chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right upper arm red, swollen, warm and painful to touch two days after Dtap immunization given.  Ice pain, reliever.
RASH AND RAISED RED AREA APPROXIMATELY 2INCHES BY 1 INCH AROUND INJECTION SITE.
Donor went to emergency dept for neurological paralytic symptoms, mostly on face.  Diagnosis of Bell's Palsy. Treated and released.
Bottom lip started swelling for about an hour.  Then it slowly started to calm down.  After 36 hours, all signs of swelling gone.
This spontaneous report was received from a registered nurse, via company representative, regarding a 16 year old female patient. The patient's medical history, concurrent conditions, drug allergies, and concomitant therapies were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 injection administered intramuscularly (strength, dose, lot number and expiration date were not reported) for the prevention of HPV (Human Papillomavirus). On an unspecified date (reported as "right after receiving GARDASIL 9"), the patient felt dizzy and fell down in the physician's office. It was unknown if laboratories were performed or treatment was given for the events. No intervention to prevent serious criteria was performed. At the time of reporting, the patient had not recovered from the events. The reporter did not provide a causality statement between the event and the suspect vaccine. Additional information has been requested.
A 20-year-old female patient developed generalized itching within 24 hours of receiving the subcutaneous injection of JE-VAX (dose one) lot number EJN222A (expiry date 13/May/2008) in the right arm on 13/Apr/2006. Per reporter vaccination was received during a travel physical and the patient had no illness at the time. The patient had no rash or hives. Per reporter the patient recovered.
p/vax pt exp h/a; flue-like sx; & fitful sleep; tx: tylenol;
Pt. filled out questionnaire and stated had not received any covid vaccines.  Pt. told RN she did not have a card and as it was her first vaccine.  When charting she was vaccinated on 3/2/21 with Moderna.  She was vaccinated today 9/21/22 with Pfizer.  No reaction at the time of todays vaccination.  She is pregnant and an inmate at the jail.  Was seen 9/14/22 by Midwife at Medical Clinic and vaccinated with TDAP and Influenza at that visit.
Vaccine given ~2:05 PM. Patient reported no problems 15 minutes post vaccine. Patient called around 3:30 PM to state he may be experiencing "itchy tongue" and "scratchy throat", which started about 15 minutes after he left the store (~30 min post vaccine).  He reported no other signs/sx at the time. He was advised to seek immediate medical attention since wife was with him, he's ~5 min from local hospital, and no other severe sx were currently present. However, he was advised to contact 911 if any severe reaction (e.g., difficulty breathing, passing out, etc.) appears. Pt said he would discuss this with his wife, and we discussed that an allergic reaction can progress quickly. He said he has benadryl on hand, but we discussed that benadryl will not be enough if patient does develop a severe allergic reaction/anaphylaxis. Patient was advised to contact his on-call Dr. for a second opinion at the very least if he does not go to the ED and to continue monitoring for additional signs/sx of allergic reaction. Patient was advised to follow up with us in a few days for update.
pt recv vax & devel an inj site rxn characterized by a 10-cm area of redness, swelling & pain;seen MD who prescribed warm compresses & APAP;
Severe pain at site of injection, sever swelling, redness and hot to touch, fever by evening with development of rash.
Healthy special operations officer developed chest pain on day 9 post small pox vaccine. Admitted to civilian hospital on 28 Nov 06. Diagnoses with post vaccinial myocarditis. 12/27/06-records received and reviewed for DOS 11/28-11/29/06 DC DX: Pericarditis, mild myopericarditis with EKG suggestive of pericarditis.  HX of present illness, developed severe reaction on the dorsum below left deltoid encompassing most of lateral left upper arm. Lymph node on right mandible and axille, tender. Two nights of night sweats. Retrosternal chest pain. Lesions on neck and face, Infectious Disease Assessment: skin reaction to small pox and myocarditis manifestations.   Follow-up received on Mar 28 2007 states - Pt recovered from the adverse events that were reported for this vaccination. No signs of myocarditis on residual cardiac involvement.
Patient received injection 12/14/04 SQ LA. 12/15/04, came to office having questionable reaction: fever, bad pain left arm, redness, swelling, flushed, headache. Patient called and admitted to hospital on 12/15/04 - 12/16/04. Diagnosed with cellulitis. Went to ER; got worse. Still in hospital.
Beginning 2 days after vaccination, minimal bilateral forearm pruritic blistering occurred. Over following 2-5 days, patient stratched blistered causing them to open and now rash appears to be resolving. No rashing on chest or face. No associated brusing, bleeding (epistasis or gingival), GI distress, fever or chills.
This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The batch number was not reported. The medical assistant called in to report that the patient experienced flu-like symptoms from SHINGRIX. The health care professional questioned that should the patient receive the 2nd dose and if there was any information on if the flu-like symptoms would subside or continue. The health care professional did not have specific patient identifiers.
got bumps; couldn't stop shaking; bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (got bumps), NERVOUSNESS (couldn't stop shaking) and VACCINATION COMPLICATION (bad reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (got bumps), NERVOUSNESS (couldn't stop shaking) and VACCINATION COMPLICATION (bad reaction). At the time of the report, SKIN MASS (got bumps), NERVOUSNESS (couldn't stop shaking) and VACCINATION COMPLICATION (bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was also not reported.   Reporter did not allow further contact
4 days after receiving Flu vac. his neurological symptom worsen, experiencing intense tingling of face, scalp, hand and feet. Symptoms decreases with prescribed Ativan.  11/2/23 Message his PMD and was prescribed Prednisone
outbreaks on both his upper legs that looked like poison ivy; area is itchy on both legs; rash is on both legs in similar spots; This spontaneous case was reported by a consumer and describes the occurrence of RASH (outbreaks on both his upper legs that looked like poison ivy), PRURITUS (area is itchy on both legs) and RASH (rash is on both legs in similar spots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced RASH (outbreaks on both his upper legs that looked like poison ivy), PRURITUS (area is itchy on both legs) and RASH (rash is on both legs in similar spots). At the time of the report, RASH (outbreaks on both his upper legs that looked like poison ivy), PRURITUS (area is itchy on both legs) and RASH (rash is on both legs in similar spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
About seven hours after vaccination (~5:30pm), felt slight chills. Over about a half hour, they escalated to severe chills and a 101.9 degree fever that lasted through the night. Chills subsided about 3am, but fever remained until following morning and slowly lowered until about noon the  day after vaccination. That day, arm soreness increased, with sharp pain when arms raised or pressure applied, and soreness continued until  five days after vaccination.
Very sore arm with moderate pain and a patch of redness, measuring four inches long by about three inches wide (no swelling) about two inches lower than the injection site.  Experienced extreme tiredness and lethargy after the injection (lasting about two days), overall muscle pain, headache, shivering, fever, mild lightheadedness, and nausea.  These side effects were so pronounced that they prevented me from doing regular activities until two days after.  After two days, the symptoms were still there, especially the soreness on the arm where the injection was given, but I'm at least up-and-about two days later and am back to a regular routine--albeit, more slowly than normal.
This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On 12-FEB-2019, the patient was vaccinated with M-M-R II subcutaneous, lot # R002930 and expiration date 31-JAN-2019 (dosage schedule, anatomical location were not reported). On the same day, the patient received a first dose of M-M-R II, however the dose das expired on 30-JAN-2019 (expired product administered). The outcome of expired product administered was unknown.
Medical assistant reported that an employee accidentally gave FLUBLOK to a 16-year-old with no AE; Initial information received on 09-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 16 years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age).  Relevant medical history, medical treatment, vaccination, concomitant medications and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA).  On 06-Nov-2020, the patient received a 0.5 ml (Lot number- UT7035LA, Expiration date- 30-Jun-2021) dose of suspect via intramuscular route in the left deltoid for prophylactic vaccination (Product administered to patient of inappropriate age).  It was a case of an actual medication error due to inappropriate age at vaccine administration.  No relevant laboratory data 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.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 20-APR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified date, the GARDASIL vaccine had a temperature excursion of 1172 hours. The lowest recorded temperature was -3 (-3 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
pruritic eruption beginning 1-2 days post inject; some lip swelling; much induration @ inject site; needed DPH, Seldane;
Eczema; rash/ Full body rash; This is a spontaneous report from a contactable consumer (patient's son). A 95-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in arm right on 06Mar2021 (at the age of 95-years-old) as single dose for COVID-19 immunisation. The patient's did not had any medical history including any illness at time of vaccination. The patient's concomitant medications were not reported. It was unknown whether the patient had history of any previous immunization with the Pfizer vaccine that would be considered as suspect. The patient did not administer any additional vaccines on same date of the Pfizer suspect. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE on 11Feb2021 (at the age of 95-years-old) for COVID-19 immunisation. The patient did not receive any prior vaccinations within 4 weeks. The consumer reported that post 2nd dose vaccination, the patient developed a rash that has been ongoing for 12-14 weeks now. The rash initially appeared on his torso and his entire body (full body rash). Currently, some of which has subsided in some areas but the rash was still evident all over his body. The patient went to his primary care doctor and also a skin doctor and they tried to sort out what it could be. The patient's physicians tried multiple treatment regimens to treat that but to no success. The consumer reported that it seems to coincide with the shot. The patient has had no medication changes. The consumer was not necessarily looking to report the side effects at that point as he didn't know if the vaccine was the cause, but they have not been able to explain it. The consumer was unsure of exact date of the event. However, he thought it was 12Mar2021. The consumer further stated that it was either the end of March or the middle of March. He attempted to confirm the rash broke out on rash on a Saturday with his father. The patient underwent biopsy a couple of weeks ago (May2021), the rash was tested and he thought it came back as eczema. The patient went to urgent care first and followed up a week later with his primary care doctor regarding the rash. The events required a visit to emergency room and physician office. There was no family medical history that pertained to the rash. The consumer would like to know if that has been reported side effect in relation to the administration of the vaccine and would like to seek treatment recommendation or remedy in line with the event. The outcome of all the events was not resolved.  Information on Lot/Batch number has been requested.
peculiar taste; heavy arms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (peculiar taste) and PAIN IN EXTREMITY (heavy arms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced TASTE DISORDER (peculiar taste) and PAIN IN EXTREMITY (heavy arms). At the time of the report, TASTE DISORDER (peculiar taste) and PAIN IN EXTREMITY (heavy arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact.
non consolable high pitched cry w/clenched fists from 6PM until 12 MN 25NOV92; APAP had been given as instructed; temp was 100 ax;
A couple hours after receiving vaccine the arm I got the shot in began hurting severely. The following day the pain was even worse to the point I couldn't use my arm. This persisted for a month until I went to see Dr. Dr. performed light and pulse treatments. Symptoms began improving after the first treatment and resolved after a week of treatments.
1) In the late afternoon on vaccination day has a very small fever and felt extremely tired. This continued for 3 days and resolved naturally. Did not take any medications. 2) On May 5 early in the morning noticed a redness at the injection site, slightly larger than the size of a quarter coin. No itch. Later in the day started to feel very tired again, although not as bad as on the days following the injection. On May 6 the redness on the arm doubled in size, redder around the edges and whiter in the middle. On May 7 in the late evening noticed that my left supraclavicular lymph node became swollen. The area felt tender and painful to touch. This continued for 84 hours and then resolved. No medication taken.
3 days after the injection I experienced a heavy chest and shortness of breathe on exertion. This happened after receiving each shot.
Acute right posterior cerebral artery stroke, symptoms (headache, vision change) started 06/26/2021, patient sought medical attention and diagnosed 06/28/2021
fever 102 degrees, fatigue lasting several weeks, weakness lasting several weeks, pain at injection site
None (patient received 2nd Influenza vaccination at our pharmacy without informing the staff of her prior vaccination).
No adverse effects; A patient received 1 dose of PNEUMOVAX 23 on Friday 8/30/2019; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 30-AUG-2019, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis, lot number S004548 with expiration date in 12-AUG-2020 (strength and anatomical location not reported).  The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 47 Fahrenheit (°F) (51 F) for the time frame of 7 hours. There was no previous temperature excursion and the call was because of a data logger.   No adverse effects reported.
Cold symptoms returned and then I tested positive again after 2 negative tests at days 7 & 9.; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: Name of Drug as Reported: No, Reaction: Allergy, . The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Dec2022, outcome "unknown", described as "Cold symptoms returned and then I tested positive again after 2 negative tests at days 7 & 9."; COVID-19 (medically significant) with onset Dec2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I tested positive again after 2 negative tests at days 7 & 9; Negative, notes: I tested positive again after 2 negative tests at days 7 & 9; Negative, notes: I tested positive again after 2 negative tests at days 7 & 9. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: the patient not taking any other medications/products within 2 weeks of starting COVID-19 treatment. patient previously receive a COVID-19 Vaccine. Other medication in 2weeks: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 days after getting the FLUZONE high-dose flu shot I began feeling nauseous, followed by diarrhea and the chills. I continue to still have these symptoms 5 days after injection.
Pt to clinic in am for MMR and Varicella vaccine.  Vaccines administered by RNs.  Pt had temperature 103.7 rectally that evening.  No s/s of lethargy or irritabilty, pt still acting normal per parents.  Pt given Tylenol, temperature decreased to 102.  The next morning temperature 100.4 rectally without Tylenol.  Pt acting normal.
no AE; expired dose of VARIVAX administered; This spontaneous report was received from an office manager and refers to a patient of unknown age. The patient's medical history was not reported.  On 16-NOV-2021, the patient was vaccinated with and expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S033539, expiration date 22-OCT-2021, 0.5 milliliter, subcutaneously for prophylaxis.  No additional adverse event was reported.
Irregular periods since vaccine: First dose - 04/06/2021 - period 10 days late Second dose - 05/05/2021 - period 10 days early 9 days into birth control pack (21 day pack - 07/04/2021) irregular bleeding started Went to GYN and they advised to stop taking pill to hopefully get cycle back on track.  THIS HAS NEVER HAPPENED TO ME WHILE ON BIRTH CONTROL FOR 10+ YEARS. BE CAREFUL. THESE VACCINES ARE NOT SAFE FOR WOMEN.
Information has been received from a physician concerning a 58 year old healthy adult female with allergies who on 4/30/03 was vaccinated with a first dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. Subsequently the pt developed a high fever of 103 and pneumonia. The physician indicated that the pt was sick for 3 to 5 days. No other information is available. Unspecified medical attention was sought. There was no product quality complaint. Follow up info from a physician indicated that the pt was seen in the local emergency room and was treated with antibiotics and steroids. It was noted that the pt has recovered. The physician also indicated that the pt does have allergies, "but they would have nothing to do with the vaccination." Upon internal review, a high fever of 103 and pneumonia were considered to be other important medical events (OMIC). Additional info has been requested.  Follow up on 07/17/2003: "Follow up information from a physician indicate that the patient was seen in the local emergency room and was treated with antibiotics and steroids (unspecified).  It was note that the patient was recovered.  The physician also indicated that the patient does have allergies, "bt they would have nothing to do with the vaccination".  On 06/17/2003, it was reported that "no additional information is available at this time."  Upon internal review, a high fever of 103 and pneumonia were considered to be other important medical events (OMIC)." A 15-day follow up report received 9/5/2003 adds: Follow up info on 08/25/2003 indicated that the physician has "not heard from the pt any more". No further info is expected.
Client reports constricting feeling in chest, cough becoming productive, difficulty breathing and those symptoms lasted through PM. Client went to bed. Awoke next morning with face/eyes swollen - these symptoms lasted through next day. Entire event lasted approximately 24 hours. Client did not seek any treatment.