chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 3-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7SJ25, expiry date 31st May 2018). On 25th October 2017, the patient received FLULAVAL QUADRIVALENT .5 ml. In October 2017, less than a week after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site induration. On 25th October 2017, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site tenderness. On 27th October 2017, the patient experienced injection site discoloration. The patient was treated with Cephalexin, diphenhydramine and Hydrocortisone Cream. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site tenderness and injection site induration were recovering/resolving and the outcome of the injection site discoloration was unknown. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site tenderness to be almost certainly related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the injection site induration and injection site discoloration to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: No concomitant medications or vaccines reported. At 12 pm, the patient received FLULAVEL QUADRIVALENT on the right thigh. In the evening after vaccination, the symptoms were developed and the patient was seen in the office on the following day. A 10 centimeters area on the right thigh was noted to be erythematous, swollen and questionably tender. The patient was prescribed oral cephalexin and diphenhydramine and topical hydrocortisone cream. On 27th October 2017, the patient went for follow up visit and revealed a persistent 10 centimetre erythematous area with induration improved and a purple horseshoe area in the middle of the involved area. Continuation of all prescribed medications was recommended. No further visits were reported.
after secod vaccine, it sent me in to severe hypothroid. I have been regulated and had a thryoid test 14 Jan 2021 where my thryoid stimulating hormone was 1.703 and when I had my next test on 23 April 2021, it was at 20.921. Also got tested 23 April for EBV and that had been reactivated.  The entire month of February I had no energy and spent most of the month in bed. I had better days in March and into April.  Dr is now treating me with more Armour Thyroid and an antiviral.
pt recvd vax; pain, redness, swelling at site 4cm; possible cellulitis; blood culture neg;
Widespread itchy rash over entire abdomen, both arms and partially on thighs. Occurred on 4/5/21 and spread rapidly. Saw Dr. on 4/7 when he prescribed a 6 day course of 10mg Prednisone. after 2 doses of treatment the rash is extremely present in all location. Skin redness and itching is slightly less. Rash is still very red and darker.
Patient reported onset of nasal congestion, sore throat, and cough intermittently since vaccination.  Also reported incidence of muscle weakness "couldn't stand up" x 1 day (11/18/2021 - vaccine on 9/15/2021). Was seen in walk in with no focal deficit or treatment, self resolved. No weakness since.  Symptoms also coincide with Fall and starting of woodstove for heat.
developed hives near injection sites of MMR & VZV (each vaccine placed on different thighs) within 5 minutes of administration. Gave diphenhydramine and improved.
ASYMPTOMATIC COVID-19; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported) dose was not reported, administered on 30-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 31-AUG-2021, the patient experienced asymptomatic covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was non-serious.
Information has been received from a physician concerning an 8 week old patient who on 22-JUL-2009 was vaccinated with a dose of PNEUMOVAX 23. No symptoms were reported. Follow up information was received from the physician's office. It was reported that the patient was suppose to receive PREVNAR, but accidentally received PNEUMOVAX 23. Additional information has been requested.
Swelling in the left thigh. No pain, no fever. Benadryl given orally.
Right arm where client received vaccine reportedly became red, itchy, swollen, and stiff the third day after vaccination.  Client reported her arms was fine for the first two days then the symptoms began the morning of the third day.  Also reported a bruise at the injection site.  Denied other symptoms- nausea/vomiting, rash, headache, fever, problems breathing.  Unable to contact patient for follow-up to see if she receovered or needed any specific treatment.
Pediarix Expired dose administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11-MAY-2023) for prophylaxis.   On 01-JUN-2023, the patient received Pediarix. On 01-JUN-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Pediarix Expired dose administration). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JUN-2023 The reporter was a clinic manager. The reporter asked for information about the administration of an expired Pediarix dose to patient. The reporter asked how to proceed with this patient.  The reporter consented to follow up. The patient received an expired dose of Pediarix, which led to expired vaccine used.
Swelling & redness around site of injection- left thigh, Currently treating with warm compresses.
Patient became nauseous 15 minutes after receiving vaccine,then vomited,then fainted. We lowered him to floor with legs raised. He regained consciousness  after a few seconds,but was still  not clear-headed. He was very anxious and shaking and pale. 911 was called . He was taken to ER.,but was clear headed,with heartrate slightly elevated.
Child with sibling at well visit and should have received flu vaccine only. Child was mistakenly given the DTAP/IPV (Quadracel) during the visit (was intended for 4 y/o sibling) Nurse administered Quadracel first and mom went to lift child off table and nurse still had flu vaccine to give, which was administered.
pt recv vax 27NOV95 & 6MAY96 pt devel a classic chickenpox rash w/ a deep cough, congestion, & fever;pt was seen by MD & recovered;
Information has been received from a licensed practical nurse (L.P.N.) concerning a 94 year old female who on 16-JUL-2008 was vaccinated with a dose of PNEUMOVAX 23 (lot # 658673/0990U). On 16-JUL-2008 the patient experienced injection-site soreness and swelling and was hospitalized. On an unspecified date, the patient recovered from injection-site soreness and swelling. No product quality complaint was involved. The physician requested that a lot check should be performed. Injection-site soreness and swelling were considered to be disabling. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center and was released. Additional information has been requested.
Red, itchy patch of skin at vaccination site, which appeared  about a week after I got the vaccination. It lasted for ~8 days and faded away.  I had no special treatment.
Extreme fatigue/weakness day  1 following injection. On day 10 following injection, chest pain/palpitations, nausea/dizziness, dysrhythmias.
having a problem since I got the vaccine with keeping my balance; I kept loosing my balance; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having a problem since I got the vaccine with keeping my balance; I kept loosing my balance. The patient had a problem since got the vaccine with keeping patient balance. It was reported that patient received second dose on 02Mar2021. The outcome of event was not recovered.  Information on the lot/batch number has been requested.
2/12/22-5am-noon all tastes became bitter - only drank water didn?t eat 4am-10am 2/12/22: hot/cold flashes- ibuprofen per package instruction 4am-8:30 pm 2/12/22: fatigue, whole body felt heavy, ibuprofen otc per package & rest 4am-8:30 pm 2/12/22: slower cognition/thought processes, at times felt like eyes were having nystagmus, treated with decreased quick movements and rest 4:30-10:00am 2/12/22: increased mucus production
Preterm labor: contractions every 3-4 min for approx 1 hour requiring hospitalization and treatment.
SHIVERS; FEVER; HEADACHE IN NIGHT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 shivers, fever, and headache in night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shivers, fever, and headache in night. This report was non-serious.
Information has been received from a physician concerning her daughter who was vaccinated with  dose of varicella virus vaccine live. Subsequently, the pt developed  a chickenpox rash with less than 50 lesions. It was noted that everyone in the Pt's daycare class also developed a chickenpox rash. It was reported that the pt's present status is "fine" . Unspecified medical attention was sought. No product quality complaint was involved. The pt's sister experienced a chickenpox rash with over 200 lesions following vaccination with varicella virus vaccine live. (WAES 0503USA00222). Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 2nd dose of SHINGRIX 50 µg. On 18th October 2018, less than a day after receiving SHINGRIX, the patient experienced fever, pain and poor quality sleep. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the pain was not recovered/not resolved and the outcome of the poor quality sleep was unknown. It was unknown if the reporter considered the fever, pain and poor quality sleep to be related to SHINGRIX. Additional information was reported as follows: The patient experienced fever and body aches overnight vaccination day. The patient inquired how long the adverse effects would last. The patient receive a call back several hours later, after he inquired. On the day of reporting, the patient stated that he had 101 degree F temperature at 8 AM, but his fever was back to normal at the time of reporting. However the patient thought that the fever might go back up again at night when he sleeps. The patient stated that he felt okay at the time of reporting, just had aches fever and pains because he didn't sleep well last night. The contact details of the physician was provided.
After they had been punctured more than 12 hours prior to administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (After they had been punctured more than 12 hours prior to administration) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 014C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (After they had been punctured more than 12 hours prior to administration). On 23-Dec-2021, EXPIRED PRODUCT ADMINISTERED (After they had been punctured more than 12 hours prior to administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided.
Patient described flu-like symptoms starting the day following injection including low-grade fever and chills. Patient self-treated with OTC analgesics.
receiving the Yf-Vax via intramuscular and not the subcutaneous as the label instructs,with no reported adverse event; Initial information was received on 07-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received the yellow fever vaccine [Yf-Vax] via intramuscular and not the subcutaneous as the label instructs,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a suspect yellow fever vaccine solution for injection at a dose of 0.5 ml once lot number not reported via intramuscular route in unknown administration site (expiry date and strength: unknown) for immunization.  On an unknown date the patient received the yellow fever vaccine via intramuscular and not the subcutaneous as the label instructs,with no reported adverse event (incorrect route of product administration) (unknown latency) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown 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.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. The reporter stated that on 19-NOV-2014 the patient was vaccinated with both (Merck) VARIVAX, 0.5 ml, subcutaneously, (strength, anatomical location, lot number and expiration date were not reported), and (Merck) PROQUAD 0.5 ml, subcutaneously, (strength, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. No further information was provided. Additional information has been requested.
The miscarriage started on 12/17/2021 I had a small amount of light pink discharge by evening it was heavy like a period. The next day I was bleeding like a light period I passed two small clots and more bleeding with activity. The next day I was still bleeding and experienced diarrhea and nausea. Tuesday the 21st there was very light spotting and by the next day my pregnancy test was reading negative. The following week I had a doctors appt and it was confirmed the miscarriage was complete. I was having diarrhea the entire two weeks off and on. On 12/17/2021 prior to the miscarriage, I had a check in with my endocrinologist because I had gestational diabetes before with my pregnancies so he ran some tests and everything came back normal. I had a positive pregnancy test on 2/19/2022 and started miscarrying on 03/23/2022. The miscarriage lasted from 3/23/2022 to 4/1/2022. I felt sicker with that one and had to spend a few days in bed. I did have an appointment with my doctor during my miscarriage and he noted that he could see tissue but not enough for me to be nine weeks so it was concluded that the pregnancy stopped developing early on.
Several hours after receiving  the COVID vaccination I began to experience severe generalized  body aches,  fever 103.5, Pulse 126, Oxygen 94,
Started with swelling and redness at H1N1 site then rash spreaded down that arm and to torso. Pt complained of itching also felt like an allergic reaction she had before. Pt took allergy meds at home to help. Pt got better next day with her meds at home. Did advise pt to go to ER if symptoms worsened.
fever; very achy; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (very achy) and FATIGUE (fatigued) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A, 039K20A and 026D21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Osteoporosis (broken bones in her foot for osteoporosis).   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (fever), MYALGIA (very achy) and FATIGUE (fatigued). On 05-Feb-2021, PYREXIA (fever), MYALGIA (very achy) and FATIGUE (fatigued) had resolved.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-364321 (Patient Link).
COVID-19 or flu-like symptoms following COVID-19 vaccination/COVID-19 results were to be positive; COVID-19 or flu-like symptoms following COVID-19 vaccination/COVID-19 results were to be positive; COVID-19 or flu-like symptoms following COVID-19 vaccination; This is a spontaneous report from a contactable Other-HCP. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On unspecified date, COVID-19 or flu-like symptoms following COVID-19 vaccination was reported for the patient. COVID-19 results were to be positive on unspecified date. Changing diet to vegan was reported. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient developed localized injection site induration, itching, and pain initially after vaccine that subsided after 2 days. On day  8, local injection site reaction returned again more severe with well demarcated redness, tenderness, and itching. No systemic allergy symptoms such as wheezing, urticaria, or facial/airway swelling.
38 year old female observed  post 1st  COVID vaccine @ 1:18PM. 5 minutes post vaccine patient reported tinnitus, itchy throat, dizziness and neck/face flush. On exam lungs clear, BP and O2 stable, HR 102 BPM. Patient was administered Benadryl PO and observed. 10 minutes post benadryl patient became tachycardic and reported chest tightness and shortness of breath, patient was then administered EPIPEN to Left outer thigh. EMS activated and patient was sent to ER
Redness, induration , warm to touch left deltoid at injection site beginning evening of receiving vaccine. Prescription for Omnicef given. Resolved by 11/9/04.
Temperature Excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
About 1 hour, post vax, pt complained of difficult and painful respirations. Went in a office MD after shot. Seen doctor on 6/10/99 and dx'd as a reaction to vaccine. Just advised pr MD of this on 4/26/00.
Erythema and induration (13x7 cm), pruritis and tenderness at injection site along with increased fatigue, beginning 1 week following vaccination. There had been a local injection site reaction as well as fatigue and headache starting 24  hours after vaccine administration, which had resolved entirely within 72 hours.  New onset of injection site reaction began with pruritis only, starting in the morning 7 days after the vaccination, which progressed to include fatigue, erythema and induration during that day and into the next (today, the day of reporting). Oral certrizine was taken the evening that symptom recrudescence began, with some relief of pruritis but not erythema or induration.
Five days after. My second Moderna vaccine, my period came weeks early and was heavier than usual. Then I had another period about one week later. Now I am having cramping and spotting/irregular bleeding.
I had a pink smear in the shape of 2 connected ovals that extended down below the injection site to my elbow.  It was pink like Pepto Bismol pink.  It was like a pink suntan = not a rough rash.  It didn't hurt. I had it for about 5 days getting lighter until it is gone now. I didn't think it could be part of the vaccine because it appeared about 10 days after the shot but I couldn't figure out how I got it.  Since it didn't hurt and no one could see it since I wear long sleeves, I just made sure it didn't get worse and didn't pursue it with medical treatment or advice.  It wasn't until I saw reporting on it that I realize it was a reaction to the shot.
Child was administered an expired vaccine.  Hep B, child developed severe diarrhea that burned her diaper area.  Treating with neosporin, aquaphor and oatmeal baths.
I developed a fever of 102 the evening after getting the vaccine. I went to bed with fluids and advil and woke with not further issues.
hives for 2 days following vax oral cortisone prescribed @ ER on 15JUL97;vomited x2;no fever;