chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he got the flu; Initial information regarding an unsolicited valid non-serious case received from a non-healthcare professional (patient's relative) via social media on 03-Dec-2020.  This case involves a male patient of unknown age who got the flu (Influenza), while the patient received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s) and family history were not provided. Patient had Flu shot in past and had Flu.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter stated that his/her brother got the flu shot 5 years in a row and 4 of those 5 years he got the flu (Influenza), he finally got the hint and did not get the shot.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information about the batch number in this case.
tenderness under the skin of his mid to lower back; pain is spreading to the front of his body; This case was reported by a consumer via call center representative and described the occurrence of skin tenderness in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th April 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2022, 3 days after receiving Shingrix, the patient experienced skin tenderness and radiating pain. On an unknown date, the outcome of the skin tenderness and radiating pain were not recovered/not resolved.   It was unknown if the reporter considered the skin tenderness and radiating pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's comment: The patient received Shingrix in an unknown deltoid. Approximately 3 days later patient began to experience a tenderness under the skin of his mid to lower back.   He stated this pain was spreading to the front of his body.  The pain was unresolved.  No Lot number or Expiration date was known for the vaccine. The reporter gave permission to contact Health care professional.
PT HAD SYNCOPE ~10 MIN AFTER VACCINATION.  TEMPORARY LOSS OF CONSCIOUSNESS, TONIC-CLONIC ARM MOVEMENTS FOR ~5-10 SECONDS.  PT REGAINED CONSCIOUSNESS ABOUT 30-60 SECONDS AFTER ONSET.
Body rash, redness, itching , and peeling  Treatment- Steroid creams, Allergy medications, -Outcome to be determined
Patient received vaccines 3-21-07 at around 11:30 AM later that day around 6:00PM she started to present shaking of upper and lower extremities: eyes were rolled up lasting approx 5 seconds.  5/22/07 Received hospital medical records which reveal patient experienced fever, possible seizures, suspected sepsis & poor feeding.  Parent reported repeated seizure like activity w/starring, shaking of extremities at home for approx 5 sec.  Admitted 3/21-3/24/07.  Neuro consult done. FINAL DX: possible first seizure.
worst case of Hives; Itching all over; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899, Expiry Date: 31Mar2021), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. Medical history included blood pressure abnormal, thyroid disorder.  Concomitant medication included atenolol for blood pressure, hydrochlorothiazide for blood pressure, levothyroxine for thyroid problems.On 09Jan2021, the patient broke out and got the worst case of hives to the Covid 19 vaccination, she was just itching all over and all over. The patient took diphenhydramine hydrochloride (BENADRYL) and everything and nothing was helping. The outcome of events was unknown.
Began falling down for unknown reasons. Fell twice that day and this continued through Nonember 2008. Hospitalized on December 1, 2008. Administered IVIGs.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unspecified date in July 2010, the patient was vaccinated with the first dose of RECOMBIVAX HB and on 16-OCT-2013 was vaccinated with the second dose of RECOMBIVAX HB (doses, route, lot # were not reported). The patient was in the office to receive the third dose of RECOMBIVAX HB on 11-DEC-2013. No adverse event reported. Additional information is not expected.
Administered shot, patient turned pale after about 5 to 10 minutes Began to exhibit problems breathing after abtou 15 more minutes- gave 1 epi-pen a 3mg shot. Patient responded within a few minutes with more relaxed feeling and decreased throat problems.
joint pain; Headache; This is a spontaneous report from a contactable consumer (patient). This 52-year-old female consumer reported in response to Non-HCP follow up letter sent in cross reference case which included that:  A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0186; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 03Jun2021 16:43 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included hypersensitivity, anaemia and oral herpes from an unknown date and unknown if ongoing. Concomitant medications included levocetirizine (LEVOCETIRIZINE) taken for hypersensitivity from 25May2021 to 01Jun2021; famciclovir (FAMCICLOVIR) taken for oral herpes from 11Jun2021 to an unspecified stop date and ferrous gluconate (POLY-IRON [FERROUS GLUCONATE]) from 2021 to an unspecified date [Been taking this or a long time- on and off. I was taking the iron pill days before the 03Jun2021 1st dose] for anaemia. On 03Jun2021 patient experienced joint pain and headache. The outcome of both the events was unknown.  Follow-up attempts are completed. No further information is expected.
got shot at noon. by 10pm right eye was swollen itchy and foggy. had a severe headache and congestion
a rash on the front my right leg below the knee appeared . It was non responsive to  topical OTC hydrocortisone.  It has lasted for 3 weeks and is still not going away.
tingling on left side of the body/tingling on my left side of the body near my arm and shoulder where the injection was given/tingling in my face, glutes and back; burning and tingling in her hands and feet; burning and tingling in her hands and feet; burning and tingling in her hands and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101267984 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 15Apr2021, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "tingling on left side of the body/tingling on my left side of the body near my arm and shoulder where the injection was given/tingling in my face, glutes and back"; BURNING SENSATION (non-serious), BURNING SENSATION (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "burning and tingling in her hands and feet". The events "tingling on left side of the body/tingling on my left side of the body near my arm and shoulder where the injection was given/tingling in my face, glutes and back", "burning and tingling in her hands and feet", "burning and tingling in her hands and feet" and "burning and tingling in her hands and feet" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: PQC was present. Patient presented AE after her 2nd shoot of Pfizer COVID 19 vaccine. Tingling on left side of the body, 2-3 days later it disappeared, 4 months after the 2nd shot she noticed tingling in feet, legs, arms and hands. Report was not related to a study or programme. NDC number of Covid-19 Vaccine was not provided. Expiry date of Covid-19 Vaccine was not provided. She was getting her symptoms evaluated by a neurologist. Patient was consulting a neurologist for a thorough evaluation of symptoms. Caller said that some of the tests that her neurologists has run have all come out normal. Other Products was not provided. Investigation assessment was not provided.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
The night of vaccines, ran fever. 102 next day started getting red and very hot. By Friday evening 2 days after vaccines arm was swollen from shoulder to elbow and bright red hot. ER on 11/1 & 2-cellulitis bacterial family doctor 11/5/03. My arm was so swollen and red you could have fried a egg on it. I felt horrible. I thought it was the combination of both the flu and pneumonia vaccine at the same time in the same arm. It was not. Went to ER on 11/1/03-severe cellulitis bacterial. Poor administration and contamination by the LVN who administered vaccines. Had to have antibiotic injections and put on Keflex 500mg 4 x daily for 14 days and had to return to ER on 11/2/03 and my own personal physician on 11/5/03. Still not resolved. Still seeing my own physician. This is 11/11/03. My arm is still red and swollen, of course, better than it was. The medical record received on 2/17/04 states pain. Follow up 02/14/05: Arm is still red, like a rash, but  doing fine except for that. I don't think it had anything to do with the vaccinations. There was contamination during the administration of the vaccine,  I developed cellulitis. Medical record states lethergy. msv
Patient showed up to pharmacy to receive booster dose. Patient was a Janssen recipient (March 2021). Moderna vaccine administered at 0.5mL dose, instead of 0.25mL dose. Monitored patient; no reported adverse events. MD notified and aware of the error in dose.
Could barely walk; All her joints hurt; Felt pain in ever joint; So much pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could barely walk), ARTHRALGIA (All her joints hurt), ARTHRALGIA (Felt pain in ever joint) and PAIN (So much pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced GAIT DISTURBANCE (Could barely walk), ARTHRALGIA (All her joints hurt), ARTHRALGIA (Felt pain in ever joint) and PAIN (So much pain). On 05-Apr-2021, GAIT DISTURBANCE (Could barely walk) had resolved. At the time of the report, ARTHRALGIA (All her joints hurt), ARTHRALGIA (Felt pain in ever joint) and PAIN (So much pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
She has had a constellation of symptoms (now to date about 1 year of duration), with onset to a milder extent since prior to her COVID 19 in October 2021.    The persistent, and most concerning symptoms: fatigue, non refreshing sleep and prolonged periods of sleeping, memory loss, dyspnea, always feeling as if she has a "cold" ( nasal and chest congestion), pains in her hands attributed to her arthritis   Other concerning symptoms that are described as intermittent: subjective fever (has not recorded temperature), chills, sore throat, diarrhea, dizziness (imbalance; head doesn't  "feel right"), finger tingling.   She had COVID 19 in Oct 2021 treated with casirivimab/imdevimab (did not require hospitalization), citing feeling very ill initially. Shortly after the infusion, her symptoms markedly improved, citing resolution of hand pains though since this initial improvement the above symptoms had returned and never fully resolved.   3/11/22, she had her first PFIZER COVID 19 vaccine, and ever since then all the above symptoms have returned in a substantial, severe fashion. In addition, since the vaccination, she has had chest pain at a particular spot on her right chest worse with breathing and relieved by lying flat; her left arm over the muscle hurts. 4/7/22, she has had new abdominal pain as well.  Headaches have become prominent.
This spontaneous report as received from a medical assistant refers to a 4 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2018, the patient was vaccinated with PROQUAD (lot number M031565; expiry date: 24-DEC-2017) for prophylaxis (expired product administered). The sterile diluent which was used for reconstitution of the vaccine was properly stored. No adverse effects were reported. The reporter confirmed that the expired PROQUAD had no temperature excursions prior to being administered. Product quality complaint (PQC) was not involved.
A report has been received from a Health Professional concerning a 3 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 25-NOV-2014. It was reported that multiple patients received FLUMIST Quadrivalent and tested positive for flu A which started on 01-DEC-2014. The outcome of the event of multiple patients received FLUMIST Quadrivalent and tested positive for Flu A is unknown. The report was considered to be non-serious.
pt recvd vax; devel warm, "large apple-sized" area of induration & erythema at inject site p/ vax;pt tx w/ Ancef 2 g in rt arm & elocor cream topically,followed by didoxacillin for 1 wk;
Patient received an Adult dose of Moderna Lot #017B22A should have received Moderna 6 months to 5years old dose.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received in March 2018, refer case US2018GSK133042). On 18th July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, dizziness, vomiting, diarrhea, fever, chills, headache and general body pain. On 18th July 2018, the patient experienced pain in arm. Rechallenge with SHINGRIX was positive. On 22nd July 2018, the outcome of the pain in arm, erythema of extremities, dizziness, vomiting, diarrhea, fever, chills, headache and general body pain were recovered/resolved. The reporter considered the pain in arm, erythema of extremities, dizziness, vomiting, diarrhea, fever, chills, headache and general body pain to be almost certainly related to SHINGRIX. Additional details reported as follows: The patient received SHINGRIX on right deltoid. The patient stated that immediately after vaccination her arm soreness was not as severe as the first SHINGRIX vaccination because of better administration. In July 2018, 12 hours after receiving SHINGRIX, the patient experienced dizziness, vomiting, diarrhea, fever, chills, headache and general body pain. The patient stated that she called previously to report her experience regarding the 1st dose anonymously.
no adverse event; Patient given a dose of RECOMBIVAX HB during a temperature excursion; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 16-NOV-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # S005809 expiring on 02-NOV-2021, for prophylaxis (exact dose, frequency, route and site of administration were not reported). No adverse reactions were reported.  The hepatitis b vaccine (recombinant)(RECOMBIVAX HB) was stored at a too low temperature of 3.0 degrees Fahrenheit (F) for the time frame of 3 hours and 30 minutes.The improper storage was recorded by Digital Data Logger. It was unknown if there was any previous temperature excursion. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: S005809; expirationdate: 02-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
runny nose; cough; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of   in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-2 test: positve.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-002963, MOD-2021-003321 (Patient Link).   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
No adverse event was report by the patient. Due to refrigerator temperature excursion occurred on 8/12/16, manufacture determined base on drop on temperature that vaccine is not viable and CDC recommend revacccine.
expired dose of Menactra was inadvertently administered/no AE; Initial information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an 11 years old male patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that expired dose of Menactra was inadvertently administered/no AE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL).  On 13-Aug-2019, the patient received 1st dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5916AA and expiry date: 27-Jun-2019 via intramuscular route in the left deltoid.  It was a case of actual medication error due to expired vaccine used.  No adverse event was 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.  List of documents held by sender: none.
My left elbow exp inflammation that I'm still exp today.  On March 20 started having  irritation of my disc caused by my inflammation caused by the vaccine.I  had a vasectomy of  lower back L4, L5 on June 29. I'm only 3 weeks post surgery for my back still having concerns.
Information ha been received from a health professional concerning an approximately 16 month old female patient who on 20OCT2003 was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Subsequently, she experienced a rash, Unspecified medical attention was sought. Additional information is not expected.
Patient came in pharmacy on 11-2-18 to show me her upper left arm which was pink, warm to touch, swelling only on top upper arm, and mild pain. She received her shot on 11-19-18 but did not feel symptoms until 11-23-18. She asked me if these symptoms were related to her vaccine injection. I recommend.
No adverse effect reported; Expired dose of M-M-R II given today; This spontaneous information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On 04-NOV-2019, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human Albumin (rhA)(M-M-R II) as prophylaxis (lot number: N024703 expiration date: 08-AUG-2019) (strength, route of administration and anatomical location were not reported). The nurse did not know if the patient should be revaccinated. She was also not aware if the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) underwent a temperature excursion. The stability of the dose could not be evaluated.  No adverse effect reported.
Patient became dizzy, red-faced, breathing hard, said he didn?t feel well, a few minutes after vaccination. He was in his motorized chair and complained of lower back pain (his wife said it was an on-going problem). He was not experiencing any GI distress and his pulse was strong.  EMS was called. They evaluated the patient. He felt better and declined going to the hospital. He said he would follow-up with his PCP.
caller received 1st dose of the Moderna vaccine on 10May2021, but had to travel to another country and couldn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (caller received 1st dose of the Moderna vaccine on 10May2021, but had to travel to another country and couldn't receive the 2nd dose) 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 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (caller received 1st dose of the Moderna vaccine on 10May2021, but had to travel to another country and couldn't receive the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (caller received 1st dose of the Moderna vaccine on 10May2021, but had to travel to another country and couldn't receive the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported by the reporter.  Treatment medication for these events were not reported by the reporter.
Pt. had allergic reaction to Tetanus, developed rash felt warm c/o SOB & stomach ache. Gave pt. BENADRYL 50 mg IM ( R ) delt. per orders PA. Pt. responded well & was released from Clinic.