chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles on right side of abdomen; This is a spontaneous report received from a contactable nurse, the patient. A 63-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 08Jan2021 at 08:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical condition. The patient did not have any allergies to medications, food, or other products. Concomitant medications included Vitamin D (MANUFACTURER UNKNOWN) within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration in the left arm on 18Dec2020 at 07:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Mar2021, the patient experienced shingles on right side of abdomen. The patient stated that she was diagnosed with shingles on her right side of abdomen. The rash appeared on 08Mar2021 but there was pain for one week prior to the rash appearing. Patient was healthy and have not had shingles before and she did not have the shingles vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received antiviral medication (unspecified) for the event shingles. The clinical outcome of the event shingles on right side of abdomen was resolving at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
2weeks after first shot, severe chest pain from base of esophagus to bottom of throat. Unable to lay on side or take deep breath without pain, jaw pain, shoulder pain. Eye  issue occurred same time, monitoring for retinal tear
DTaP placed right arm 05/12/2003. Presented 05/14/2003 with 7cm round, erythematous, tender area surrounding injection site.
**8 weeks pregnant, estimated due date 10/25/2021. 2nd pregnancy **  I had vaginal spotting. I went to see my Midwife, they had me do an ultrasound and drew some labs. I went back two weeks later and had blood drew again and everything came back normal. My Midwife told me she had a lot of people call and tell her they were spotting after there vaccine.
Pt creid continuously from time given to late evening very loudly; localized redness, & swelling; area of inject was feverish also; mom took pt to MD & was told not to recvd anymore DTP;
MUSCLE WASTING; NERVE PAIN; PAIN IN LEFT SHOULDER; STIFFNESS; PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced stiffness. On MAY-2021, the patient experienced pain. On an unspecified date, the patient experienced muscle wasting, nerve pain, and pain in left shoulder. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain in left shoulder, muscle wasting, and nerve pain, and the outcome of stiffness and pain was not reported. This report was non-serious.
Low grade fever 99.4; Swollen supraclavicular, humeral and pectoral lymph nodes of left arm; Dose Number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 12:00 (Lot number: FH8027) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "autoimmune urticaria" (unspecified if ongoing); "angioedema" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL / NORETHINDRONE ACETATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 21Apr2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 12:00, outcome "unknown", described as "Dose Number 3"; PYREXIA (non-serious) with onset 27Nov2021, outcome "recovering", described as "Low grade fever 99.4"; LYMPHADENOPATHY (non-serious) with onset 27Nov2021, outcome "recovering", described as "Swollen supraclavicular, humeral and pectoral lymph nodes of left arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, lymphadenopathy.  Additional Information: The patient did not have covid prior to vaccination. The patient did not have covid tested post vaccination. The patient did not have known allergy.   Follow-Up (02DEC2021): Follow-up attempts are completed. No further information is expected.
Swelling at the injections site; Swelling of the arm; Fever 103 °F; Dizziness; Vomiting; Generalized weakness, went to ER; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced nausea. On 17th February 2023, the patient experienced injection site swelling, swelling arm, fever, dizziness, vomiting and weakness generalized. The patient was treated with steroids nos (Steroids) and antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site swelling, swelling arm and weakness generalized were not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the dizziness, nausea and vomiting were unknown.   It was unknown if the reporter considered the injection site swelling, swelling arm, fever, dizziness, nausea, vomiting and weakness generalized to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The patient was self-reported this case. The reporter stated that after received Shingrix vaccine the patient experienced swelling at the injections site, swelling of the arm, fever of 103 degrees Fahrenheit, dizziness, nausea, vomiting, and generalized weakness. The patient stated that she was seen at the emergency department and received Steroids and Antibiotics as a treatment for this events. The reporter did consent to follow up.
The day after these 5 vaccines she developed a fever, urticaria and then a reactive arthritis in the left knee. Tender, swollen, red but abnormal cbc and sed rate (but elevated CRP). Over 3 days the knee swelling and pain and fever to belly totally resolved on ibuprofen above. No other symptoms. ? vaccine reaction.
pain is high up in arm. pain comes + goes. Iced area + put heat on area + took Advil
PATIENT COMPLAINED OF DIFFICULTY SWALLOWING AND LOWER LEGS FELT "ASLEEP AND TINGLING 15 MINUTES AFTER VACCINATION.   REGISTERED NURSE AT CLINIC ADMINISTERED DIPHENHYDRAMINE VIA IM RIGHT ARM. VITALS MONITORED AND 911 WAS CALLED.  PATIENT TAKEN AWAY BY EMT.
Started out itching at injection site. Itching for worse thru out the evening of 5/27. On 5/28 the area was warm to touch and a hematoma where the injection was and around that the area was very red feeling like sunburn about a 4 in radius around the injection site. It continued to get redder and itchy. Went to urgent care on 5/28. Diagnosed with having an allergic reaction to vaccine. Was given a topical steroid and allergy medicine.
Vax on Thursday. Friday morning fatigue, fever, severe headache, body aches and chills. Saturday: fatigue, fever, severe headache, worse body ache and chills, painful tongue ulcers. Monday: fatigue   body aches and chills, joint pain, painful tongue ulcers, full body itching, severe headache. Tuesday: sores on lower lip, fatigue, nauseas, dizzy, headache, full body itching. Wednesday: sores on lower lip, full body itchinh, nauseas, dizzy, fatigue
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. Since 26-JAN-2015, doses of RECOMBIVAX HB (lot#, expiry date, dose, route and dose number were not provided), which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients (dates unspecified). No adverse effect had been observed or reported. This is one of several reports received from the same source. Additional information has been requested.
Breakthrough COVID infection. Positive test 5/16/2022. Symptoms including shortness of breath and cough. Also has pneumonia.
Pt's right deltoid area red, swollen, warm to touch, tingling up and down arm.
Face blotchy eyes & nose swelling w/in 15 min ears swollen & red back of neck & head & back & chest; DPH given; 11DEC91 runny nose; no swelling of lips, tongue or throat;
I received the 1st vaccine at 0915; around 1800, I noticed I had a rash on my face, chest, abdomen, and back- I took Benedryl.  The 2nd vaccine, I did the same thing, only this time it was all over my body
4/14/2021 at ~8am, Patient was out of bed and in his wheelchair and consumed 100% of his breakfast. During lunch time, he only consumed 25% of his meal. At ~2pm, patient was noted to be unresponsive. Oxygen saturation was 88% and B/P was low and oxygen was administered and Oxygen Saturation increased to 92%. The patient was placed in bed and Dr and the family were notified. The resident was continuously monitored by the Hospice nurse, who happened to be on-site and the primary nurse. At ~6:30pm it was noted that patient was having labored breathing so 0.25 ml of Morphine Sulfate Solution 20mg/ml was administered with releif. At 8:30pm, patient expired.
developed a rash on my chest and one arm; headache; chills; Second dose administered on 11May2021 (First dose on 30Apr2021); This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 56-years-old via an unspecified route of administration, administered in arm left on 11May2021 (Batch/Lot Number: 0167) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient did not have covid prior to vaccination. Concomitant medications included levothyroxine sodium; simvastatin (SIMVASTIN); biotin and ubidecarenone (COQ10), all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 56-years-old on 30Apr2021 10:00 (batch/lot number: 8735) administered in left arm for covid-19 immunisation. The patient reported that the day after her second shot on 11May2021, she had a headache and chills on 12May2021 which went away after 12 hours after taking Aleve. Then on 19May2021, she developed a rash on her chest and one arm. Pharmacist has recommended Benadryl to resolve situation. Therapeutic measures were taken as a result of the events which included Aleve and Benadryl. The patient recovered from headache and chills on an unspecified date (reported as 12 hours after taking Aleve) while the patient was recovering from rash on her chest and one arm. The patient was not tested post vaccination.
On 2/16/2021, one week after receiving dose 1, patient was felt weak and was unable to get out of bed.  She was evaluated in the ER and hospitalized for pneumonia.  She received her second dose of vaccine on 3/9/2021.  On 3/30/2021, she felt the same way she had on 2/16/2021.  She went to the ER and was again hospitalized with pneumonia.  She also had severe gout flare up at the same time.  She continued to have respiratory problems, and in June of 2021 she developed the need for continuous supplemental oxygen.  Eventually, work-up for her shortness of breath and hypoxemia led to an echocardiogram which showed an EF of 29% which was a reduction from 50% in May 2019.  She was started on new heart failure medications at that time.  She was prescribed a Life Vest due to risk of arrhythmia due to markedly low EF.  She had a repeat echo after therapy for heart failure was initiated, and her EF had dropped to 23%.  She is now requiring BiPAP therapy due to new sleep apnea.
This spontaneous report was received from a physician refers to an unspecified number of patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose (at a temperature of 56 F for 1 hour) of ROTATEQ lot # M025568 (expiry date: 07-NOV-2017) (dosage not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
The evening of the third vaccination shot (booster,) I fell ill for two days. At the time of illness my pre-existing tinnitus was amplified to an extremely loud level and receded only a small amount after the illness caused by the booster. I have been struggling to deal with it ever since this incident.
Cluster migraines; Sore muscles; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Cluster migraines) and MYALGIA (Sore muscles) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Migraine (Cluster migraines).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced MIGRAINE (Cluster migraines) and MYALGIA (Sore muscles). At the time of the report, MIGRAINE (Cluster migraines) and MYALGIA (Sore muscles) outcome was unknown.            Concomitant medication not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Pt recv vax on 2/22/99; on 2/23/99 pt exp sternal chest pain radiating to back, chills, sweating x 6 hr, sore arm x1 day
MOM NOTICED THAT EVENING CHILDS ARM WAS SWOLLEN AND HARD. MOM DID NOT CHECK ARM THE NEXT MORNING, HOWEVER THURSDAY PM ARM WAS STILL SWOLLEN AND HARD, BUT NOW RED AND WARM TO TOUCH. MOM TOOK CHILD TO THE ER WERE THEY TREATED HER WITH ANTIBIOTICS, STEROIDS AND BENADRYL PER MOM. DOCTOR WAS COVERING PATIENT FOR ALLERGIC REACTION AS WELL AS A INFECTION PER MOM. INFORMED MOM WATCH FOR FURTHER SIGNS OF REDNESS IF INCREASED SYMTOMS TO THE EMERGENCY ROOM, DID NOT NEED A REVISIT HERE PER NURSE PRACTITIONER.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 01-JUL-2012, the patient was vaccinated with GARDASIL dose 1 0.5 ml, intramuscular. On 04-DEC-2013 the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular. No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a health care student refers to an unspecified patient of unknown age and gender. On 06-JUN-2014 the patient was vaccinated with expired dose of MMR II (subcutaneous, lot # 0683AE, Expiry date: 02-APR-2014). Pertinent medical history and concomitant medications were not reported. No adverse effect reported by the reporter. The outcome of the events was unknown. No further information was provided. Additional information has been requested.
Administration date 03Oct2021, dose number=3; Developed an itchy, red rash with open pustules and hard bumpy skin on the underside of my forearm; Developed an itchy, red rash with open pustules and hard bumpy skin on the underside of my forearm; Developed an itchy, red rash with open pustules and hard bumpy skin on the underside of my forearm; Developed an itchy, red rash with open pustules and hard bumpy skin on the underside of my forearm; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8730) in the left arm on 27Mar2021 (at the age of 59-years-old) and also received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) in the left arm on 03Oct2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension on an unknown date, renal cell carcinoma since on an unknown date in 2019 and radical nephrectomy on an unknown date in 2019. The patient had no known allergies. 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 medication included amlodipine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) in the left arm on 06Mar2021 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021, approximately 10 days after second vaccine and on 15Oct2021, at 07:00, approximately 10 days after the third vaccine (booster), the patient developed an itchy, red rash with open pustules and hard bumpy skin on the underside of her forearm. The patient was currently still experiencing this rash and she had 2 new pustules on her left calf now (at the time of this report). The reaction, after vaccine number 2 lasted about 3-4 weeks. On 03Oct2021, the patient had "administration date 03Oct2021, dose number=3". The events developed an itchy, red rash with open pustules and hard bumpy skin on the underside of her forearm resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events developed itchy, red rash with open pustules and hard bumpy skin on the underside of her forearm and included treatment with cortisone (MANUFACTURER UNKNOWN) cream. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events developed itchy, red rash with open pustules and hard bumpy skin on the underside of her forearm (onset date: 06Apr2021) was resolved on an unknown date in 2021. The clinical outcome of the events developed itchy, red rash with open pustules and hard bumpy skin on the underside of her forearm (onset date: 15Oct2021 at 07:00) was not resolved at the time of this report. The clinical outcome of the event "administration date 03Oct2021, dose number=3" was unknown at the time of this report.
Soreness in injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (arm left) on 31Dec2020 (10:00) to 31Dec2020 10:00 at single dose for Covid-19 immunization. The patient's medical history included GERD (gastroesophageal reflux disease). Concomitant medications were not reported. The patient has no allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced soreness in injection site on 31Dec2020 17:00 with outcome of recovering. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.
Pt received vaccines at her regularly scheduled 2mo PCP apt in the AM.  Much later in the day, about 15 minutes after a feed, She had a brief resolved unexplained episode of noted cyanosis lasting 5 seconds that resolved after her father picked her up.  She then presented to our hospital for evaluation and workup was unrevealing.  She had never had any prior episodes of cyanosis.  She has a history of coughing during feeds and "a few times a month" vomits forcefully after feeds.  Her parents do not reliably hold her vertically after feeds.
patient received multiple flu vaccines this season, no AE; Initial information received on 21-Jan-2020 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 41 years old male patient who received an extra dose of the vaccine INFLUENZA VACCINE [Flu vaccine] in a season.  Medical history included respiratory symptoms and loose stools.   Medical treatment(s), vaccination(s) and family history were not provided.  On 05-Nov-2019, the patient received a first dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On 20-Jan-2020 he also received a 0.5 ml second dose of the FLUENZA VACCINE produced by unknown manufacturer with an unknown batch number via intramuscular route in the left deltoid.  It was a case of actual medication error due to extra dose administered.  At the time of the report, no adverse events were reported.  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 Directive and Module VI of the 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.
Information has been received from a registered nurse concerning an 8 year old white female with no allergies or medical history who on 07AUG1998 was vaccinated with a first dose varicella virus vaccine live. There was no concomitant medication. It was noted that the pt had diarrhea at the time of vaccination. On 13NOV2003 the pt developed 10 to 20 papules on the back, legs and arm. There were also several small "welts." Atypical varicella was noted. A doctor visit was required and symptomatic treatment was provided. No diagnosticc laboratory tests were performed. The pt subsequently recovered. The reporter also indicated that neither the pt or her sibling had any adverse events following prior vaccination. No further info is expected.
Patient experienced tingling in both arms and began what appeared to be a panic attack.  EMT's were called and took the patient to the hospital where she received IV fluids and was discharged.
Subsequent to receiving vax, the pt developed a cough with a fever of 100 degrees. One day post vax the pts fever was up to 103.8. Two days post vax the pts fever rose to 105.4 and was accompanied by a stuffy nose. Pt had a normal exam and normal urine sample.