chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in head/cannot brush or dye hair because of pain; shingles in her hair; Blister in her head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (pain in head/cannot brush or dye hair because of pain), HERPES ZOSTER (shingles in her hair) and BLISTER (Blister in her head) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (pain in head/cannot brush or dye hair because of pain), HERPES ZOSTER (shingles in her hair) and BLISTER (Blister in her head). At the time of the report, HEADACHE (pain in head/cannot brush or dye hair because of pain), HERPES ZOSTER (shingles in her hair) and BLISTER (Blister in her head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was unknown.
"Major" Dizziness, headache, weakness, vision impairment, vomiting.
4 yo male received PREVNAR 13 on 27 Jun 2011. On 29 Jun started having redness/swelling in (L) thigh (whole thigh) where received vaccine. Was swollen and hard. Was given MOTRIN and seen next day at doctor office. Swelling/redness has decreased. Getting better. Pt has h/o complete PCV-7 series with last dose in 10/2007.
Pt noted small papular lesions that had ? on his neck on 2/7-2/8/03. Went and was evaluated. Tx with topical hypocortisone additional ? Rash spread to hands/face involving ears/lips on 2/11-2/12. Was given Allegra cont. f/u (-) HLA no other consitutional sx. Sore to site. Was sent for eval. Tx otitis exterma.
Tinnitus after the Second vaccine; Dose administration date: 31Jul2021/dose number: 2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Jul2021 as dose 2, single (Lot number: Er8731) at the age of 57 years, in left arm for covid-19 immunisation. The patient relevant medical history included: "COPD" (unspecified if ongoing), "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR. The patient was not received other vaccine in four weeks. Vaccination history included: BNT162b2 (Dose 1, lot number: Er8730, vaccine location: Left arm), administration date: 23Mar2021, when the patient was 57-year-old, for COVID-19 Immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 31Jul2021, outcome "unknown", described as "Dose administration date: 31Jul2021/dose number: 2", TINNITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "Tinnitus after the Second vaccine". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Patient received vaccine Facility in Doctor's office/urgent care.
a patient got two Fluzone High Dose in a couple of days, no AE; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves a 69-years-old male patient who was vaccinated with 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, lot UJ501AB and expiration date was 30-Jun-2021) on 12-Oct-2020 via an unknown route at an unknown administration site and received another dose on 13-Oct-2020 via an intramuscular route in the right arm for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not reported.   This was an actual medication error case due to extra dose administered (latency was same day).  At the time of reporting, patient had no adverse event 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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain in my right knee not going away; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm  on 09Apr2021 at 09:30 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 19Mar2021 at 09:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 10Apr2021, the patient experienced pain in right knee which was not going away. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain in right knee not going away was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
8/2--presently admitted 52y.o. male with PMH including NICM EF 10%, HFrEF, hx DVT and PE, DM2, CKD, HTN, PAF on warfarin, lisinopril allergy who presented for SOB x 2-3 days a/w BL leg swelling. His daughter was recently diagnosed with COVID-19 and his test in the ER is positive. He was previously evaluated in the office for ICD and CRT-D was recommended. He was originally interested, but decided not to schedule it. He is now interested in getting an ICD. He has wide IVCD so plan for CRT-D with EP physician. Will have our office schedule this as an outpatient once he has recovered from COVID/is out of isolation.Continue GDMT with BB with Coreg 3.125mg BID, Valsartan 40mg daily and Aldactone 25mg daily
Pt recv vax on 10/26/98; post vax pt missed chair-fell & fx hip
Started 6/30/07, swelling under rt arm. no redness or swelling noted at injection site. States lump under arm painful to touch. 7/2 talked with Dr-did not seem to think it is vaccine related. Advised to go to primary physician
After receiving my second shot in April 2018, I began to experience increased sensitivity to noise, light, and smell. At the same time I also became fatigued and lightheaded easily and lowered my blood pressure. I received the third shot in October 2018 and the symptoms I had been experiencing became worse and they gave persisted until today.
The day after my 2nd shot I had chills all day. I remained bedridden and tried to keep warm.  I also had no appetite, so forced myself to eat 1/3 can of chicken soup. On the 4th day after my shot and taking a morning shower (within about 15 minutes), I had a sudden itchy, pink body rash with water blisters on my thighs. It was awful! I applied frozen food packages continually, back and forth, trying to alleviate the itchy rash. I must add that everyone I have talked to since, also have had an adverse reaction to the 2nd shot but they are not reporting it. I didn't go to the doctor because I have no insurance. I am ok now, aside from the small scars from my bloody scratches.
"Low" temperature - 97/96.4 day after 4 mo immun. +mild URI sx also at time. Pt went to ER - labs including CBC, U/A WNL. Admitted for obs. 9/26/07-records received from facility for DOS 12/18-12/21/05-Status post vaccinations 3 days prior to presentation to ER with fussiness, decreased oral intake and hypothermia. Temperature 96.7 (R). Child unable to maintain a temperature outside of a warmer and was admitted.
Information has been received from a physician concerning a 9 week old Caucasian female with no past medical history who on 12 JUL 1999 was vaccinated in the right thigh with the first dose of Haemophilus B conjugate vaccine (Lot #629513/1771H). Concomitant vaccinations on 12 JUL 1999 included a first dose of oral rotavirus vaccine (RotaShield)(Lot#4988043), a first dose in the left thigh of diphtheria toxoid + pertussis vaccine + tetanus toxoid (Acel-Imune)(Lot #903A2), the first dose in the left thigh of poliovirus vaccine (IPOL) (Lot#N0957), and the second dose in the right thigh of hepatitis b vaccine, recomb (Engerix-B) (Lot#ENG2934A2). There were no illnesses at the time of vaccination. On 19 JUL 1999, the patient developed "severe" colic and "uncontrollable screaming". It was reported that the patients mother changed the infant's formula. The physician noted that the symptoms lasted approximately two weeks. Subsequently, the patient recovered. No further information is available.
having a brief, weird sense of smell; she felt lightheaded; having an arm slightly sored; facial tension; anxiety; This is a spontaneous report from a contactable nurse (patient). This (age: 62; unit: unknown) female nurse reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm on 21Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Nurse stated receiving the COVID-19 vaccine last Monday (21Dec2020), after which she experienced immediate and random side effects. She explained having a brief, weird sense of smell, then within three minutes, she felt lightheaded which was strong for 15 minutes and went away within 30 minutes. She specified that the lightheadedness didn't feel like anxiety. She mentioned having an arm slightly sored and a facial tension which also occurred within that 30 minutes period. She added having an other symptom, but didn't specify it, saying that she wasn't certain if her symptoms were related to the vaccine or to anxiety. She expressed being reluctant to receiving the second dose of the vaccine. She then asked if her symptoms were commonly reported side effects of the COVID-19 vaccines. It was reported as non-serious. Outcome of events weird sense of smell and lightheaded was recovered, and the rest of events was unknown.   Information on lot/batch number has been requested.
shortness of breath; dizzy; felt very unwell; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in right arm on 22Apr2021 at 10:00 as a single dose for COVID-19 immunization. Medical history included Lupus and Hypothyroidism from an unknown date and unknown if ongoing. Patient had known allergies to Suprex and Septra. Concomitant medications included methylprednisolone acetate (MEDROL [METHYLPREDNISOLONE ACETATE]); naltrexone for lupus, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient had received a DePo medrol Steroid Shot and is on Low Does Naltrexone for lupus. On 22Apr2021, at 04:00, 5 hours after the shot she became very dizzy and shortness of breath. She also felt very unwell. Day two, she felt worse and could not breath alerting me to go to the ER to get checked out. The event resulted in: Emergency room/department or urgent care. The patient received treatment due to the events with ativan shot. The clinical outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recvd vax & the next day had fever (101.7), nausea, fatigue & myalgia; pt was seen by MD pt indicated that approximately 10 day p/inject was fully recovered;
This serious spontaneous case, initially received from other health professional on 12-Jan-2018, concerns a 27-year-old, adult, female patient. The patient's current conditions included seasonal allergy for which no treatment was taken and knee pain (since unspecified dates). The patient was not taking any concomitant medications. It was reported that patient did not receive any flu vaccine in past and had no flu symptoms prior to vaccination. On 09-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195249 and expiry date: 30-Jun-2018). On the same day (09-Jan-2018), after vaccination, the patient had no flu symptoms. On 10-Jan-2018, 2 days after vaccination, the patient had cough, felt itchy and aching throat. On 12-Jan-2018, the swab was taken, and it showed positive for influenza virus B infection. The patient was treated with TAMIFLU. On an unspecified date, the patient's lab test showed positive for maxillary sinusitis. At the time of this report, the patient had recovered from the events, Influenza virus B infection and maxillary sinusitis. Follow-up received from other health professional (nurse) on 31-Jan-2018: The new events maxillary sinusitis and knee pain were added. The treatment drug TAMIFLU was added. The reporter confirmed that patient did not receive any flu vaccines in past and patient visit was for knee pain. It was reported that patient had no flu symptoms prior to vaccination. Narrative amended accordingly. Follow-up received from other health professional (nurse) on 12-Feb-2018: The reporter confirmed that, the event knee pain occurred before vaccination, hence added knee pain as current condition and deleted from the event section. The outcome of the event influenza virus B was changed from not reported to recovered. Narrative was amended accordingly. Non-significant follow-up received from other health professional (nurse) on 09-Apr-2018: As there was no new information in the source document, no changes were made in narrative.
Woke up a.m. of 10/30/12 w/ severe pain in left arm. Sore to touch but mobility okay if not bearing weight. No discolor but slightly swollen. Had sleeveless shirt on at time of vaccination.
Information has been received from a health professional concerning a 9 year old patient who on 29-JUN-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On 29-JUN-2007, the patient developed redness and swelling at the injection site. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
This patient's mom states that the patient had a lot of pain with the vaccination itself. She had soreness in the arm that evening, the next day the pain radiated to the shoulder, back of the neck and to the top of the back. All pain on the same side the vaccine was given. The pain progressed over the weekend and radiated down the right side. By Wednesday morning (7days later) the pain started subsiding, but then by the afternoon she was hurting in the neck and the shoulder again.
rheumatoid arthritis; first shot made me feel so bad, was on the sofa for a day; never went back for the second; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria medically significant), feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the rheumatoid arthritis, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rheumatoid arthritis and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. Several years prior to the reporting date, the patient got the first vaccine but never got the second.  The patient asked could he/she get the second vaccine now or did he/she had to start all over. The patient was trying to get vaccinations in order before to start Actemra infusions next week for rheumatoid arthritis. The first shot made patient feel so bad that the patient never went back for the second like patient should had. The patient was on the sofa for a day and could not remember exact symptoms. The patient stated way better than having shingles, should had gone back. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient asked were there two shots were same and would it be dangerous to start over and if he/she get the vaccine now, how long should he/she wait before getting an Actemra infusion, was there information on that.
When you get the vaccine.then get shingles/Suspected Vaccination failure; get shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. As per the patient, when you get the vaccine, then you would get shingles and you were contagious and the gave shingles to others. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
The second time it doesn't hurt her as much as the first one; come back in a week to receive the Menactra, Nurse give her to the Trumenba instead so she received Trumenba two dosage a week apart; come back in a week to receive the Menactra, Nurse give her to the Trumenba instead so she received Trumenba two dosage a week apart; This is a spontaneous report from a contactable physician via a Pfizer sales representative.    A 17-year-old female received first and second doses of the meningococcal group b rlp2086 (TRUMENBA; NDC number: 0005-0100-01, Expiry Date: 01Aug2022, Batch/lot number: CN1583); both via an unspecified route of administration on unspecified dates one week apart at a single dose for immunization. Medical history was none, the patient very healthy, no drugs, no alcohol, nothing. Concomitant medications were not reported. When the patient received the first dose she did not want to get meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) at the same time of receiving meningococcal group b rlp2086. When the patient returned after 7 days, they inadvertently gave the second dose of meningococcal group b rlp2086 again instead of meningococcal vaccine a/c/y/w conj (dip tox). The patient experienced pain with both doses, and reported that the second time it did't hurt her as much as the first one. The patient recovered after first dose, was fine.   No follow-up attempts are needed. No further information is expected.  Follow-up (11Nov2020): new information from the same contactable Physician included: patient age, gender, weight and height, clinical course, new event of pain.   No follow-up attempts are needed. No further information is expected.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. On unknown dates these patients were vaccinated with doses of improperly stored GARDASIL (lot # K010215 with expiration 05-MAY-2017, dose and frequency were not reported) (incorrect product storage). The vaccine was stored in the temperature of 33 F (Minimum) and 55F (Maximum) for 12 hours. No adverse event was reported. No product quality complaint was involved. This is one of two cases received from the same source. Additional information has been requested.
COVID 19 Vaccine Moderna 025lZ0A; Vaccine was given in left shoulder and I am right handed. After six days, my left leg swelled up about one inch in circumerece compared to my right leg.  There is no pain. Has anyone else had this issue?
Patient received Gardasil in left deltoid.  Upon standing, patient collapsed, hit back of head on stool to exam table.  Patient loss consciousness for 30-40 seconds.  Patient was treated by nurse (RN) and sent to hospital for staples for scalp laceration.
Had an unexpected and unusual reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (5mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the patient instead of the standard PPD solution.
w/in 4hr p/shot pt began to feel off & squeamish;by 8hrs p/shot pt was vomiting repeatedly & forcefully;had to go to ER:
No indication that this was an adverse rxn to, or result of immun; COD bronchopneumonia;
It was discovered that the vaccine received was stored in a freezer longer than recommended by the manufacturer. Per the manufacturer, since the potency of the vaccine cannot be determined, it's unclear of the level of immunity this dose was expected to deliver. After consulting with our immunization experts, and with the vaccine manufacturer, it's recommended to repeat the dose to ensure full protection.
I drew the vaccine and went to go administer the MMR vaccine to the patient. After I finished I came to my laptop to enter the lot number for the vaccine I gave her. As I entered it I got flagged and saw that it was expired, I quickly went to my manager and doctor letting them know it flagged me and that it expired, and they took the next proper actions.
Patient had a syncopal episode while sitting down approximately 5 minutes after the vaccine was given. The patient fell forward and hit her forehead on the floor resulting in a laceration. Patient was conscious and alert when the pharmacist was alerted to go to the waiting area. EMS was called as soon as rph was alerted. Patient sat in the floor for approximately 15 minutes then moved to a chair for another 10 minutes then left. Her husband and son were with her. Patient was told that EMS was on the way but declined medical attention.
Swelling/pressure noticed first in belly/torso/chest area. By Saturday legs, knees felt heavy and tight to move. By Saturday evening couldn?t bend my left leg completely. Sunday couldn?t straighten left keg completely and knee hurt.
Fever, sorethroat and headache. 10/19: fever resolved, headache persisted, nausea/vomiting; later same day with ataxia, worsening and seen on 10/20, MRI negative; persisted with ataxia and vomiting; admitted for either post-viral cerebellar ataxia or post-vaccine cerebellar ataxia.