chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AE(s) following prior vaccinations: States any vaccines her arm is sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN6200) at the age of 74 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: takes cholesterol medication. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose:1, lot EM9810.), administration date: 04Feb2021, when the patient was 74-year-old, for Covid-19 Immunization, reaction(s): "States any vaccines her arm is sore"; Flu shot (States she had more soreness with her last flu shot.), for Immunization, reaction(s): "soreness"; Shingles (States the last one was shingles a couple of years before), for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "AE(s) following prior vaccinations: States any vaccines her arm is sore".  Additional information: Reporter stated that, the vaccination was given on Monday and yesterday her husband had a sore arm and she was in bed all day, she felt like she had the flu or something. The caller mention that that was not unusual as it happened with a couple of her friends. Agent relays the callers husband weighs #withheld and the caller is #withheld. The caller provided weights as she had a question about why the dose for the Pfizer Covid 19 vaccine was not adjusted for weight and that she addressed that. Agent relays the caller mentioned that her symptoms were much worse outcome than her husband. The caller states they are both 75 years old and in relatively good health.   No  follow-up attempts are possible. No further information is expected.    .
Patient came back to the pharmacy 2 days later reporting pain and red rash on her left arm.  Patient reports not being able to lift her arm up for 2 days and that the red area on her arm is tender to the touch.
11-22-21 Covid-19 booster shot(Moderna) - Pharmacy.Experienced servere side effects. Evening of same day chilled developed for several hours. Later in the evening I was unable to get out of the chair.. I had veritally no muscle strentgh in my arms or legs. My wife had to lift me out of the chair using the walker we had in the basement and my little strength I did have. We managed to get to the spare bedroom which had a day bed.. Fell into the day bed. I spent the night in the bed. I tried to get up a couple of times during the night without any success. The next morning I did manage to setup on the bed. Then stood up with the aid of the walker. Got to the living room and sat down in straight back chair. After about an hour , I was able to stand and walk walk without the walker. At that point I felt my sttrength was back although I had muscle aches from straing to get up early. Did not have a fever during this time. I had no more side effects the remainder of the day or since then.
Information has been received from a pharmacist concerning a 62 year old female patient with a history of fibromyalgia who on an unspecified date was vaccinated with one dose of ZOSTAVAX (Merck) (lot # and expiration date not reported). In the evening after receiving the vaccine the patient experienced chills and zoster-like symptoms. No treatment was given to the patient (also reported as the adverse events improved on therapy). A few days after the onset date, the patient recovered from chills and zoster-like symptoms. The patient did not seek medical attention. No further information is available.
Edema, redness, pain. Took 600mg IBU at 2200 on 9/12/17 with no decrease in pain or swelling.
Patient received vaccination on 12/16/2004. On 12/20/04, the patient called doctors office reporting nausea, generalized myalgia, a large local area of reaction at the injection site, also malaise and feeling very ill. Patient had to miss work and go to bed. On 12/27/04 the doctor office followed up with the patient, who reported body as a whole symptoms have gone but sill has tenderness at the injection site. The injection site local reaction was also very large and extreme with blotching, heat, redness and swelling at the time of first report of reaction. This information is per patient, patient was not examined.
I responded to a text link for VAERS reporting which generated a phone call to me.  I sought treatment for HLAB27 Anterior Uveitis and a UTI on 11.23.21. Due to vision loss and discomfort in the left eye, I received care from DO ophthalmologist.  Anterior uveitis and left closed angle glaucoma were diagnosed.  Left Iridotomy on 11.30.21. Subsequently, left iridotomy repeated and right iridotomy performed.
Few spots; red rectangle on arm around the injection site on left arm; itchy and broke out across forehead; welts; ear was beet red, redness on chest and underneath nose and over top lip; Ear hot/ as feeling like it was on fire; tingling on ear, chest, underneath nose and over top lip; itchy on her chest and underneath her nose and over her top lip; Initial information regarding an unsolicited valid non-serious case was received from a consumer or non-health care professional via Medical Information (Reference number- 00302631) and transmitted to Sanofi on 06-Oct-2020.  This case involves a 79-years-old female patient who experienced itchy and broke out across forehead (rash pruritic), welts (urticaria), ear was beet red, redness on chest and underneath nose and over top lip (erythema), ear hot/ as feeling like it was on fire (Feeling hot), tingling on ear, chest, underneath nose and over top lip (paraesthesia) and itchy on her chest and underneath her nose and over her top lip (pruritus), few spots (rash macular) and red rectangle on arm around the injection site on left arm (vaccination site erythema), after she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 05-Oct-2020 at 9:00 AM, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via an intramuscular route in the left arm for prophylactic vaccination.  On 05-Oct-2020 at 11:00 AM, the patient developed a non-serious itchy and broke out across forehead (rash pruritic), welts (urticaria) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 05-Oct-2020, the patient developed a non-serious ear was beet red, redness on chest and underneath nose and over top lip (erythema), ear hot/ as feeling like it was on fire (Feeling hot), tingling on ear, chest, underneath nose and over top lip (paraesthesia) and itchy on her chest and underneath her nose and over her top lip (pruritus) 4-5 hours following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  The patient developed a non-serious few spots (rash macular) and red rectangle on arm around the injection site on left arm (vaccination site erythema) unknown latency following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Laboratory details were not reported.   The patient was treated with CALAMINE, DIPHENHYDRAMINE HYDROCHLORIDE (IVAREST [CALAMINE;DIPHENHYDRAMINE HYDROCHLORIDE]), PARACETAMOL (TYLENOL) and used a cold compress.  The patient was recovering from rash pruritic, urticaria, erythema, burning sensation, paraesthesia, pruritus at the time of reporting.  The event outcome was unknown for rash macular, vaccination site erythema.  There will be no information available on the batch number for this case.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender The patient's concurrent and historical conditions were not reported. On 08-MAR-2016, the patient was vaccinated an improperly stored dose of (Oka/Merck) VARIVAX (Lot number L037563, expiration date (exp) 29-SEP-2016, dose, route and anatomical location were not provided. The patient's concomitant medications were not reported. The reporting nurse stated that unspecified doses in (Oka/Merck) VARIVAX immunization series were improperly stored in a temperature of -5.9C, the time frame was 15 hours and 38 minutes. There was previous temperature excursion, data was cumulative since 04-MAR-2016. The vaccine involved included (Oka/Merck) VARIVAX private stock: Lot #L035124 exp 14-SEP-2017 and (Oka/Merck) VARIVAX VFC stock: Lot #L037563 exp 29-SEP-2017. No adverse effects were reported, no product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
no other adverse effects were reported in the patient; received a dose of VAQTA that had expired; This spontaneous report has been received from a nurse regarding a 8-years-old patient of unknown gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 27-JUL-2020, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5 (units not reported), at a dose of 0.5 milliliter (route of administration not reporter; lot # S007768 has been verified to be a valid lot number for Hepatitis A Vaccine, Inactivated (VAQTA), expiration date 24-JUL-2020). No other adverse effects were reported in the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007768; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt daughter reported next day that explosive diarrhea occurred.  Recommended ER or urgent care.
Dizziness like four times a day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness like four times a day) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included PROPOFOL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (Dizziness like four times a day). On 16-Feb-2021, DIZZINESS (Dizziness like four times a day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Approximately 7 hours after vaccination, my neck began to ache. Shortly thereafter, I began feeling cold and having chills. This progressed to rigors and fevers (highest temperature measured 102.9 F), which continued through the night. The following day I felt weak. Within 48 hours, the worst of it was over, although I did have mild pain at the injection site for 2-3 days.
The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
fever, chills, ulcers to mouth, body aches;pt put on ATB-amoxil;
Mild fever (<101), chills, headache, muscle aches, extreme fatigue, inability to follow through on thoughts (brain fog), nasal congestion
Pt came into office following day with erythema, swelling, and induration at injection site. Pt had temperature of 100.3 degrees. No active treatment at time of exam. Pt adv to do cold compresses, ibuprofen as needed and watch a wait. A line was drawn around area of erythema and if goes outside area go to urgent care or ER. Or if any other symptoms occur go to ER immediately.
This spontaneous prospective pregnancy report was received from a consumer referring to her 20 year old daughter. The patient's concurrent conditions included whooping cough. On unknown date, the patient became pregnant. The last menstrual period (LMP) was approximately on 23-JUL-2015, and the estimated date of delivery (EDD) was 28-APR-2016. The pregnancy outcome was unknown. On an unspecified date, the patient visited to her obstetrician gynecologist (OB-GYN) to receive treatment for whooping cough. The reporter stated that approximately on 10-FEB-2016, the patient received a dose of GARDASIL (Lot number, expiration date, dose, route and anatomical location were not reported) instead of the treatment for whooping cough, the vaccine provider did not acknowledge the mistake until 2 weeks later when the patient revisited the office for another unspecified reason, on an unspecified date in February 2016, the patient did not feeling well. At the time of the report, the outcome of malaise was unknown. Additional information has been requested.
Arm soreness starting a few hours after vaccination and lasting for 24-36 hours; mild-moderate pain Muscle aches starting 12 hours after vaccination and resolving within 24 hours Mouth Ulcers-48 hours following the vaccine painful mouth ulcers/canker sores appeared. 14 were counted all appearing suddenly on gums , inside of lips, and tongue. Ulcers have not yet healed
This spontaneous report was received from a medical assistant regarding unknown patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown dates, the unknown patients were vaccinated with improperly stored (incorrect product storage) doses of GARDASIL 9 (lot # L043213 and expiry date 31-AUG-2017) (lot # M004116 and expiry date 31-OCT-2017) (dose, frequency and route were unknown). No concomitant medications were reported. On unspecified dates the vaccine was exposed to temperature excursions of 1 Celsius for 176 hours and 9 Celsius for 32 hours. There were no prior excursions and a data logger was not used. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of the three reports received from the same reporter. Additional information has been requested.
severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; rheumatism; sciatica; This is a spontaneous report received from a contactable consumer. This consumer reported similar events for 2 patients. This is 2nd of 2 reports. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe pain in back and right side thigh, knee and leg, diagnosed as either rheumatism or sciatica. The pain was started within one day of shot and had not stopped. The outcome of events was not recovered.  Follow-up (16Apr2021): 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 have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021085061 same reporter/ drug/ AE, different patient
Arm swelling with a size of 8x 9 cm; arm itching; A spontaneous report  was received from a Physician concerning a 84-year-old, female patient who experienced arm swelling with a size of 8x 9 cm and Itching.   The patient's medical history was not provided by the reporter. Concomitant medications reported included lisinopril and primidone.   On 11-01-2021, time not specified, eight days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left deltoid .arm for prophylaxis of COVID-19 infection.     On 19-01-2021, the patient experienced Arm swelling with a size of 8x 9 cm and Itching. The patient is still experiencing these symptoms. Treatment for the events was not provided.    Action taken with mRNA-1273 in response to the events was not reported.     The events, Arm swelling with a size of 8x 9 cm and Itching were considered not resolved.
Patient received Fluvirin/Trivalent Preservative Free given in the Right Arm 0.50ml - Novartis Vaccine- Lot # 145903 Vis date-8/19/14.  On 10/14/2014 with some neck pain before bed.  On 10/15/2014 began having worsening neck stiffness.  She is unsure if she slept on it wrong.  On 10/16/2014 had painful, rightward torticollis and unable to move to midline.  It responded to OMT with moderate increase in mobility and decrease in pain.  She was given Flexeril and steroid burst as an outpatient.
Information has been received from an office manager concerning a 20 month old female who on 19-AUG-2005 was vaccinated with Varivax (lot # 646817/1063N). In January 2006 the patient experienced chicken pox. It was unknown if medical attention was sought. Additional information has been requested.
Slight distress; This case was reported by a consumer via call center representative and described the occurrence of emotional distress in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced emotional distress. On an unknown date, the outcome of the emotional distress was recovered/resolved.   It was unknown if the reporter considered the emotional distress to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 75 years or 76 years. In 2019, the patient received Shingrix in the left arm and on next day, the patient experienced slight distress and this resolved within one day. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248574:Same reporter US-GLAXOSMITHKLINE-US2020248569:Same reporter US-GLAXOSMITHKLINE-US2020248580:Same reporter US-GLAXOSMITHKLINE-US2020248587:Same reporter
STOMACH ACHE; BURPS LIKE VOMIT; TYPICAL CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced stomach ache, burps like vomit, typical chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache, burps like vomit, typical chills, fever, and headache. This report was non-serious.
48 hrs after injection, developed unusual circular reddened non-raised area (L) arm approximately equal to 2 inch below & medial to injection site. See progress notes.
nurse reports that an MA gave16 year old Flublok instead of prescribed Fluzone Quadrivalent. No adverse event; nurse reports that an MA gave16 year old Flublok instead of prescribed Fluzone Quadrivalent. No adverse event; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a Nurse via Office Staff.  This case is linked with 2019SA267180, 2019SA267187, 2019SA267188 (same reporter)  This case involves a 16 years old female patient who was vaccinated with dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11 Sep 2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE , Frequency: once, lot QFAA1903 , exp date: 19 May 2020 intramuscularly in left arm instead of prescribed dose of INFLUENZA QUADRIVAL A-B VACCINE lot number not reported.  It was a case of actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  At the time of the report, 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 the sender: none
I woke up and I felt like I had the flu. I was very stuffy, sore throat, running nose, and coughing. I took the test on the same day and tested positive for COVID-19. I had a telehealth visit and they prescribed me Paxlovid.