2B Linked Report).; Sender's Comments:   INC.-MOD-2021-076479:1st dose vaccine MOD21-075779:Crosslink, INC.-MOD-2021-076603:2nd dose vaccine - husband  INC.-MOD-2021-076575:2nd dose vaccine - husband
bilateral ovarian vein thrombus, thrombocytopenia - Fever, sepsis, altered mental status, nausea, vomiting
Sever swelling and pain in shoulder. Unable to lifft arm above head. Improved slightly but still having pain after 2 weeks from vaccination.
Pt c/o soreness in right arm pit area the following day post immunization. No redness at site or under arm pit, no "lumps felt in arm pit. The pain seems to be increasing, had HA yesterday but was controlled with Aspirin. No fever." Mother stated pt c/o stomachache post the immunization also.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 13-AUG-2013 the patient was vaccinated with a dose of GARDASIL, intramuscular injection, 0.5 ml (lot # H017698; exp.date 15-JUL-2015), that was improperly stored and exposed to 31F for 2 hours. No adverse effect was reported. Additional information has been requested.
zoster related vision loss; Shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) as prescribed and/or administered by a pharmacist for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation), the patient was treated by a physician for shingles (herpes zoster) and zoster related vision loss (blindness). On an unknown date, the patient was admitted to the hospital due to the events. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. At the time of this report, the outcome of herpes zoster and blindness was unknown. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, blindness was determined to be a medically significant event.
Red flushing of the face with cold chills and nausea Started around 2:30 pm the day after vaccine and lasted around 16 hours.
mom states sx began the day p/pt recv vax;sx included painful, swollen lymph glands, testicle & neck;was seen x 2 in ER was prescribed dicyclomine, Ibuprofen, Darvocet & APAP;mom reports sx still present 22AUG97 but some relief;
Initial unsolicited report received from a nurse (nurse manager) on 27-Sep-2016. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number: UI643AE, expiry date: 30 Jun 2017, dose, dose in series, and site of administration were not reported) intramuscularly on 22-Sep-2016. Illness at the time of vaccination was reported as was no and pre-existing physician diagnosed allergies, birth defects, medical conditions was none. Concomitant medications were not reported. On 22-Sep-2016, same day (overnight) following the vaccination, the patient had developed chills, muscle aches, and he felt warm but did not check his temperature. The patient was hospitalized on an unknown date (days of hospitalized reported as 1). On 23-Sep-2016, the symptoms were improved. The patient required ER/doctor visit. The patient's laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the events. List of documents held by sender: none. Sender's Comments: Patient felt warm, chills and muscle ache following FLUZONE QIV vaccine. Time to onset is compatible, but additional history regarding patient medical history, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be ruled out.
Coughing and nasal symptoms are listed as possible signs of Covid19 infection; reporting body aches; fever; watery eyes; sneezing; dry cough; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE), via an unspecified route of administration on 08Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history included Exposure to SARS-CoV-2 (around an elderly co-worker that tested positive for Covid19 infection). Concomitant medications were not reported.  The patient experienced body aches (not 'itch' as reported), fever, watery eyes, sneezing, and a dry cough. Caller wanted to know if these symptoms are normal? Coughing and nasal symptoms were listed as possible signs of covid19 infection. The patient had been around an elderly co-worker that tested positive for Covid19 infection, caller did not find out until after receiving his first dose. He spent 4 - 5 hours with him, before getting his shot. If he tests positive for Covid19 infection, how does that affect his next dose which was scheduled for 01Mar2021? The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 30-MAY-2017, the patient was vaccinated with and expire dose of GARDASIL (route, dose, dose number, frequency and anatomical location were unknown) with Lot # M014929 and expiration date 27-MAY-2017 for prophylaxis. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Fever and cold-like symptoms on Saturday afternoon;  woke to red itchy hives all over my neck, both arms, face, forehead, scalp, fingers, and ankle.
At 3:30pm, pt not feeling good, ached all over, throat sore, weak and pale. At 2:30am, 102.7 fever. At 3:30am, 102.7 fever. At 3:30am, felt better, dizzy and weak, arm very sore 100.7.
I had a couple of hive outbreaks during the week after the third shot, three hives were all over the body; Dose received 3; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 30Oct2021 at 12:00 (Lot number: FF2593)at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP7534, Anatomical site: Left arm, Administration time: 12:45), administration date: 23Mar2021, when the patient was 28 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EW151, Anatomical site: Left arm, Administration time: 11:45), administration date: 13Apr2021, when the patient was 28 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 30Oct2021 at 12:00, outcome "unknown", described as "Dose received 3"; URTICARIA (non-serious) with onset 03Nov2021, outcome "recovered" (an unknown date in 2021), described as "I had a couple of hive outbreaks during the week after the third shot, three hives were all over the body". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of urticaria.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Treatment included over the counter (OTC) antihistamine for urticaria. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19.
Description: Headache, Myalgias, UE/LE paresthesias worsening after each anthrax vaccine; SX beyond 30 days. Symptom: Headache, general start: 2/2/2003 End: 2/5/2003; Comment: pressure sensation ; Symptoms: Dizziness Start: 2/2/2003 End: 2/5/2003; Symptoms: Headache, general start: 3/1/2003; Symptoms Muscle Pain Start: 5/4/2003; Symptoms: Joint Pain, multiple joints start: 5/4/2003; Symptom: Weakness start: 5/4/2003; Symptom: Paresthesias start: 5/4/2003 Comment: R>L arm. Symptom: Hot Flashes Start: 5/4/2003; Symptoms: Paresthesias start: 10/5/2003 comment: left leg; Symptoms: Nodule, subcutaneous start: 10/05/2003 end: 10/20/2003 ; Comment unknown
Several weeks after second dose, experienced joint pain that kept increasing. Hip and back of left buttocks were center of joint pain, pain with left elbow. All on the left side of the body. Given melaxothan for inflammation, but did not help much. Did 2 months of PT, 11-12 sessions of PT, only experienced very short term relief. Saw an orthopedic surgeon, did a steroid shot to left hip. Icing and using heat, stretching, exercises from PT.  Pain is still lingering, nothing has seemed to make a difference. Was previously a very active person, exercised with pilates, aerobic walk, line dancing. (3 hours of exercise, 3 times a week). Now have trouble walking one half a mile.