chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Appointment scheduled too early for 2nd dose of Influenza. Computer scanner was not working and nurse waiting for restart of computer and scanner. All questions asked of mother while waiting for computer. Influenza dose administered before scanner available. 2nd dose of Influenza was too early for vaccine schedule. No negative outcomes reported.
Information has been received from a pharmacist, concerning an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' medical history or concurrent conditions. Concomitant therapies included sterile diluent (DILUENT MR). On an unknown date in 2017, on or after 23-JUN-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration were not provided) for prophylaxis, and the administered doses were exposed to a temperature higher than 6 F (Fahrenheit degrees) but lower than 17 F (Fahrenheit degrees) for 1 hour (digital data logger) with a previous temperature excursion higher than 6 F (Fahrenheit degrees) but lower than 14 F (Fahrenheit degrees) for 45 minutes. No adverse effects were reported.; Sender's Comments: US-009507513-1708USA010696:
SHORTNESS OF BREATH, HIVES, ITCHY EYES, HOARSENESS OF VOICE.
Pt recv vax on unspecified date; on unspecified date pt exp rash.
Presented to hospital on 3/25 with flank and chest pain after telephone triage referral by PCP office. ER completed CT scan of abdomen and pelvis which showed evidence of wedge-shaped area of non-perfusion involving upper pole of right kidney (renal infarction). Admitted to telemetry floor. Serial troponins negative. ECHO showed apical septal wall hypokinesis with grade 1 systolic dysfunction. Nuclear stress testing showed high risk study, underwent cardiac cathertization which showed patent grafts. TEE negative for thrombus. Hematology labs pending at time of discharge. Unknown etiology of renal infarction at time of discharge.
16 year old male , volunteered with his mother at COVID vaccination event - received vaccination at event. His parents approved of vaccination - he did not disclose age prior to vaccination . Would like to proceed with 2nd vaccination - parents approve . Mother spoke with pediatrician who would like patient to receive 2nd dose. Minor consent to be signed Minimal arm soreness post injection
fainting and patient fell on ground (hitting forehead), 911 was called; the patient came around in 10 seconds or so.  Patient said they felt a little nauseous but then dizzy and things went dark. We kept them laying down on the floor with knees up, took their BP (127/72) and waited for medics to come. Medics arrived within 10 minutes to evaluate the patient, offered to take them to the hospital, patient declined and they released them to take it easy and call them/go to hospital if they felt faint again.
33-year-old WM who received his anthrax vaccine #5 on morning of 1 July 2004 in his left upper arm, towards the triceps. On 7/2/04, when he awoke, the vaccine site was red, warm, swollen, pruritic and tender; the area involved was approximately 2-3" around the vaccine site and almost 1/2 the circumference of his upper arm. He denies any significant systemic symptoms such as lymphadenopathy, fever, muscle or joint pain, or headaches. He has not had a similar reaction with previous anthrax vaccines. The involved area increased in size over the next few days. On 7/3/04, he was advised to treat with atarax and topical steroids for itching, and to take tylenol or ibuprofen for tenderness. On 7/14/04, the tenderness, pruritis and edema resolved, but still a little patchy redness on inner, upper arm just above the elbow; no streaking.
Administration of only the adjuvant; Administration of only the adjuvant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administration of only the adjuvant) and inappropriate dose of vaccine administered (Verbatim: Administration of only the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 06-APR-2023 A vaccine coordinator called in to report that 2 out of 10 patients that received the AS01B adjuvant only of Shingrix. The reporter asked if the patients had to receive a properly reconstituted Shingrix dose. The reporter mentioned that they were not able to identify who the 2 patients were who received the AS01B adjuvant only. Therefore, the reporter did not provide patients identifiers as well as vaccine data (lot number, exp date, date of administration). The reporter consented to follow-up. The case was linked with case US2023AMR051204, reported by same reporter for different patient. The patient received the AS01B adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023AMR051204:Same reporter
Swollen lips & tongue, primary MD said pt did not need to be seen and advised pt to get BENADRYL OTC.
She has been having watery eyes and itching in her eyes which started about eight days ago which turned into head congestion with a runny nose, sore throat and a cough. She is just not feeling well. No fevers or chills. No chest pain or shortness of breath.  starting 10/29/21
The second Moderna  vaccine produced an angry red knot at the left arm injection sight that grew into intermittent stabbing pain.  I became  lethargic then  grew weak to the point  I could not sit up straight and slept almost all day.  I developed a massive headache that radiated down to the top of my neck and loss of appetite.   My lymphatic system was in overdrive.
Rash in her arm; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in unknown arm. The patient experienced rash in her arm. The permission to follow up was denied.
feeling a little rough; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling a little rough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feeling a little rough). At the time of the report, FEELING ABNORMAL (feeling a little rough) had not resolved.
nausea; SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics (Reaction after Shingles vaccination.) since 2016 and Anaphylaxis since 1981.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced NAUSEA (nausea). On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM). The patient was treated with ONDANSETRON HYDROCHLORIDE (ONDANSETRAN) from 13-Mar-2021 to 15-Mar-2021 for Nauseous, at a dose of 8 mg every eight hours. On 15-Mar-2021, NAUSEA (nausea) had resolved. At the time of the report, VACCINATION SITE PAIN (SORE ARM) had resolved.            No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-023319, MOD-2021-023319 (Patient Link).
Miserable, no interest in eating or playing with toys. "Red thigh and not sleeping through the night"
Erythematous rash around injection site (65 x 100 mm); warm at touching. Looks like a cellulitis vs a sterile abscess.
Mom reports inc temp w/use of APAP from 6PM (102 R) to 5AM (105.4 R), temp @ ER 105.8 R; MD notified w/instructions & dec temp to 102.6;
felt tired; headaches; myalgia; chills; slightly elevated body temperature; Fall asleep around 13 hours and woke up around 16 hours; fever; not able to sleep all night; This is a spontaneous report from a contactable consumer(patient). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP6955 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:30 (at the age of 33-years-old) at dose 2, single for covid-19 immunization. Medical history included muscle aches. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have allergies to medications, food, or other products. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 10Mar2021 09:30 (at the age of 33-years-old) at dose 1, single for covid-19 immunization. The most recent COVID-19 vaccine was administered at workplace clinic. It was reported that patient was good in first 12 hours after vaccination. Later on 31Mar2021 22:00, patient experienced chills and slightly elevated body temperature, fall asleep around 13 hours and woke up around 16 hours and also had fever and myalgia, was not able to sleep all night and relived all muscle aches he had over last couple years. After 24 hours (01Apr2021 9:30), patient felt tired and had headaches. At 36 hours, chills came back but only stay around half an hour. At 48 hours, only leftover headache left. No treatment was given for the events. The outcome of the events was recovered on 02Apr2021.  No follow-up attempts are needed. No further information is expected.
Began with "spots" and itchy vesicles began 4/8/03. 4/9/03 multiple red papules, vesicles 40-50 on torso. 20 on extremities; some on palms, soles and oropharynx. Afebrile, no resp. sx.
Information has been received from a physician referring to a 10 years old male patient. The patient had no pertinent medical history and no known drug allergy. The patient had no serious illness, no colds, no viruses and no medications in the months preceding the vaccinations. On 06-OCT-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot # L007560 with unknown expiration date, 0.5 ml) intramuscularly in the left arm. The patient was also vaccinated with BOOSTRIX and FLUMIST on the same day of 06-OCT-2015. On 16-OCT-2015, the patient experienced rash. The rash was indurated itchy, painful, purpura lesions, about 2 millimeters by 3 centimeters and red with white centers. The rash was found on the palms of his hands and soles of the child's feet. The rash was also on his thighs (which look like bulls eye target) and on his extensor elbows, knees and left eye lid. The physician stated there was very little rash on the torso and none on the buttocks. The physician also stated it was like an immune-medicated skin rash. In the evening of 18-OCT-2015 the patient was seen in the physician's office. After midnight, the child was seen in the office to offset an emergency visit. The physician stated it appeared the patient had erythema multiforme minor. The physician also stated the child did have complaint of some shortness of breath (SOB). However, physician stated he felt the SOB was anxiety based, since there was no cardiovascular, no respiratory or joint involvement. The child was given prednisone (20 mg, twice a day oral) for 3 days for treatment. The patient was not hospitalized and was not recovered from the events. The causality was not reported. Additional information has been requested.
numbness in the tip of my tongue; exhaustion; headache; low grade fever; arm pain; itching of arm of injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8736) on 17May2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to eurythymacin. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 at 13:30, the patient experienced numbness in the tip of her tongue, exhaustion, headache, low grade fever, arm pain and  itching of arm of injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events numbness in the tip of tongue, exhaustion, headache, low grade fever, arm pain, itching of arm of injection site was recovering.   No follow-up attempts are possible. No further information is expected.
Chronic Urticaria (Hives)  Have to take 5 different allergy medications (Allegra in the morning; Zyrtec, Pepcid, and Singular in the evening and when hives are extreme had to take prednisone to try to control the daily hives.  Have been hospitalized several times when the hives could not be controlled.  Was given epinephrine when hospital visit was necessary.
Started having muscle jerks  all throughout the day.  Also experienced muscle twitching.  Went to a neurologist, had mri of brain, eeg of brain and blood work for brain tumor. All negative. Went a second time and the neurologist did more bloodwork for vit e, calcium, magnesium and vit d deficiencies. All negative. I am still to this day experiencing these issues.
Back ache, eyes burning and bloodshot, tongue swollen, blisters in mouth,chills.
3rd dose (booster), no side-effects at all for previous shots. Booster was Friday afternoon, all was normal. Then on Sunday, was yawning a lot in afternoon, and mentioned having a hard time breathing. Took him to Dr on Wednesday because he also mentioned a headache, kept mentioning breathing difficulties (and it was visible at this point, both indoors and outdoors), and was definitely yawning throughout the day. Couldn't sleep last night because laying down was too hard to breathe. Not distressed, but breathing does require visible effort (it's harder than it should be). No other symptoms. Monitoring.
A 44yo, female, who eventually presented to the ER on 10/26/2014 with pain and swelling on her right shoulder after receiving both a flu and PNEUMOVAX in the right arm on 10/21/14. Patient had reported back to clinic on 10/23 and 10/24 with localized redness and swelling at injection site. Patient reported she had a fever on 10/22, she Ibuprofen which helped with the fever but the pain/swelling persisted. At the ER the patient reported unbearable pain, feeling feverish, nausea, vomiting, SOB. No cough. TX with heat/ice/naproxen/steroids.
Began to feel numbness, lack of sensation and loss of strength to the left limb from the waist down. Also noted weaker grip strength to the left hand. Loss of bladder and bowel control. This persisted throughout 2/5. On saturday 2/6 the right leg began to feel weak and numb as well although not as severe as the left limb. He was admitted to the hospital on Saturday evening, 2-6
Tingling throughout entire body 15 minutes after vaccination; This is a spontaneous report from a non-contactable pharmacist. A female patient of an unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an intramuscular route of administration in the left arm on 10Apr2021 at 12:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that the 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 had not been tested for COVID-19. On 10Apr2021, the patient experienced tingling throughout entire body 15 minutes after vaccination. It was reported that the event did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with BENADRYL. The clinical outcome of the event tingling throughout entire body 15 minutes after vaccination was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
t103+, crying/fussy/sleepless, nausea, anorexia w/in 12 hrs of vax;
vomiting with fruity odor, BG 417, weakness & SOB, Torsade de pointe & received CPR, DKA, sepsis, lactic acidosis
Information has been received from a nurse practitioner concerning her mother who was vaccinated with a dose of PNEUMOVAX 23 approximately 5 years ago. It was unknown if the patient had a reaction to that dose. The patient also received a dose of PNEUMOVAX 23 approximately 1 year ago. The patient had a significant injection site reaction including cellulitis. The patient sought medical attention. At the report time the patient had recovered. No further information is available.
DID NOT REFRIGERATE AND TOOK VIVOTIF; A spontaneous case report was received from a pharmacist on 28-May-2019 for two consumers.  Based on the information obtained from the pharmacist, two individual case safety reports PVX201905-000431 (PVX2019-1351; 42-year-old female) and PVX201905-000432 (PVX2019-1352, 14-year-old female) were created and cross-linked in the database.  This case describes a 14-year-old adolescent female consumer who "did not refrigerate and took Vivotif". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer did not refrigerate Vivotif doses for 3 weeks and completed the course of it.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not refrigerate and took Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not refrigerate and took Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000431:
Warm, hard bump on upper (L) thigh, fussiness and not putting weight on leg to crawl. Tx by massage or warm pack.
severe headache started the night of 2nd vaccine. After 6 days I called for a phone appointment. Dr prescribed a toradol shot and relafen. I was unable to get the toradol shot -( they said it would be 10 days to be able to get in) but headache went away within 2 days of the relafen
9am 1/12/21 started low grade temp which lasted 24 hours.  Late night 1/12/21 started with headache and body aches lasting through to  1/14/21. 1/14/21 nauseous and fatigue.
Severe generalized body/muscle ache for the rest of the day.  The injection site was definitely sore and hurt the most. I didn?t take any medicines or supplements thinking that it?s just my body building immunity against COVID-19. The symptoms subsided the next day, injection site still a little bit sore but better than the day before.
fever; body aches; chills; shaking; underdose; exposure via skin contact; Inadvertent exposure to vaccine; arm is still sore; This case was reported by a nurse via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for 1st dose, refer case US2019135644).   On 22nd July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On 22nd July 2019, the patient experienced fever, general body pain, chills, tremor, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, general body pain, chills and tremor were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved and the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the fever, general body pain, chills, tremor and pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who herself was a nurse. The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient had the injection during morning. By night the patient was experiencing fever, chills, shaking, body aches. The patient did not have those symptoms anymore but her arm was sore.  Fluid ran out of her arm after she received the Shingrix so she was concerned about not getting the complete vaccine. The reporter did not give consent to follow up. This case has been linked with US2019135644, reported for the dose 1 of the same patient.
about 25-26 hours after the vaccination, i was feeling fine then instantly started getting dizzy, foggy, my ears seemed to stop working, like i had my head wrapped in a pillow. i could still hear but it was like the volume had been turned down, and there was a buzzing in my ears.  I also had the cold sweats,nausea and almost threw up.  These all lasted about five minutes, then everything went away, and i was fine.  I have been fine ever since.
Patient felt like patient had the flu; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Patient felt like patient had the flu) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Patient felt like patient had the flu). At the time of the report, INFLUENZA LIKE ILLNESS (Patient felt like patient had the flu) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  The reporter reported that after 20 hours of receiving the second dose, the patient felt like the patient had the flu.   This case was linked to MOD-2021-406574 (Patient Link).