chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported he had tingling sensation in arm at the injection site and went down to his toes. Patient reported he has numbness in middle finger. Neurologist diagnosed him with neuropathy. He was prescribed medication to treat.
Had shots had shingles anyway suspected/Suspected vaccination failure; Mild case of shingles; Had three of the shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shots had shingles anyway suspected/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Mild case of shingles) and extra dose administered (Verbatim: Had three of the shots). The outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 09-MAR-2023 The case  was received from the patient via interactive digital media. The patient had three of the Shingles shots and had a small case of shingles anyway. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received 3rd dose of Shingles vaccine, which led to extra dose administered. The follow-up could not be possible as no contact details were available.
Sluggishness, tired, slight fever and chills.  Sore arm at injection site.
The patient was monitored for 15 minutes post vaccination with no issues. However on the drive home, she noticed some numbness of her right face as well as drooping on her eyelids. The patient came back to the hospital where she received her vaccine and checked into the ED. Physician's differential included Bell's Palsy vs CVA/TIA. The patient was discharged with prednisone 20mg daily for 7 days.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: Patient complained of slurred speech after vaccine administration, upon checking vitals an increase in blood pressure was noticed. EMS was called. Patient chose to go with EMS to Emergancy Room to be monitored. RPH followed up with patients sister and they confirmed that hospital staff is keeping her in the hospital overnight for observations.
about 8 hrs after shot stomach ache, unable to eat dinner.  a few hours later, mild chills. next day, fatigue, lots of napping, and repeat of evening stomach ache, more severe, and also ache at kidneys on back. later chills. third day still fatigue, another evening stomach ache, no dinner, bland snack, less severe. later chills. 4th day, less fatigue, stomach ache but milder, no chills. 5th day no symptoms, more energy, almost normal.
4/28 - fatigue, chills, sore arm 4/29 - lightheaded and dizzy 5/1 - exhaustion 5/3 - severe diarrhea, dizziness, shallow/rapid breathing, dehydration  ? went to emergency room
Moderna COVID-19 Vaccine EUA  Injection arm red, swallow, itchiness, may be considered as ?Moderna Arm?
This spontaneous report was received from a 55 year old female patient (who was also a lab technician) referring herself. The patient's pertinent medical history included leg cramps, bacterial meningitis in 2009, degenerative disease, arthritis, herniated disc, nerve damage in right leg, gastrooesophageal reflux disease, hyperlipidemia, hepatitis C and the patient was allergic to BIAXIN (had swelling of tongue and lips), COMPAZINE (had unspecified reaction) and also experienced hallucinations with unspecified narcotics. On 30-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were not reported). Concomitant therapies included PROAIR, KLONOPIN 9as needed), budesonide, SYMBICORT (reported as the patient had not used for approximately the past 7 days because she ran out of medicine), lorazepam 9as needed), DEXILANT and LINZESS. On 02-FEB-2015, patient noticed that the gland on the right side of her neck was swollen, her throat was also hurting when swallowing. The patient looked in to her throat using a mirror and saw that her tonsils were covered in white patches and had some bleeding. The patient did not sought medical attention. The patient was treated by gargling with peroxide and placing a heating pad on the neck. No lab tests were performed. On 03-FEB-2015 (reported ad this morning), the appearance of tonsils was improved. On 03-FEB-2015 (reported as starting today), the patient experienced headache and itching of her right ear. The outcome of gland on the right side of her neck was swollen, itching of her right ear, headache, tonsils were covered in white patches and had some bleeding and her throat was also hurting when swallowing was reported as not recovered/not resolved. The causality of the events was not reported. No product complaint was reported for ZOSTAVAX. The specimen was obtained on 03-FEB-2015 and the source of specimen was throat swab. The patient did not had any recent Varicella Zoster Virus (VZV) exposure to chicken pox or shingles. This case is linked to the case 1502USA009294 via same reporter link. Additional information has been requested.
an 81 y.o. female with Hx lymphoma, recurrent UTIs, who presents to the hospital for evaluation of right hip pain.  This morning she went into the garage to get something and her slipper came loose and she tripped and fell with immediate right hip pain.  Her pain was improved with IV morphine given in the ED but she feels it is starting to wear off. Of note approximately 10/22 she and her husband at bedside developed sore throat, sinus drainage, cough.  They took over-the-counter Robitussin and analgesics with improvement of symptoms, however her cough was at some point bad enough to cause sore ribs.  At this time she denies any acute respiratory symptoms, change in taste/smell.  They did stop at their nearby pharmacy for field testing on the way in because they were suspicious that had COVID-19.  COVID-19 infection ?Symptom onset reported 10/22 ?Requiring 2 L/min NC in the ED to maintain O2 sat at 90%, denies any history of tobacco use/pulmonary disease ?Obtain CTA of the chest, if evidence for Covid will initiate therapy due to hypoxia
Rash over entire body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over entire body) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced RASH (Rash over entire body). The patient was treated with LORATADINE at an unspecified dose and frequency. On 14-Mar-2021, RASH (Rash over entire body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided
Initial report received on 28-OCT-2005 from a healthcare professional in USA. A 4-year-old male child patient with no reported medical history received two doses of FLUZONE on 24-SEP-2005 and 25-OCT-2005, respectively. It was reported that, however, it was not the first time the patient received the vaccine. The patient did not experience any reaction following the first dose and complained of myalgia at an unspecified time. Physician stated that the patient had normal temperature upon examination. Patient also complained of nausea at an unspecified time and he was not recovered at the time of the report.
This spontaneous report was received from a physician regarding a 43 year old female patient. The patient's concurrent conditions was not reported. The patient did not have any drug reaction or allergies, her pertinent medical history was not reported. On 13-JUL-2015 the patient was vaccinated with PNEUMOVAX23 (lot # L003227/ expiry date: 12-OCT-2016), (Dose 0.5 ml, intramuscular). Concomitant medications were not reported. On 13-JUL-2015, within about 5-6 hours of administration of PNEUMOVAX23 the patient experienced severe swelling and redness around injection site, high fever, stiff neck and cellulitis. The patient sought medical attention and went to emergency room (ER) twice on unspecified dates for symptoms that she had been experiencing but patient was not admitted to hospital. On an unknown date the patient  was treated with unspecified intravenous and oral antibiotics. On an unspecified date the patient also had a follow-up checkup with the reporting physician. The reporter stated that the patient had missed 2 days of work due to adverse event symptoms. A product quality complaint was not filed. The physician reported that as of 21-JUL-2015 patient's symptoms have resolved. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Pt. developed baseball sized area of erythema 1 day after receiving vaccine, in (R) upper arm. Area of erythema was warm to touch and itchy, without pus or sign of infection.
30 min after vaccine administration pt returned to pharmacy counter and said her facial cheeks felt numb. no other side effects.
Tetanus (L) arm 6 d ago. Next AM noted disc (L) axillary this AM with discomfort about medical episode/ (L) elbow. No erythema - No fever - No systemic Sx - No neuro scan. Not taking any meds.
I was having a heart attack.; My heart rate was increased starting the night I got my second dose (my first dose as well).; I had trouble breathing; nausea; and struggled to sleep for days because it felt like my heart was beating out of my chest.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3184), via an unspecified route of administration, administered in arm right on 03Sep2021 at 14:00 (at the age of 31-years-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EW0167), administered in right arm on 04Aug2021 for COVID-19 immunisation and experienced 'My heart rate was increased starting the night I got my second dose (my first dose as well)'. The patient was hospitalized on an unspecified date, thinking he was having a heart attack on 03Sep2021 at 22:00. Also, on 03Sep2021 at 22:00, his heart rate was increased starting the night he got his second dose (his first dose as well). He had trouble breathing, nausea, and struggled to sleep for days because it felt like his heart was beating out of his chest. The patient was hospitalized all events on unspecified dates, for 1 day. The patient underwent lab tests and procedures which included echocardiogram and X-ray (What treatment received for the adverse event? heart ultrasounds, x-ray), both with an unknown result. Therapeutic measures were taken as a result of all events which included Saline solution, heart ultrasounds, X-ray. The adverse events resulted in emergency room/department or urgent care. The outcome of the events was recovered/resolved with sequel on Sep2021.  No follow-up attempts are needed. No further information is expected.
Fever, Chills, Fatigue, Headache, chest tightness, trouble breathing, cough, ears stopped up saw a dr on monday 10/4/2021 and had a chest xray and recvd steroids and inhaler there saw my asthma dr friday 10/8/2021 recvd antibiot and more inhaler  still sick with cough today 10/20/2021
PCP sent pt to ED with elevated creatinine; pt c/o nasal drainage and fevers x 2 wks; positive test for COVID; DNR; pt's condition worsened and family chose extubation; pt died in the hospital
Patient received FLUZONE HIGH DOSE (FOR age 65 and older) by accident instead of a different flu vaccine for under age 65
PATIENT STATES THAT HE WOKE UP ON THE MORNING OF FEB. WITH HIS EYE SWOLLEN SHUT.  HE WENT INTO SEE
pt recvd vax;mom called hlth dept 30nov94;started screaming, sl jerking of arms, legs since 5pm 29nov;apap given q 4 hrs;advised to see MD asap;fever 103 ax;mom able to get fever down to 100.5 ax;
SEVERE ABDOMINAL PAIN; DIARRHEA; PERSISTENT VOMITING WITH BLOOD COMING OUT; NON BLEEDING GASTRIC ULCER; NON BLEEDING HEMORRHOIDS; COLITIS; ESOPHAGITIS; ACHES; CONGESTED MUCOSA; RASH ON STOMACH; CHILLS; FEELING OF WEAKNESS; HEADACHE; NAUSEA; FEVER; FATIGUE; DIZZINESS; This spontaneous report received from a consumer concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 15029 Patient couldn't read lot, and expiry: unknown) dose was not reported, 1 total administered on 25-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021, the patient experienced dizziness right away after vaccination. Within couple of days she started to had the other symptoms. On 26-MAR-2021, the patient experienced diarrhea. On an unspecified date, the patient experienced severe abdominal pain (seems to be chronic), persistent vomiting with blood coming out, non bleeding gastric ulcer, non bleeding hemorrhoids, colitis, esophagitis, congested mucosa, rash on stomach, chills, headache, nausea and fever. Some symptoms were on and off but had persistent aches, feeling of weakness and fatigue. On 02-JUN-2021, the patient was hospitalized and discharged on 04-Jun-2021. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) congested mucosa, non bleeding internal hemorrhoids, Body temperature (NR: not provided) 101, and Colonoscopy (NR: not provided) congested mucosa, non bleeding internal hemorrhoids (was banded in the colonoscopy). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from colitis, rash on stomach, persistent vomiting with blood coming out, non bleeding gastric ulcer, non bleeding hemorrhoids, esophagitis, diarrhea, severe abdominal pain, aches, dizziness, congested mucosa, chills, feeling of weakness, headache, nausea, fever and fatigue. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210626711-covid-19 vaccine ad26.cov2.s-Diarrhea, Severe abdominal pain, Persistent vomiting with blood coming out, Non bleeding gastric ulcer, Non bleeding hemorrhoids . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Urticarial rash post vaccine, IM Solumedrol, benadryl.
Myalgia generalized muscle aches and chills Narrative:  Tylenol alternating with Motrin  Other Relevant History:
I started shaking uncontrollably approximately 9 hours after injection. My teeth were chattering so badly they hurt. This maintained for 20 mins. I then had severe flu like symptoms overnight, including chills, and feeling hot and cold at the same time.  I woke up with a headache. I had muscle pains through the entire ordeal.  At 7am the next day, I took 600mg of ibuprofen and took a walk. I then felt fine.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 5th September 2018, the patient received the 2nd dose of SHINGRIX. On 5th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In September 2018, the patient experienced headache and fatigue. On 6th September 2018, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the headache and fatigue were unknown. It was unknown if the reporter considered the injection site pain, headache and fatigue to be related to SHINGRIX. Additional details were provided as follows: On 5th September 2018 08:30, the patient received SHINGRIX on the left arm. The reporter received the SHINGRIX vaccine and was experienced soreness and pain at the injection site that lasted the whole day. On 6th September 2018 13:00, 1 day 4hr 30min after receiving SHINGRIX, the patient experienced headache and fatigue. On the day of reporting the patient's soreness and pain was almost fully resolved. The reporter gave permission for his physician to be contacted. Unable to obtain additional information.
Information regarding PREVENAR was received from a company representative regarding a male patient who experienced decrease in babbling. The patient received the second dose on an unspecified date. After receiving the second dose of PREVENAR therapy it was reported that the child "stopped babbling as much". It was noted that the physician decided not to give the next dose. The child is now eight years old. No further information was provided.
Developed progressive aching in shoulders, hands, hips & fingers four mos p/rec'd 2nd dose of vax; Initially, it was thought pt had experienced arthralgia but later, p/couple mos of therapy dx w/polyneuropathy or polymyositis;
COVID 19 Treatment; COVID 19 Treatment; Dose Number 3, Pfizer / BioNTech; Dose Number 4, Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 5 (booster), single (Lot number: Ofi6739) and on 01Aug2023 as dose 6 (booster), single (Lot number: As7642b) at the age of 68 years for covid-19 immunisation; bnt162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9261), on 22Feb2021 as dose 2, single (Lot number: En6201) and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 19Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Apr2022, outcome "unknown", described as "Dose Number 3, Pfizer / BioNTech; Dose Number 4, Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 09Sep2023 to 14Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Patient had itchy rash on back but very little around vac. site. Patient is going to see md abotu treatment.
4 hours after vaccine, patient experienced numbness and tingling in left arm which radiated to left side of face. Face felt heavy for 24 hours. No drooping noted. Did not seek medical attention, symptoms resolved after 24 hours.
Elevated heart rate after second dose. Will not go back to normal.; This is a spontaneous report from a contactable consumer or other non HCP (patient reported for self). An elderly male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EE9265, Expiry date: unknown), via an unspecified route of administration, administered in Left arm on 27Feb2021 as dose 2, single for COVID-19 immunization. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EE9265), via an unspecified route of administration, administered in Left arm on 05Feb2021 as dose 1, single for COVID-19 immunization. Medical history reported as none. Patient had no known allergies. The concomitant medications. was not reported. On 27Feb2021, the patient experienced elevated heart rate after second dose, will not go back to normal. The patient underwent lab tests and procedures which included heart rate was elevated on 27Feb2021. Patient was not tested for COVID post vaccination. Patient did not receive any treatment. The clinical outcome of event was reported as not recovered.   No follow-up attempts are possible. No further information is expected.
Severe Vomiting, fever, pale, chills, weak, rash at site of injection.
Severe muscle stiffness.  Inability to rotate neck, make a fist, stand for more than two minutes. Back spasms, pain with breathing.  Eeded assistance to rise from bed or sitting position.   Lowgrade temperature and headache,but this was expected. Symptoms lasted approximately 60 hours.
Approximately 8 hours after receiving the first dose, my torso, arms, neck, and face began to itch; My hands were swollen; This is a spontaneous report from a non-contactable consumer (patient). A 38-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number: Not reported), via an unspecified route of administration, administered in Arm Left on 20Mar2021 09:00 (at the age of 38 years-old) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Sulfur of all types in medications, foods, health and beauty products, etc, food allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included calcium, vitamin d, flonase, Zyrtec taken for an unspecified indication, start and stop date were not reported. On 20Mar2021, the patient experienced approximately 8 hours after receiving the first dose, my torso, arms, neck, and face began to itch, my hands were swollen. Therapeutic measures were taken as a result of approximately 8 hours after receiving the first dose, my torso, arms, neck, and face began to itch, my hands were swollen included treatment with benadryl. The clinical outcome of the events my torso, arms, neck, and face began to itch, My hands were swollen was recovered/resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.