chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient requested a booster. Patient inadvertently given Pfizer when patient has already had a two dose Moderna series.
Whole body muscle ache. Fever 101.0 F   Sore injection site.  Headache.
Irritated tongue; Irritated tongue, Feels like it has been scalded.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 21May2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the right arm on 30Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 03Jun2021, the patient experienced irritated tongue that felt like it had been scalded. 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 not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events irritated tongue, feels like it has been scalded was not resolved at the time of this report.
This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a 18-month-old male patient who received BEXSERO. In October 2017, the patient received the 2nd dose of BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patient experienced shoulder pain (serious criteria disability). On an unknown date, the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the shoulder pain to be related to BEXSERO. Additional details were provided as follows: The patient had severe shoulder pain. The patient was still complaining of this pain. The patient underwent an ultrasound, but result was not reported.
Information has been received from a pharmacist concerning a 14 year old female who was vaccinated with a second dose of Gardasil. Subsequently the patient was diagnosed with Hodgkin's disease during Gardasil series. It was unclear if the diagnosis was before or "around the time of" the 2nd dose. The patient will be undergoing unspecified chemotherapy. Unspecified medical attention was sought. At the time of the report the patient had not recovered. The pharmacist was not linking the Hodgkin's to therapy with Gardasil. The pharmacist considered the Hodgkin's disease was an other important medical event as the patient will require chemotherapy. No further information is available. 7/21/08-records received for DOS 12/10-12/13/07- DC DX:Hodgkins lymphoma. Presented to begin therapy for Hodgkin lymphoma. Orignally presented on 11/28/07 for evaluation of left lower cervical lymphadenopathy and chest pain and diagnosis of Hodgkin lymphoma made. In late October 2007 noted large swelling and painful lymph node in left supraclavicular region. Left arm became numb and treated for lymphadenitis with parital resolution. Developed tight pressure in midsternal region.
Almost completely over stroke /Affecting left side; Blood clot in lower left leg; After shots balance worsened; Pressure on left side of face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "After shots balance worsened", "Almost completely over stroke", "Pressure on left side of face", "Affecting left side", "Blood clot in lower left leg". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Almost completely over stroke /Affecting left side"; THROMBOSIS (medically significant), outcome "unknown", described as "Blood clot in lower left leg"; BALANCE DISORDER (non-serious), outcome "unknown", described as "After shots balance worsened"; FACIAL PAIN (non-serious), outcome "unknown", described as "Pressure on left side of face".  Clinical course: Having reaction to shots (2 + 1 booster). Almost completely over stroke 10Dec2, affecting left side, & after shots balance worsened (98% now 80%) & now need a cane, blood clot in lower left leg & pressure on left side of face. All of these things occurring after shots. ER many times from COVID shots.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300049896 Same patient/event, same drug in different dose;US-PFIZER INC-PV202300018058 Same patient/event, same drug in different dose;
slight allergic reaction; This spontaneous report has been received from an anonymized provider referring to a male patient of unknown age. The patient's medical history, concurrent condition, and concomitant therapy were not provided.  On an unknown date, the patient received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, unit, lot #, expiry date, and route of administration were not provided). On an unknown date, the patient had a slight allergic reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and want to be given pneumococcal vaccine conj 7v (crm197) (PREVNAR) 20. At the time of reporting, the outcome of slight allergic reaction was unknown.   It was considered the slight allergic reaction to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
This case was reported by a physician via call center representative and described the occurrence of macrophagic myofasciitis in a patient who received HAVRIX. Co-suspect products included INFANRIX and PEDIARIX. On an unknown date, the patient received HAVRIX at an unknown dose, INFANRIX at an unknown doses and PEDIARIX at an unknown dose. On an unknown date, several years after receiving HAVRIX, INFANRIX and PEDIARIX, the patient experienced macrophagic myofasciitis. On an unknown date, the outcome of the macrophagic myofasciitis was unknown. It was unknown if the reporter considered the macrophagic myofasciitis to be related to HAVRIX, INFANRIX and PEDIARIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received about 15 vaccines in the year 2012 to 2014, three of them were GlaxoSmithKline vaccines (HAVRIX, INFANRIX and PEDIARIX). Currently in 2016, this patient got a biopsy done and the patient had macrophagic myofasciitis. The physician (neurologist) refused to provide further details as they were still gathering more information.
Patient died with an unknown cause. He was found on the kitchen floor with no blood present. We requested an autopsy but because the County Coroner said there was no foul play suspected, that they would not perform an autopsy on the body to determine the cause of death even though the family had requested an autopsy. The Funeral Home stated to us that it had the looks of a heart attack, but he was not qualified to make that determination. He stated that the way the blood had stopped and purpled in his neck, gave him the indication that the heart was unable to pump all the way.
Chills; arm a little sore; weak and tired; weak and tired; sore muscles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN6200) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "positive for Covid virus", start date: Nov2020 (unspecified if ongoing), notes: she tested positive for Covid virus last November. The patient's concomitant medications were not reported. Past drug history included: Nickel, reaction(s): "she is also allergic to nickel and cobalt which is in food and vitamin B12", notes: Verbatim: allergies; Formaldehyde, reaction(s): "allergic to formaldehyde bu that never consumed that as far as she knows"; Cobalt, reaction(s): "she is also allergic to nickel and cobalt which is in food and vitamin B12"; Vitamin b12, reaction(s): "Allergic to Vitamin B12". The following information was reported: CHILLS (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "arm a little sore"; ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 25Feb2021, outcome "recovered" (26Feb2021) and all described as "weak and tired"; MYALGIA (non-serious) with onset 25Feb2021, outcome "recovered" (26Feb2021), described as "sore muscles".  Additional information: Caller clarified that within 12 hours after getting the first dose of the Pfizer Covid vaccine on 25Feb2021, the patient experienced all the events. The patient was also allergic to nickel and cobalt which is in food and vitamin B12, allergic to formaldehyde but that never consumed that as far as she knows. Due for second dose on Wednesday this week.   No follow-up attempts are possible. No further information is expected.
PATIENT EXPERIENCED SYNCOPE ABOUT 5 MINUTES FOLLOWING ADMINISTRATION OF THE J&J VACCINE ON 9/10/21. HE FELL FACE FORWARD ON THE FLOOR RESULTING  IN A CONTUSION ABOVE HIS RIGHT EYEBROW, RIGHT CHEEK BONE AND RIGHT KNEE. PATIENT WAS PLACED IN A PRONE POSITION ON HIS BACK WITH HIS FEET LEVATED.   BP WAS 117/81 PULSE 84. WOUNDS WERE BANDAGED. PATIENT WAS RESPONSIVE TO QUESTIONS AND DID NOT APPEAR TO HAVE ANY DISORIENTATION DURING CARE OF  INJURIES. PATIENT WAS ABLE TO MOVE TO A SITTING POSITION AFTER 15 MINUTES AND ABLE TO STAND AND WALK AFTER 20 MINUTES
Soreness of right arm after each injection 1-4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 06Mar2021 at 11:00 as dose 1, single (Lot number: EN6199) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: HUMIRA taken for colitis, start date: Nov2020 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Soreness of right arm after each injection 1-4".  Additional information: Humira was Started about 2 years ago this last November. Dosage text: 40mg/0.4ml Injection twice monthly, every 2 weeks given in leg. Other Conditions were reported as no. They did not want Moderna, so all of them were Pfizer. Vaccination Facility Type was 1st two were at a site that the (facility withheld) set up. Prior Vaccinations (within 4 weeks) was none. Family Medical History Relevant to Adverse Events (AEs) were none.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201369165 similar report from same reporter;
Redness that is spreading out from the injection site. Feels hot to the touch, patient says can't have any clothing touching it or it is painful. Slightly swollen. Patient already contacted doctors office, informed patient to take some Benadryl and see if that helps.
Areas of induration and cellulitis at both injection sites. Worse on (R) arm. Temp of 99. Sx began 2 days after injection. No issues in past w/imms. Tx with Keflex 500 mg 3x7days. RTC for reevaluation.
Four hours after getting both a COVID booster and the flu shot, both in my left arm, my left ring finger became numb. This lasted for several weeks. It gradually started getting better. I eventually contacted my doctor who said that since it was getting better not to be concerned but to come back if it started to get worse. I do not wear a ring on that (or any) finger, nor do I wear a watch or any bracelets. As of today I would say the feeling is 99% back. There is just maybe a little bit of numbness left.
PATIENT EXPERIENCED WELTS UNDER LEFT EYE (NEAR SINUSES) FRIDAY MORNING, AND BY EVENING WELTS APPEARED UNDER RIGHT EYE. THE WELTS WERE TENDER BUT NOT ITCHY. OVER THE WEEKEND, SHE HAD A HEADACHE WHICH SHE TREATED WITH EITHER MOTRIN OR TYLENOL.  MONDAY MORNING SHE HAD A LOW GRADE FEVER (99 DEGREE) AND THE WELTS HAD IMPROVED SIGNIFICANTLY.  SHE SAYS SHE FEELS FINE AND SHE IS OK.
Initial report was received from a healthcare professional on 01 July 2013. A 17-year-old female patient had received an intramuscular injection in the right deltoid of MENACTRA, lot number U4594AB on 24 June 2013. Five days post-vaccination on 29 June 2013, the patient broke out in generalized hives. She was evaluated and treated with epinephrine and MEDROL pack at the emergency department. On 01 July 2013, the patient was seen by a physician and was prescribed TAGAMET, ATARAX and VALTREX for cold sores and diarrhea. The patient denied any illness at the time of vaccination and had a history of scoliosis and no known allergies. Outcome was unknown. Documents held by sender: None.
Reported and experienced common side effects:  fever, body aches, soreness, and headache appeared within 24 hours of second dose. However, my menstrual cycle also occurred 1 week late.  Also for the past 3 months since then, I have experienced spotting shortly before the onset of my cycle.  I have been trying to conceive, and I am wondering if the vaccine has had an impact on my fertility.  My menstrual cycle had always been regular prior to the second dose.
Information has been received from a Registered Nurse concerning a 20 week old patient who on 15-OCT-2010, was vaccinated with the first dose of ROTATEQ (route, dose and lot# not provided). The patient sought unspecified medical attention. Additional information has been requested.
3/10/10 - Received phone call from patient, relating that she received "shingle shot" earlier (on 3/30/09) and now has severe right side back pain that radiates to the front. Pain began 3 days ago. Today she noticed a "spot" on her back. Went to ED on 3/8 and saw family Dr 3/10. On 3/10 - Back to ER - diagnosed with shingles - given script for acyclovir.0
Large rash on arm at the injection site. Rash was approximately 6 in. long, 3 in. wide. Raised, Red bumps, sore, pain, and itchy.
2nd dose has not been administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received several years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose has not been administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter reported that several years ago the patient received first dose of Shingrix vaccine and did not received second dose. The reporter wanted to know if need to restart the series. The reporter did consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
nausea; Body aches; headache; chills; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) 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: NAUSEA (non-serious), outcome "unknown", described as "nausea"; PAIN (non-serious), outcome "unknown", described as "Body aches"; HEADACHE (non-serious), outcome "unknown", described as "headache"; CHILLS (non-serious), outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUSITIS (non-serious) with onset 28Mar2021, outcome "unknown", described as "Sinus infection". Additional information: She received her 1st dose last 09Mar2021, but then got sinus infection on 28Mar2021 (last Monday). She experienced headache above the eye particularly above the eye, had some yellow discharge as well, and her doctor prescribed her antibiotics (treatment). She had not yet taken them because she is not sure whether this will affect the 2nd vaccine (Unspecified Vaccine) that she is going to have. The 2nd is scheduled on 02Apr2021 by the facility; however, that would be more than 21 days already. So from 09Mar2021, 28 days is 30Mar2021, but then she was scheduled 02Apr2021. She just wanted to know if she should take the antibiotics or if she should wait until after she had 2nd dose. Furthermore, she is asking for how long after she can then start taking it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe arm swelling, redness, fever,cough arm pain, cough, felt weak 3/21/2020 until 3/25/2020
Patient did not receive the second vaccine dose with in the dosing window; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second vaccine dose with in the dosing window) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second vaccine dose with in the dosing window). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second vaccine dose with in the dosing window) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has a history of Cancer, and recently her cancer came back and currently she is under chemotherapy treatment.  Concomitant product includes antibiotics medication, steroid medication.  . No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up received on 02-JUN-2021 contains patient's demographics and vaccine facility information.
Received vaccine on a Friday. Ultrasound the following Wednesday showed fetal pole with no heartbeat measuring 5 weeks and 6 days. Had follow up ultrasounds on 10/6 and 10/11 showing no growth.
Bruises on both legs; Extremely tired; Achy all over; This spontaneous case was reported by a pharmacist and describes the occurrence of CONTUSION (Bruises on both legs), FATIGUE (Extremely tired) and MYALGIA (Achy all over) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced CONTUSION (Bruises on both legs), FATIGUE (Extremely tired) and MYALGIA (Achy all over). At the time of the report, CONTUSION (Bruises on both legs), FATIGUE (Extremely tired) and MYALGIA (Achy all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medication were not provided.
Patient received the SHINGRIX shot on 02/04/2021 and called me on 03/01/2021 to tell me that her arm was still sore where I gave her the shot. Not redness or hardness to the are just sore.
Dose 1 (8/6/21):  Headaches for 1 week following shot  ; Dose 2 (8/27/21):  Daily Persistent Headaches ongoing since shot as of today, Shingles ongoing from 10/3/21 --continued rash/pain as of today
Noted onset of redness on (L) forearm approximately 10 cm diameter. Given cephalexin on 5/13 by another physician. Today 5/15 site normal.
Severe, pounding headache that started while driving. Accompanied by severe photophobia and nausea. Vertigo started one day later, along with the headache. Headache increased in intensity over 5 days, unrelenting. Headache resolved 7 days after it started.
ACHING PAIN AT THE SITE OF THE INJECTION.  ACHING PAIN IN MY LEFT SHOULDER, LEFT UPPER ARM, LEFT SHOULDER BLADE AND LEFT SHOULDER.
headache, rapid heart rate for several hours (160s), nausea, joint aches, chills, dizziness, weakness. Worst part lasted 48 hours. The nearest ER is an hour away so just pushed thru it.
PCP examined Dx with Henoch-Schonlein purpura (pediatric endocrinologist).
Rash that extended from back of neck to back / Rash was itchy; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 21 days after receiving Shingrix, the patient experienced itchy rash. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient who is also a retired pharmacist. The patient started to have a rash that extended from back of his neck to his back and the rash was itchy. The patient consented to follow up. This case has been linked with case US2019AMR206374, reported by the same reporter.
60 y/o Hispanic female c/o dull left temporal area headache 7/10, sour taste in mouth and tingling in bilateral legs 15 mins after receiving 2nd dose of the vaccine. She reported that she had similar symptom with first dose of the vaccine, has Hx of migraine, takes no meds and she last ate at 9am (6 hrs ago). She was assessed and monitored by NP, EMT, and paramedic. BP - 129/86, HR - 65, resp - 14, O2 sat 98% on RA. Pupils size 4, PERRL, MAE. She was given snacks and H2O and kept at site until she reported that she felt better and had no complaints. She was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to call 911and go to the ED, see her PCP, register with V-safe. She verbalized understanding and willingness to comply. Also instructed to take Tylenol 650mg Q6h PRN headache. She left site in no acute distress, awake, alert, oriented to person, place, time and situation.