chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; Headache; Fever; Body ache; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 06-Dec-2020.  This case involves a patient of unknown demographics who got sick (Illness), headache (headache), fever (pyrexia) and body ache (Pain), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient got sick (Illness), headache (headache), fever (pyrexia) and body ache (Pain) for 2 or 3 days, with the INFLUENZA VACCINE afterward.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown and reported that the patient get normal again after 3 days.  There will be no information available on the batch number for this case.
Same day of shot (4/24/2021) I had soreness around the injection area which is still sore today (04/26/2021). Also, yesterday (04/25/2021) I felt dizzy, like I was going to faint, and my body felt drained of energy.  I took four naps which I never take so many naps in one day. As of today, I still have the soreness in my arm, but the other symptoms seem to have gone away at least for now.
Around  6:05 PM after my first shot on Aptil8,2021 I experienced extreme muscle pain in my left shoulder area, then days later I noticed a big black bruise on the back of my right elbow and more arm muscle weakness and soreness. My second shot is due on May 5, should I still take it or not?
seen in ER on 26OCT92; t104.9 R & vomiting tx w/APAP & Advil; ER MD said no pertussis next time; felt it was due to vax; t102.3 ax x 2 days; given baths; had ear infect 4 days later;
got the vaccine, had shingles twice/Suspected vaccination failure; shingles/got the vaccine, has had shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Oct-2022 Reporter's comment: The case was received from the patient's children via interactive digital media.  The patient got the vaccine and has had shingles twice since then. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
An adult patient (who had already received monovalent COViD-19 booster vaccine dose) came in to our clinic to receive their bivalent COViD-19 vaccine booster dose.  A monovalent booster dose was accidentally administered to the patient by a staff MA instead of the bivalent vaccine. Patient was notified of the error. Patient advised to monitor for any adverse symptoms.
This case was reported by a physician via a sales representative and described the occurrence of chronic hepatitis b in a 18-year-old male subject who was vaccinated with hepatitis b vaccine recombinant (manufacturer unspecified). On unspecified date as a child, the subject received a hepatitis B vaccine series (the total number of doses received and the schedule for immunization was not reported). In 2011, within years of vaccination with hepatitis B vaccine, the subject "contracted" chronic hepatitis B. The specific date of onset was not known, but was picked up on a hepatitis panel (date not provided). The physician conveyed that this could be possible vaccination failure. No other events were reported. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with hepatitis B vaccine. It was additionally reported that the subject's 22 year old brother also contracted hepatitis B following a hepatitis B series as a child. The brother's case number is A0954205A. All other members of the subject's family including the mother, father, and sister were negative for hepatitis B.
Moderate vertigo within 24 hours of receiving Pfizer booster. 4 weeks later awakened with sudden RIGHT ear severe hearing loss, aural fullness, and severe tinnitus. LEFT ear with steady mild tinnitus. Saw Nurse Practioner at allergist who prescribed prednisone and azithromycin, Xyzal, Mucinex, and Flonase. No improvement with treatment and returned to the office and received an additional steroid course. No improvement and sent to ENT. ENT ordered audiogram/tympanogram and MRI. An audiogram revealed moderately severe reverse ski-slope hearing loss RIGHT ear in low frequencies. MRI was within normal limits and revealed no structural issues. ENT sent me to Ear Clinic where I was diagnosed with Cochlear Hydrops and prescribed HCTZ and Potassium chloride, vestibular exercises, and a change of diet to avoid tyramines.
Pain at the shot site; Swelling at the shot site; Headache; Blurred vision; Nausea; metal taste in mouth; Irritability; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 25Apr2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy, and gluten sensitivity. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); taken for unknown indication on an unknown date and unknown if ongoing. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug 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. On 25Apr2021, the patient experienced pain and swelling at the shot site, headache, blurred vision, nausea, metal taste in mouth, irritability and fatigue. It was unknown whether therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of pain and swelling at the shot site, headache, blurred vision, nausea, metal taste in mouth, irritability and fatigue was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Immediately following vaccine I experienced rapid heart rate, small tightness in chest, and shortness of breath. I had to remove my mask to breathe. I stood from feeling my heart race, but then felt dizzy and sat again. It felt exactly like what happens when I eat shellfish, only it eased faster. Symptoms improved after five minutes of deep slow breathing.  My heart raced longer, than five minutes but were not bothersome after five minutes.  The attendant watched me the full half hour and was prepared with epinephrine if my airway swelled. He offered me benadryl, but i took it at home instead. That night my neck swelled slightly around my thyroid and my throat felt itchy. . I took two Benadryl and went to bed. Today the right side of my face is slightly numb, but moves normally and is not drooping. I have had bells palsy immediately after 2009 H1N1 vaccine, and same allergic response hr and breathing after varicella vaccine. All other vaccines have not been a problem.
6-8 wks painful, swollen arm w/ecchymosis for 8 wks-believes also had low grade fever-however undocumented;
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 52 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular at 0.5 ml.. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored PEDVAXHIB (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This 21 year old patient received primary Smallpox (VV04-003A), Anthrax #1 (FAV328A), and IM Typhoid (H1482) vaccines on 11/13/2013. He received seasonal IM influenza (007011A Novartis) on 11/6/2013. He denied any adverse reactions to these vaccinations with medical records documenting a major take at his SPV site. On 12/30/2013 after traveling home; he began to complain of stomach ache with nausea, vomiting and diarrhea (brown-clear liquid) that night. By 6 am 12/31/13 his vomiting had stopped and his diarrhea ceased on 1/1/2014. He denied fever, sweats, or eating any new foods, seafood, and family was not ill (ate similar food at home). He awoke 1/2/2014 with a burning 8/10 pressure to mid chest and could feel his heart beating, his jaw was tight as if he'd just chewed or clenched teeth, and had tingling pain to left >right shoulder. He vomited once and had dry heaves. He stated it hurt to breathe deep but no shortness of breath. Position changes did not affect the pain. He drove himself to nearby facility and was referred to nearby hospital. At the ER his EKG showed NSR with 1mm ST depression V4-5, normal CXR, and elevated cardiac enzymes: CK 391 (H), CKMB 13.5 (H), CK% 3.4, Troponin POC 0.56, Troponin T 0.19, normal BMP, CBC, PT and INR. His pain was treated with ASA, 1L NS bolus and one NORCO 5/325 with pain easing to 2/10 (like a sore muscle in his chest). He was transferred and admitted. That evening about 7pm his pain again worsened to 8/10 as dull intense chest pain without nausea or radiating pain. His EKG remained in NSR and he was treated with MOTRIN and colchicine with minimal relief of pain. One PERCOCET resolved his pain (0/10). He was started on routine IV then oral NSAIDS with no reoccurrence of pain as of 1/7/2014.
Patient received yellow fever vaccine.  Approximately one hour later patient developed swelling of the tongue.  Patient took Benadryl (PO).  Swelling lasted for approximately 2 hours.  The next morning at approximately 8:30 am, patient ate eggs and his eyes became red and swollen.  Symptoms lasted until 4:30 pm.
Irritation on inside of upper and lower lips with some swelling.   Very dry and scratchy throat.     By 11:00 PM the lower lip was much better.    This morning 1/24  lower lip not an issue but upper lip still irritated and swollen on inside of lip.     Very dry but no sore throat
As per patient " On 2/23/21, after receiving the second dose of Moderna, I experienced on 8/22/21, a Guillain-Barre Syndrome episode. On that date, upon arising from bed my right leg gave way and I fell to the floor, I was not able to feel any sensation in that leg whatsoever. After massaging my leg, feeling returned. I experienced much pain in my right knee and I was not able to stand on that leg. Even two weeks later I am not able to apply normal pressure on the leg without feeling pain in my knee. "
Patient age 16 was given Janssen (J&J) vaccine.  Age for Janssen is 18.
pt recv vax 19DEC95 & 11MAR96 devel vesicular, erythematous rash on rt shoulder w/edematous eruptions in the C2 distribution;an exam revealed that condition was consistent w/shingles;Tzanck smear was positive for multinuclear giant cells;
Constant headache, fever of 100.5, full body aches, dizzy, nauseau, fainting, loss of appetite - all between 930pm and 3pm of next day.
I had a problem with my ear right ear and clogged for some reason, dizziness with vertigo, fogginess and had some slurring of speech during the months after, not sure though just checking in because I don't have allergic reactions to any vaccines ever.  I think we need them so I am reporting to ensure this is not the case.  I took antihistimine and the nasal type also to clear because I was not sure what it was I think allergy.
MY TONGUE IS NUMP AND TINGLES WITH NO TASTE  SWOLLEN GLANDS SINCE THE 1ST DOSE NO SMELL  AND SERVERE HEADACHES WITH ALLERGIES
This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-MAR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 632 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Large patch of redness and swelling and hardness at injection site.  After three days, bruising appeared.  After five days redness and swelling subsided but bruising became darker.
?Patient received a dose of Moderna COVID 19 vaccine after 2 previous doses of Pfizer.  Patient refused vaccination due to personal reasons on 02/20/21.  Patient agreed to the vaccine at a later date and denied COVID 19 vaccine history or any treatment to COVID-19. Patient was given the Moderna vaccine on 04/01/21. Prior to the scheduled second Moderna dose, the nursing home informed the clinic that the patient was previously vaccinated.  1/14/21 Pfizer Lot # EL3249 2/4/21 Pfizer Lot # EN5318  No adverse symptoms to report.
RHEUMATOID ARTHRITIS FLARE UP; SICKNESS; FOGGY FEELING IN HEAD; SORE NIPPLE; PARESTHESIA OF FINGERS; This spontaneous report received from a patient via a company representative via other company concerned an adult male of an unspecified race and ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Humira, adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry date were not reported) dose was not reported (Citrate free), 1 time every 1 day, therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced rheumatoid arthritis flare up for couple of days, sore nipple, and paresthesia of fingers. On an unspecified date patient had sickness and foggy feeling in head after covid-19 vaccine shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from rheumatoid arthritis flare up, sickness, and foggy feeling in head, and had not recovered from sore nipple, and paresthesia of fingers. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220737605-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis flare up. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Felt headache and fatigue on 1/27/21, left work at noon, symptoms resolved by AM on 1/28/21.
This case was reported by a pharmacist via call center representative and described the occurrence of neurological symptom in a 54-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020) for prophylaxis. On 24th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 1st March 2018, 36 days after receiving SHINGRIX, the patient experienced neurological symptom. On an unknown date, the outcome of the neurological symptom was unknown. It was unknown if the reporter considered the neurological symptom to be related to SHINGRIX. Additional information was reported as follows: This case was previously reported to the physician. The reporter was the patient himself, after vaccination with SHINGRIX, he experienced neurological symptoms and till the time of reporting, the patient was still experiencing the events. The reporter provided permission to contact his physician. The reporter did not want to take time to elaborate on the neurological symptoms. The reported batch number 324KL, does not exist in the sales database, so it was replaced and corrected with the correct batch number as 3Z4KL. It was unable to obtain further information.
Case number PHEH2014US003677 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 7-years-old female patient. Her medical history and concomitant medications were not reported. It was reported that this patient under 18-years of age was vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) intramuscularly at a dose of 0.5 ml on 13 DEC 2013. No adverse events were reported following the maladministration.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
I started having shortness of breath and went to the emergency room.  It was determined I had blood clots in both lungs and I was prescribed blood thinners for the next 3-6 months
Accepted vaccine in the left arm at 2:30 PM on 03/12/2021.  At approximately 10 PM same date begin feeling headache along with body aches.  At 2 AM on 03/13/2021 awaken by flu-like symptoms - body aches, headaches, night sweats, weak muscles  Same flu-like symptoms continued until the next day 03/14/2021 until 6 PM, some relief but a headache and weak muscles continued.  At approximately 10 PM on 3/14/2021 symptoms continued as headache, right ear began to have pain associated like an ear infection and upper jaw/teeth were throbbing until approximately 6 AM on 3/15/2021.  Waking on 3/15/2021 around 7:30 AM only a headache persists and slight muscle weakness.
This spontaneous report as received from a consumer refers to a 70 year old male patient with diabetes. On an unknown date the patient was vaccinated with ZOSTAVAX for shingles vaccination and developed flu symptoms and headache. The outcome of flu symptoms and headache was reported as recovered. The relatedness for flu symptoms and headache was not reported for ZOSTAVAX. Additional information was not expected.
The vial had been at room temperature 40min past the 24 hour rule. An unpunctured vial at room temperature must be used in 24 hours. Provider and Patient were made aware, patient has decided to not receive another repeat dose at this time.
Patient received a typhoid vaccine, and within 5 minutes after patient started vomiting, not acting right was standing by mom and froze with hands up. NP requested PCT to call the squad, NP went to pharmacy to get pharmacist for help, Came back to the room, patient is sweating, decided to give the patient a shot of benadryl, 0.25 mg IM, Squad arrived and assessed patient o2 sats were good, lung sounds good, recommended that he be checked out at the ED, mom refused transport. Educated mom on watching patient for the next few hours. She agreed.
He was tested positive on the covid-19 virus this week on April 21, 2021; This is a spontaneous report from the Pfizer sponsored program Covax US support. A contactable consumer (Patient) reported a unspecified age of male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 13Apr2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19 with swab test and resulted positive on 21Apr2021. It was reported that the patient called to advise that he and his family had their first dose of the vaccine last 13Apr2021. He was tested positive on the covid-19 virus this week on 21Apr2021. Caller also stated that he himself tested negative on the Rapid test but since his Doctor advised for further test since he was in the proximity of others who tested positive to get a deeper swab test which then turned his result as positive again. Caller wants to know if they still need to go through the second dose of the vaccine scheduled on 6May2021. The outcome of the event was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Diagnosed with shingles on 18Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Diagnosed with shingles on 18Mar2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary embolism. Concurrent medical conditions included Pre-diabetic and Blood pressure high. Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced HERPES ZOSTER (Diagnosed with shingles on 18Mar2021). At the time of the report, HERPES ZOSTER (Diagnosed with shingles on 18Mar2021) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  The patient subsequently reported he was doing well.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: TCR : AE outcome
Pt called office 7/13 evening to report chills, fever, stomach upset, headache the night following her Shingrix vaccine (7/12). Pt then developed a red, swollen, hard lump at the injection site.  RN called pt in 7/14. Pt reported swelling and redness had slightly decreased in size/appearance. Headache had improved. Pt denied fever/chills. Pt endorsed mild stomachache and nausea, denied emesis.  RN advised pt to continue to monitor s/sx, treat with OTC Ibuprofen and/or Acetaminophen as needed, take Ibuprofen with food to prevent GI upset. Advised pt to seek medical care/evaluation if s/sx worsen. Pt's PCP notified and aware. Pt travelling internationally on 7/14, given ISOS information by MD and RN. Pt verbalized understanding and in agreement with POC.  No further follow-up from pt at time of this submission.
Fever 100.2 F, chills, congestion, headache, ache over whole body, particularly bad in back and knees, soreness at vaccine administration site, and pain in vaccine administration arm.