chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 04-JAN-2018, the patient was vaccinated with ZOSTAVAX lot # M041087 expiration date 03-JAN-2018 for prophylaxis. Other suspect therapies included sterile diluent. On 04-JAN-2018 the patient experienced expired product administered. The lot and expiration date of the properly stored sterile diluent was unknown. No adverse effects were reported. Follow-up was received from pharmacist on 29-JAN-2018. The pharmacist clarified that she was the reporter of the event and also stated that she did not vaccinate the patient with the expired product. The reporter also asked for a medical inquiry to be placed regarding this event. The reporter also confirmed that she had no additional information to share and was unaware of any adverse experiences with the involved patient. Additional information is not expected.
I started to have left arm pain and it felt like my arm was going numb, and it was tingling. It got worse as the night went on and I was starting to get concerned and think maybe I was having a heart attack, but I was not having any other warning signs, and I am healthy. The pain felt like it was deep in my arm, not on the surface, and it was my whole arm at the injection site. It was even worse in the morning and I finally took TYLENOL at 11am that day and the pain went away about an hour later.
Large reddened, swollen and warm area, approx. 10 cm. on R arm at site of injection.  Pt. treated for cellulitis with Augmentin and will see allergist to test for allergy to components of vaccine.
Client complained of blurred vision, clammy, pale, and sweating, 5 minutes after vaccine. Vitals monitored. Cold compresses applied and clnt given to raise BS once symptoms improved.  Monitored x 20 minutes.
Fever as high as 100.8; chills; redness, swelling, increased warmth to touch and pain adjacent to injection site greater than 1" in diameter, lasting 4+ days; moderate to severe body aches; intense headache lasting 60+ hours; diarrhea on day 4 with nausea.
nurse accidentally injected Daptacel that expired on 16May2019 to a patient on 21-May-2019/no AE; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA143977 and 2019SA143962 (same reporter).  This case involves a 5 years old male patient who was vaccinated with an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE) for Immunisation; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 21-May-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA, expiry date: 16-May-2019, via intramuscular route in the left thigh (reported as left leg).  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 holders compliance with the requirements set out in Directive and Module VI of the 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.
frozen Daptacel was administered to a patient/No AE; Initial information was received on 19-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to cases 2020SA133784, 2020SA133785, 2020SA133715 and 2020SA133787 (same reporter).  This case involves a patient of an unknown demographics who received a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] which was frozen (product storage error).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to incorrect product storage as frozen Daptacel was administered to a patient.  At the time of 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.  There will be no information available on the batch number for this case.
Bells Palsey 11/18/21 thru present Eye not closing, half smile , facial paralysis
Information has been received from a LPN concerning a patient between the age of 60 and 65 years who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640981/1050L).  Subsequently, the patient developed "severe local reactions at the injection site."  Follow up information received stated that the patient's entire upper arm became red and swollen.  Unspecified medical attention was sought.  The patient was treated with ice/diphenhydramine hydrochloride (BENADRYL).  The reporter noted that the patient recovered.  The reporter also mentioned 3 other patients between the ages of 60 and 65 years that had similar experiences following vaccination with a dose of pneumococcal vaccine 23 polyvalent (Lot # 640981/1050L) (WAES # 0204USA02771, 0306USA02582, 0306USA02583).  Additional information is not expected.
Symptoms include a fever peaking at 100.8 degrees Fahrenheit, pain at injection site, fatigue, chills, and body aches. These came on about 20 hrs after the injection. They lasted for about 8 hours and then improved significantly. By 48 hrs after the injection, they were all resolved except for minor pain at injection site (right arm).
The vaccine was given past it?s refrigeration expiration date, the date on the vial was still within date.  Another covid vaccine given to patient.
Menstrual cycle started after last cycle ended 2 days prior.  Heavy bleeding on second day,  5/7/2021.
My 5 year old grandson had developed 103.4 fever and we took him to the hospital and he tested positive on January 13th of 2022. His mom who lives with myself and my grandson and I tested positive on  the next day. I started having symptoms on the 15th which was coughing, congestion, and headache. I tested negative on Monday the 17th and then on the 22nd I had much worse symptoms and was coughing, shortness of breath, headache tired, really all the symptoms other than a fever and tested positive that day. I was out for about three weeks with symptoms.
I got a massive head ache the evening I got the shot and I still have it..  I got the shot on Wednesday.  Saturday my face, neck, and eyes broke out into a very itchy red hot rash.  Sunday I ended up going to urgent care because I became short of breath, rash was getting much worse, lips started to swell, and throat was feeling weird. Doctor wasn?t sure if it could be an adverse reaction or something else that I was having an allergic reaction to and said I should report it.  I have not changed any food, soap, lotion etc, so not sure why this happened.
Hospitalization for shortness of breath and cardiac arrest, positive for COVID on dates 5/15/2022- 5/27/2022. Treated with dexamethasone, methylprednisolone, zinc, and other IV drips in the ICU for organ support.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 69-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 10th September 2018, refer case US2019GSK054970) and SHINGRIX with an associated reaction of injection site pain (2nd dose received on 15th November 2018, refer case US2019GSK054969). On 31st January 2019, the patient received the 3rd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site tenderness and extra dose administered. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site tenderness and extra dose administered were unknown.  It was unknown if the reporter considered the injection site tenderness to be related to SHINGRIX. Additional details were provided as follows: The reporter indicated that she had a consumer that received dose of the SHINGRIX vaccine and stated that the consumer indicated that the only adverse event she experienced was tenderness at the injection site. The field representative was unable to provide any additional information. The reporter did not consent to follow up.
Arm was numb in injection site afterwards, still numb after 15 months and numbness goes down arm about 8 inches. Period stopped without any symptoms of menopausal beginnings. Period was due 8 days after second injection. May 15, 2021. Period returned in September of 2021 heavy with severe clotting. Lasted over 20 days. Has restored to being regular ( every month ) except it is heavier and containing clots each time compared to my pre vaccine mentration. In July of 2021, my right arm and hand began to itch and then it went to my feet. The itch was intense and mostly at night. It spread to my hands and then continued all over my body. Any small brush or scratching of my skin would leave dark red welts that lasted usually around 20 minutes. This was an everyday occurrence for 3-4 months.  The itching went from everyday to every other day to once every three days or so. I treated myself by taking Benadryl tablets and then switched to Claritin because I was always tired with Benadryl. My husband, who is a doctor in Chiropractics, has suggested some herbal remedies however, I did not want to start self medicating with anything other than Benadryl and Claritin. (Benadryl works best. I still itch every 3 to 4 days  and treat myself with Claritin on those days. The raised welts and redness has not returned as of December 2021. My hands constantly feel swollen and often look swollen since approximately August of 2021. I didn?t put all this together thinking of side effects of a vaccine until  late  September 2021
Information has been received from a pharmacist and a medical assistant via a company representative referring to two unspecified patients of unknown age and gender. There was no information about pertinent medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with a dose of PNEUMOVAX23 (lot # K023328, expiration date 23-JUN-2016, dose and route unknown). No concomitant medication was reported. On unknown dates the patients experienced cellulitis at injection site. The patients were seen by an unspecified healthcare provider to seek medical attention. The action taken with PNEUMOVAX23, outcome of the event and causality were unknown. This report is one of two reports received from the same reporter. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a 18-year-ild female patient who received BEXSERO. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, 1 day after receiving BEXSERO and not applicable after receiving BEXSERO, the patient experienced injection site swelling, injection site erythema, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site swelling and injection site erythema to be probably related to BEXSERO. The reporter considered the injection site swelling and injection site erythema to be probably related to BEXSERO. The reporter considered the injection site swelling and injection site erythema to be probably related to BEXSERO. Additional details were provided as follows: The age at both the vaccination was not reported. The patient received the 1st dose of BEXSERO and her arm was red and swollen. She was given the 2nd dose and redness and swelling returned. The patient had bulls eye at injection size both the times. There was no seriousness criteria (death, hospitalization, disabling, congenital anomaly, life-threatening and clinical intervention required) associated with the reported event.
3/25 overnight: chills - gone by morning; extreme arthritis pain all night 3/26: extreme headache all day, extreme arthritis pain all day; no appetite all day / 2 Tylenol tables at noon and bedtime 3/27: much improved - mild headache until about noon; appetite improved 3/28: I feel great! Arthritis pain is back to "normal".
MDS...... You allowing this to be rushed through is killing my daughter. How many deaths are because of these vaccines? How many people are suffering. The people I know that caught covid, including myself after being vaccinated are are dying from a bone cancer the vaccine gave them!! Yes I lost a few to covid but the majority are fine and not dying from cancer. I am disgusted with myself for EVER trusting the CDC or our Government!
Information has been received from a health professional concerning a 6 year old white male who on 03/21/97 was vaccinated SC in the arm with Varivax. On 01/17/02,  The patient experienced breakthrough chickenpox described as 30 lesions on the trunk and extremities. the patient recovered without any prescription drug treatment.
Within approx. 24 hours; injection site became painful, swollen, & red. Patient sought treatment on 7/23/11 at ER - she was Dx'd with cellulitis & began a course of CIPRO.
1st dose around late summer, 2nd in September; Sick the next day; This case was reported by a consumer and described the occurrence of sickness in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, COVID-19 VACCINE for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   The patient's past medical history included morbid obesity, tennis elbow, fibromyalgia, shingles (On 28th May 2021, the patient was diagnosed with shingles) and pain. Previously administered products included Valcyclovir, Prednisone and codeine.   In September 2022, the patient received the 2nd dose of Shingrix. In August 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received COVID-19 VACCINE and PNEUMONIA VACCINE. In August 2022, not applicable after receiving Shingrix and 1 day after receiving Shingrix, the patient experienced sickness. In September 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.   Additional Information: Receipt Date: 28-OCT-2022 Reporter is Comment: During an onboarding call with the Shingrix team, shared that she had received her Shingrix vaccine. The only side effect she experienced was during her first dose of Shingrix with the Covid booster and vaccine for Pneumonia. She was sick for the next day but she did not experience any reaction after the second dose. Additionally, shared that she was currently being administered hormones and was prescribed a weight loss medicine. She was previously in pain when she was prescribed additional hormones years ago, but now had more energy and was more active since being on the weight loss drug. She did not clarify the type of hormone or weight loss drug name. It was unknown if the reporter considered the sickness to be related to Covid-19 vaccine and Pneumonia vaccine. Additional Supportive Information: The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Pt was vaccinated on 3/10/23 at 1111. He received his primary monovalent first dose Pfizer. Pt has no known allergies. Pt received dose and immediately passed out. Charge RN notified. Per policy emergency called. Pt denied being taken to ER x3, O2 taken off pt, 100% @ RA. Pt remained in clinic for approximately 20 minutes before he decided to leave. Prior to leaving vitals WDL.  AMA form signed and placed in medical records. Pt advised to follow up with primary care doctor.
No adverse reactions reported In November 2022 our State Immunization VFC program did our every-other-year audits in both our offices. It was discovered at that time, that some Covid vaccines were administered outside of the 10 week expiration date (which is calculated from the date the vaccines were received from the State.)
This spontaneous report as received from a registered nurse via field employee refers to unspecified number of patients were exposed to wild-type measles. Then on an unspecified date (in 2014), these patients were given M-M-R II (therapy type, lot#, dose, route and duration were unspecified). Then on an unspecified date (in 2014), these patients developed a measles outbreak. The present status of the patients was unspecified. Additional information is not expected.
PAIN ON KNEES, PAIN ON THE SIDE AND INSIDE OF THE KNEES, MORE PAIN ON LEFT KNEE; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non drinker, and non-smoker. The patient experienced drug allergy when treated with acetylsalicylic acid.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced pain on knees, pain on the side and inside of the knees, more pain on left knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on knees, pain on the side and inside of the knees, more pain on left knee. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
PATIENT STATES THAT APPROXIMATELY 1 WEEK AFTER HER INJECTION THE AREA AROUND INJECTION SITE SWELLED TO ABOUT THE SIZE OF A SOFTBALL AND WAS SORE.  IT LASTED ABOUT 5 DAYS AND WENT AWAY
Not certain injection related but shortly after first dose began itching at nape of neck (hairline) and kept asking family to look for a reason.   3 looked and 3 found nothing but I was still itching.  I had applied some hydrocortisone, but the itch kept up and then on Easter, my granddaughter saw "little pimples" back there   It just kept up until on April 12th it was so itchy and burny that I told my husband to take a picture I could look at myself and there was a red area mainly toward the middle of the area but I feel the itch mainly on the left side near my ear looking forward.  For the last 2 days I have used Claritin and it seems to be abating somewhat.  My husband says the red is gone but I still have "itch"   Like I said it may or may not be from the shots?
Diarrhea; lightheadedness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (lightheadedness) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031821A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (lightheadedness) and NAUSEA (nausea). On 28-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency and BISMUTH SUBSALICYLATE (PEPTOBISMOL) at an unspecified dose and frequency. On 07-Apr-2021, DIZZINESS (lightheadedness) and NAUSEA (nausea) had resolved. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication reported   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: non significant follow up was received on 04-jun-2021 no new information updated.
Mom relates pt playing in toy car & suddenly fell forward.Was very stiff,pale & diaphoretic. Loss of consciousness for few seconds.Weak cry when recoverd.Taken to Dr's ofc.
After 2nd Dose 2 weeks later  Numbness in Arms Chest Pain, Short of Breath, Heart Racing
I developed severe chest pain radiating to my left arm and back, palpitations, and easy fatiguability which lasted for days/weeks. EKG, CT scan and laboratory tests  were done but they were unremarkable. Prednisone was prescribed for 5 days but even after the medication course was completed, the chest discomfort and palpitations were still present. On my follow-up appointment with a FNP,  diclofenac PO was prescribed.
HEAD CONGESTION; JOINT ACHE; MUSCLE ACHE; HEADACHE; FATIGUE; 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, and batch number were not reported) 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 the case. No concomitant medications were reported. On an unspecified date, the patient experienced head congestion, joint ache, muscle ache, headache, and fatigue. Treatment medications (dates unspecified) included: guaifenesin, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head congestion, headache, fatigue, joint ache and muscle ache was not reported. This report was non-serious. This case, involving the same patient is linked to 20220102781.
Tingling of the face Obvious swelling of the face Itchy throat ER visit- Benerdry & prednisone, 4 hours observation. Symptoms receded
Pt developed severe, stabbling HA, slight mental confusion after taking first dose of oral typhoid.
Father stated today that upon receiving the vaccine the patient immediately felt chest pain. The following few days he was exhausted with chest pain and could not get out of bed. He suspects his son had heart inflammation. He has not had this evaluated by a doctor.
A report has been received from a Physician concerning a 6 year old, Female subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on 15-Jan-2014. The physician reported that the patient had received expired FLUMIST QUARDIVALENT which started on 15-Jan-2014. The outcome of the event of received expired FLUMIST QUARDIVALENT is unknown. The report was considered to be non-serious.