chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given 8am 2/13/23, redness and swelling at site of Dtap/IPV at 8am 2/14/23 and lingering by 2/15/23 - no pain, no itch - hive like at times. no overlying blistering. eval on 2/15/23 with a 7.5cm diameter area of redness and swelling with induration at site of injection 2.5cmx3.5cm and slight blanching.
Less than 5 min post vaccination today, he felt dizzy. No fall incident. Staff was able to assist him onto the floor. He was alert and oriented x 4 in NAD.   Dizziness resolved in less than 1 minute. After 25 minutes of observation he was well and active. His wife is with him. He was discharged from vaccination site
"pt recv vax 29AUg96 & 5SEP96 pt exp fever, macular rash on trunk, swelling @ the site of inj, arthralgia in thumb & knee, h/a, neck stiffness & felt like had a hangover;13SEP96 had completely recovered;"
booster; lymph nodes swelling under the armpit where the shot was given.; painful; swollen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from License Party. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 29Oct2021 (Lot number: 3203080) as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 29Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, Manufacturer- Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Oct2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "lymph nodes swelling under the armpit where the shot was given."; PAIN (non-serious) with onset 2021, outcome "unknown", described as "painful"; SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swollen."  Additional Information: Regulatory authority notified was unknown. No report of exposure during pregnancy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up with slight light-headed or wozzy feeling. Temperature slightly lower (96.5) than normal (~97.2). 6 hours later, light-headedness has mostly dissipated. No treatment othe rthan drinking water.
Redness, warm, "rash" at site of injection about the size of a finger tip.
Fever and leg pain on night of vaccination, difficulty sleeping at night two days after vaccination, Fever continues, Swelling of inguinal lymph glands about 7 days post vaccination, Fever of 100.0 on 03/26/15.
Pt c/o Left side facial numbness  from eye socket to chin  noted after he got home from receiving the second Covid vaccine on 4/27/21. This started on Tuesday but is now beginning to diminish. No effects  to vision , smell, taste or hearing,  Pt did not have any drooling or numbness inside mouth or bite marks. No tingling on scalp or neck area,  only front facial numbness, no other numbness on body occurred.
Administration site was not in the muscle/deltoid. Administration side was mid upper arm. Cellulitis with distinct edges noted measuring 6 cm x 3 cm with pain, pruritis, and erythema.
2 days after 7/31, patient experienced pronounced pain on area below the bridge of nose to halfway down nose for 1 week she took ibuprofen but didn't respond to it. She thinks pain may have started on 7/30 but wasn't too noticeable.
About three days after getting his third dose of Polio (IPV) and fourth dose of Hib, patient developed a rash, mostly on his legs, and concentrated behind his knees.  It was not itchy.  It consisted of bright red patches of rough, dry skin, from below dime-sized to about half-dollar sized.  His neck was also a little red and rashy-looking, but not in patches.  He has been prone to rashes since the age of 2 months, when he recieved his first vaccine.  There was no treatment, since he didn't seem bothered.  The rash very slowly diminished, with occasional new patches appearing.  It has been more than a month since the shots, and the rash is still noticeable, though mostly restricted to the area behind his knees.  His neck is still a little red as well.                                         I do not know the manufacturer for the vaccines - I picked the first one because I could not submit the form without it.
I had a SHINGRIX (shingles vaccine yesterday). 2 hours later I developed a little fever (100 degrees) and my arm was swollen and in pain. I could barely move my arm. I took ALEVE to relieve it. Woke up fine, though my stomach was a little upset. As the day progresses, I started to feel worse, sharping body pain (back, legs, arms, neck) shivering, headache, minor fever, arm pain.
rash appeared at the site; peeling of skin; tenderness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number Z9E99, expiry date 2nd June 2021) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced injection site tenderness. On 1st July 2019, the patient experienced injection site rash and rash desquamating. On an unknown date, the outcome of the injection site tenderness, injection site rash and rash desquamating were not recovered/not resolved.   The reporter considered the injection site tenderness, injection site rash and rash desquamating to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient stated that, 72 hours after vaccination, experienced rash appeared at the site, later began to peel. The pharmacist suspected the patient may have let a bag of frozen peas lay on the area too long. The peas were suggested as a way to reduce site pain. This case is 1 of the 2 linked cases, reported by same reporter. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
fever (spiking at 101.7), vomiting, body ache, heart racing and blood pressure raised
immunity went down; always get sick/ got sick like many times like 8-9 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 16Oct2021 as dose 2, single (Lot number: FH8020) at the age of 37 years for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: BNT162b2 (Dose 1), administration date: 18Sep2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: ILLNESS (medically significant) with onset Oct2021, outcome "not recovered", described as "always get sick/ got sick like many times like 8-9 times"; IMMUNOSUPPRESSION (medically significant) with onset Oct2021, outcome "not recovered", described as "immunity went down". The events "immunity went down" and "always get sick/ got sick like many times like 8-9 times" required physician office visit (hospital, urgent care). Therapeutic measures were taken as a result of illness and included antibiotics. Clinical course: The patient already had his first and second dose (COVID-19 vaccine) and after getting vaccinated he experienced side effects of the vaccine. He mentioned that his immunity went down and he always get sick. He stated, "My immunity just went down and it's been long time, it's been more than 6 months, I think October last year (Oct2021). I got sick like many times like 8-9 times. I just need to know what I need to do and no one helps me. I need to know the way out. I think I will have to report and you know every time I go to the hospital the urgent care, whatever I am spending lot of money. This is not what I expected, I was expecting the prevention." Regarding treatment, the patient stated, "I have been sick like many times as I explained. I had some sickness but it was like a months ago. I can't remember the medication, some kind of antibiotics(Further not clarified)."
Vomiting second day morning followed by rash on face around eyes. Rash subsiding but left eye has blood hemorrhage ( blood shot eye). 24 hrs later second eye also blood shot. Tightness of chest also started third day but now improving. No discharge from eye, no discomfort as of now.
Patient has a history of allergic/anaphylaxis reaction in past. Patient did bring her epi pen today to use if needed.   Safety questions  Reviewed. Yes to severe allergic reactions in past but reviewed with provider and ok to proceed. Epi pen present.   Vaccine given to patient and instructed to wait 30 minutes. After about 10 mins patient stated she felt like it was hard to take a breath and her heart was racing. Patient was very flushed and starting to sweat. Heart rate was 154, oxygen 100, and blood pressure 178/100. Patient also feeling dizzy but denied Provider called into room at this time.   VS retaken at this time. HR 100, oxygen 100, and blood pressure 150/80. Order received for EKG. Patient very dizzy, complaining of a headache, and nauseous.  Completed and given to provider for review. Patient still very dizzy when sitting up. Laid patient back down at this time. VS taken again 134/74 HR 88. Stating she is still nauseous and dizzy. No complaints of facial swelling or difficulties breathing at this time. Provider back in to assess patient. Continue to monitor. Dizziness still present.   Patient now itching. Started on her right arm now all over including her face. No difficulties breathing, lip, throat , or tongue swelling at this time. HR 110, oxygen 100, BP 150/80. Provider back in room. Orders received for 50 mg of oral Benadryl to be given at this time.   Decision made to have patient go to ED for further monitoring and evaluation. EMS called at this time.
Pt recvd 2nd dose of Hep B on 22OCT91 & devel dizziness & nausea; On 11NOV91 recvd PPD; @ time of report pt remained under tx;
Information has been received from a pharmacist concerning a patient who on 25-JUN-2012 was inadvertently vaccinated with a dose of VARIVAX (Merck) (Lot #, dose and route not reported) instead of ZOSTAVAX (Merck). No symptoms reported. It was not known if the patient sought medical attention. Follow-up information has been received from a pharmacist stated that she was told by the assistant that the patient came in to the office stating the physician told her she needed the "chicken pox vaccine" so the patient was vaccinated with (Merck) VARIVAX. The health care professional contacted during telephone follow-up could not supply the following information: dates of vaccination/therapy, dose number. lot number, date of event, and recovery status. Additional information is not expected.
1) Sudden strong dizziness and vertigo approximately two hours after receiving the vaccine. Had to lay down for a few hours. After a few hours feel much better but still somewhat dizzy.  I did not have anything like this after the 1st and 2nd doses of the same vaccine, and I am not sure if I ever experienced anything similar.  2) Mild pain at the injection site - started about the same time as dizziness.
On Friday afternoon 1/7 after receiving the vaccine, I felt fairly normal but tired. On Saturday morning I woke up and felt tightness in my chest and a burning sensation in my heart muscle, as well as heart palpitations and a heart fluttering sensation. These symptoms have continued unabated, it is now 6:00pm on Sunday 1/9/2022. The symptoms are exacerbated by exercise.
Information has been received from a physician, concerning who patients (gender and age not specified), who in June 2007 ("within the past week"), were vaccinated, with a dose, of PNEUMOVAX 23 (lot # not provided, though specified as different lots). After an unknown duration of time following the vaccination, the patients developed cellulitis. Follow up information from the physician indicated that there were 5 "serious injection site reaction with (PNEUMOVAX 23) since March." At the time of this report, the 3 patients included in this report had recovered with outpatient treatment (treatment not specified). The physician considered the injection site reactions to be serious, as other important medical events. Additional follow up information from the physician, identified a patient (gender and age not specified), who was vaccinated in the right tricep, on 15-MAR-2007, (a "low titer" was drawn on 08-FEb-2007) with a dose of PNEUMOVAX 23 (lot #655291/0985F). Five hours after the vaccination, the patient developed the start of an injection site reaction, also specified as cellulitis, that involved redness and swelling of the right tricep, chills and a headache. The reaction site was measured as 11 cm by 15 cm. Treatment included ALLEGRA, and the patient recovered (duration not specified). Additional information is not expected.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: Kept patient for additional observation, took 2 doses of Benadryl 25mg PO
Initial unsolicited report received from a pharmacist on 10 October 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of Flu vaccine (Batch number, expiry date, route and site of administration not reported) on an unspecified date couple of year ago. The patient's medical history was not reported. Concomitant medications was not reported. On an unspecified date, two weeks following the vaccination, the patient had experienced Bells Palsy. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: Bell's Palsy. List of documents held by sender: none. Sender's Comments: Bell's palsy was suspected in this case after vaccination with INFLUENZA VACCINE of unknown manufacturer however diagnosis was not conformed. Time to onset two weeks is compatible with the role of vaccine. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies and patient's history of reaction after previous vaccinations are needed to further assess this case. Based on information role of vaccine cannot be assessed.
SWEELING OF LIPS AND FACE.  She started Benadryl 2 days after but after 2 doses the swelling increased.  Saw the doctor who gaver her an injection (forget the name) and the predsolone med pack.  The swelling started to go down 2 days after taking this medication. A week after taking the Moderna vaccine and taking this medication her swelling was gone. Medication was started on Wed Jan 21,2012 and completed on Tue Jan 26, 2021. The swelling didn't get life threatening but when we noticed that inflamation was worsening and Benadryl didnt work we worried and she went to see the doctor for the treatment described above.
Pt called approximately two hours after receiving a pneumonia vaccine with c/o local swelling of arm with redness and tenderness.  She was instructed to use ice and otc analgesics and to observe for any worsening sx such as angioedema or dyspnea.  Pt came in to clinic in am approx 18 hrs after the administration with c/o of worsening redness and swelling and tenderness.  No dyspnea or angioedema of mouth or lips. Pt was afebrile.
hearing loss; other zoster-related injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-NOV-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a physician at the physician office for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). Subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the patient was treated by a physician for hearing loss and other zoster-related injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was not recovered. The events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, hearing loss was considered to be medically significant.
Patient received FLUVIRIN MDV TIV 2015-2016 on Thursday September 24th and reported seizure on Saturday 26th.
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown aye and gender. Pertinent medical history and drug reactions/allergies were not reported. On 01-JUNJ-2015, 08-JUN-2015, 22-JUN-2015 and 20-JUL-2015 the patients were vaccinated with improperly stored doses of M-M-R II (lot # K024038, expiration date 26-NOV-2016, route dose and therapy type were not reported). Concomitant drug was not reported. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Redness/flushing of face & chest, difficulty breathing, chest pain. Gave 0.3 mg EPINEPHRINE IM. 10/23/09 Hospital records and discharge summary received for DOS 9/17-9/18.  FINAL DX: Probable allergic reaction after receiving Pneumovax vaccination- now improved, chest discomfort secondary to probable allergic reaction- improved- negative serial troponin , electrocardiogram assessment, hypokalemia-replaced and corrected, hypertension- blood pressure improved, hyperlipidemia- stable on statin therapy, type II diabetes with steroid induced hyperglycemia. Flu vaccine given 9/16. Pneumovax given 9/17. A few minutes s/p Pneumovax  throat tight, red face, hot flashes, dizziness, palpitations, SOB,  and chest pain. Given cold tab and epi by pharmacy. Presented in ER improved.  Blood sugar abnormal. KCL abnormal. Cardiac WNL.  23 hr observation and tx. Discharged to home.
Tingling in throat for the first 15-20 minutes, then it stopped. Had an EpiPen just in case. Painful arm after injection. Still having pain. Had headache after injection. after 4-5 hours headache started again. Hard to keep eyes open, having a lot of pressure in head, osteroarthritis has flared, back pain is worse, arm hurts even she's not moving, having joint pain in wrist, swollen lymph nodes, and feeling very tired. Having a lot of joint pain. Everything has been harder to do today. Still having throbbing headache with pressure. Did not take any medication yesterday. Took prescription medication today after about 16 hours after vaccination.
On my daughter's left cheek I noticed dozens of pin prick size red dots scattered. Some on her left ear and under her right eye as well. They are flat, do not itch or hurt her. After immediately calling the nurse at the Pediatrician's office and explaining the reaction to her, she asked the doctor. He said it wasn't from the Hep B vaccine. Reactions from that vaccine are hives and rashes. My daughter has never experienced this before and approximately 20 minutes after receiving the vaccine she has these spots on her face.
nurses gave her an expired dose of FLUZONE QIV NP with no reported adverse event; Initial information received  on 03-Nov-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 58 years old female patient who reported nurses gave her an expired dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 03-Nov-2022, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once (lot UT7384KA; expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for Immunization.  On 03-NOV-2022 the patient reported a non-serious event nurses gave her an expired dose of INFLUENZA QUADRIVAL A-B VACCINE with no reported adverse event (expired product administered).  Action taken: not applicable.   At time of reporting, the outcome was Not Recovered / Not Resolved for the event.    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 the 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.
Approximately 8 hrs after administration of the vaccine, a period of approximately 3 days followed with fever (101-102 degrees), sore throat, mild body aches, reduced appetite.
4th dose got Moderna; throat and vocal cords were struggling; throat and vocal cords were struggling; mild sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history included: "rare bone disease" (unspecified if ongoing), notes: A rare bone disease. It is a genetic disease. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 4), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (DOSE: 3), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (DOSE: 2), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (DOSE: 1), for COVID-19 Immunization, reaction(s): "COVID-19", "Drug ineffective". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Sep2022, outcome "unknown", described as "mild sore arm"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "4th dose got Moderna"; PHARYNGEAL DISORDER (non-serious), VOCAL CORD DISORDER (non-serious), outcome "unknown" and all described as "throat and vocal cords were struggling". Additional information: Patient has never been immunocompromised, and has rarely got the flu. This is not the flu. She hasn't had a fever the whole time. She had a mild sore arm. Her throat and vocal cords were struggling. She's not in the hospital and she's not dying so she's very thankful for what Pfizer has accomplished.
Muscle pain throughout the arm lasted for 3 days. OTC pain med: ALEVE and Naproxen helped.