chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My doctor had me start Allegra several days before reviving the injection and then continue taking it for up to 2 weeks after injection.. I was instructed to take Benedryl 2 hours before the injection and continue every 6 hours for a 24 hour period.  The pharmacist suggested ibuprofen for inflammation, so I took that as needed. Continued Allegra as instructed.   When I woke up on Tuesday, October 19th, the itchy hives rash was observed on my neck, chest, stomach, back, arms, thighs and pelvic area. Benedryl was started again. Hydrocortisone was used as needed.   Thursday, October 21st- rash is practically gone. But still itchy. Hydrocortisone used as needed.
Initial information received on 02-Aug-2018 regarding an unsolicited valid non-serious case received from a Physician. This case involves a 6 years old female patient who received an expired dose of vaccine DAPTACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 02-Aug-2018, the patient inadvertently received a 0.5 ml single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5014BA as fifth dose in series. It was a case of actual medication error due to Expired vaccine used. It was unknown whether patient had any adverse event. 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 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 concerning a 28 year old female who in 10/1999, was vaccinated with pneumococcal vaccine 23 polyvalent. In 10/2000, the pt was re-vaccinated with this same vaccine. Subsequently, in 10/2000, post vax, the pt experienced arm swelling, hives on neck and face and the pt was hospitalized. The pt was treated with steroids and Benadryl and she "felt better." The pt reported that as of 11/6/00, she was still "unable to breathe properly" and her arm was still sore. Additional information has been requested. F/U information indicated that the pt was treated with Pnu-Immune 23 and not Pneumovax 23 as previously reported. Therefore, WAES #00110589 id being deleted from our files on pneumococcal vaccine 23 polyvalent.
Information has been received from a registered nurse (RN) concerning a 18-year-old white female who on 26-JUL-2005 at 15:30 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot# 647951/0892P). On 11-AUG-2005 to 14-AUG-2005 the patient complained of a headache and itching (Itching also reported to have began on 15-AUG-2005). It was reported that her mother noticed pox on 14-AUG-2005. On 17-AUG-2005 the patient was seen by a physician and had approximately 20 lesions on her body. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
No adverse effect reported.; GARDASIL 9 that underwent a temperature excursion was administered / temperature -0.03 C; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 14-JUL-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1621931, expiration date 26-JAN-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in a temperature of -0.03 degree Celsius (C) for 21 hours 30 minutes. No previous temperature excursion was reported. Digital data logger was involved. No adverse effect was reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient involved do not experiencing symptoms at this time; Medical Assistant calling to report administration of expired VARIVAX.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 07-AUG-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml, two doses series, lot #U022321, expiration date: 15-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided). Patient involved did not experience symptoms at this time.
Person under the age of 18 was inadvertently vaccinated with Janssen Covid-19 vaccine.  No adverse effects were noted.
pt recvd vax 1APR92 @ 230PM pt given APAP & by 4PM pt adm to hosp because mom noticed pallor , cyanotic episode; paramedic called & pt taken to hosp; t99.2 had leukocytosis;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot number 670818/0662AA; expire date: 04-AUG-2012) (vaccination site unspecified) on 01-OCT-2012. No adverse events experienced. It was unknown if the patient had sought medical attention. Additional information has been requested.
Ran high fever for 4 days. Lethargy, loss of appetite. Doctor advised TYLENOL.
Minor male patient. At the time of being vaccinated he appeared sweaty, cold to touch. The vaccinator indicated that he was ventilating. Vital signs were taken. BP60/40, dextrose 79. He was given brown sugar and applesauce and in 10 minutes he was monitored again for vital signs. BP 70/40 and glucose was 110. He positioned himself semi-folded with his head down and oriented himself. According to him he was feeling better outside by raising his head. He positioned himself in semi-lumbar to help increase pressure. When the ambulance arrived for transfer to the nearest hospital he was stable.
Swelling around collar bone; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After received Shingrix patient experienced swelling around collar bone.
On 10/28 felt warm at night, coughing. Saturday morning, dizzy, tired, very tired, couldn't get up, very lethargic, fever from 99-101. TYLENOL will bring fever down and then it will go back up after 4 hours. On the 10/31 went to doctor who prescribed Z PACK but did not help much. Fever did not go down, running fever until this morning. Doctor visit on 11/1 who mentioned that it is an upper respiratory viral infection. Swab test came back negative probably to rule out pneumonia. Scheduled to go for a chest x-ray. Prescribed some decongestant on 11/1 to control coughing. Abdomen tender and sore from coughing. So far fever broke, this morning, and decongestant is controlling the coughing. Still a little dizzy and tired - an improvement from the other day. Got the same vax last year with no problems.
vaccine expired 7/13/2022  used 7/15/2022 no adverse reaction reported as of 7/27/2022
Patient received Pfizer formulation for age 12+ when patient was 11 years, 4 months of age. Patient did NOT have an adverse reaction.  Mother of patient was notified of error. Nurse followed-up the next day and mother reported patient only had a sore arm. Mother was encouraged to contact nurse with future concerns and/or to come to ER if patient began to exhibit signs/symptoms of adverse reaction.
3/4/2021: -Woke up with headache (best compared to a dehydration headache but had frequent urination that day) and sore arm -Body aches and fever started 24 hours after first dose of vaccine. Fever climbed to 102. By 18:30, fever had broken and all that was left was the headache -Noticed my heart rate was elevated. Smart watch said it was 86bpm resting 3/5/2021: -Woke up with headache and sore arm again -Had a doctor's appointment at 11:45 unrelated to vaccine and resting heart rate was 98bpm -Around midnight, I decided to take a shower to relax because my heart rate was making it difficult to fall asleep. **After the shower, I had a sharp pain in my chest and passed out.***
Information has been received from a 40 year old female registered nurse with a codeine allergy but no other medical history who when she administered Rotateq (human-bovine) to a baby, the baby sneezed (WAES#0701USA00705) and some of the vaccine went into her eyes and mouth. Unspecified medical attention was sought and the RN flushed her eyes with water. No laboratory/diagnostic tests were performed. The RN reported that she developed a little bit of redness in her eyes which she thought might be from the flushing. The RN indicated that at the time of the event she was not on any medication. At the time of this report, the RN was noted to be recovering. Additional information has been requested.
Patient became lightheaded and flushed and warm. Vasovagal reaction with no loss of consciousness. Patient has a history of reacting to injections.
This spontaneous report was received from a registered nurse and refers to unspecified multiple patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9, lot number M034437 with expiration date 03-FEB-2019. The vaccines were exposed to previous temperatures excursions; also on 07-MAR-2017, the vaccines were exposed to temperature of +32.3F (Fahrenheit) during 5 hours and 7 minutes. Additionally on 20-MAR-2017, the vaccines were exposed to +23.4F (Fahrenheit) during 9 hours and 53 minutes. Data logger was filled. No adverse symptoms were reported. Additional information has been requested.
pt recv vax AM of 4MAY95- 3 hr p/vax devel t101, vomited & c/o h/a; mom gave Tempra p/consulting w/MD & by 4Pm pt taking fluids, fever dec & no h/a, alert & playful; 5MAY95 pt remains well w/o side effects;inadvertently admin double dose
Two days after vaccines, pt developed localized erythema, warmth, swelling, tightness in arm. No pain, no tenderness; no fever. No other concern. BENADRYL (12.5/5ml) approximately 15ml PO given once in office. Mom advised to bring him for eval if it worsens. To repeat BENADRYL tonight & tomorrow along with TYLENOL.
Went bald after a booster dose of the Moderna Covid19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Went bald after a booster dose of the Moderna Covid19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no allergies reported.    In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ALOPECIA (Went bald after a booster dose of the Moderna Covid19 vaccine). At the time of the report, ALOPECIA (Went bald after a booster dose of the Moderna Covid19 vaccine) outcome was unknown.     No concomitant medications were reported.  It was reported that the patient received booster dose in Dec-2021 and 30 days after she started noticing the baldness. Patient received treatment, no oral medications.
Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022; administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients) and PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients) and PRODUCT STORAGE ERROR (Administered the vaccine from a vial that was open on 01-Jun-2022 stored in the refrigerator on same day and administered on 27-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient has no known allergies. No concomitant medication were reported. The vial was initially stored in the refrigerator on 1Jun2022and was opened on the same day. The vial didn't undergo any temperature excursions. No treatment information were provided.
On Saturday, I woke up to my right arm - at injection site area - was itching. I woke up to numerous nose bleeds. I'm not prone to nose bleeds. Also - consistent since Saturday, Diarrhea; muscles aches; fatigue; vomiting. Problems with keeping liquid and food down now - just started a couple of days ago. Dr called me on Friday -I was doing okay; On Monday - he called again and I wasn't doing well. Have spoken to my doctor each day. And now  (since two days ago) it feels like my skin is tearing apart and burning and that the inside of my bones are on fire. At the same time, I couldn't keep food and liquid down anymore. Autonomic immune system is in fight response since Saturday. Haven't been able to get out of bed for last two days. Diarrhea has worsened. - Have been taking Zofran - nausea med for the last two days. To subdue the vomiting. Have a new medication that I am starting today to subdue the diarrhea - can't remember what it's called. Trying to make sure it doesn't go into an autonomic crisis. Only Telemed visits so far - video appts. Have had several fevers doing this time - currently at 100 but went up to 103. I have gone to low grade too and means I have not been doing well at all - on Saturday to Sunday. (Went to high grade - Mon, Tuesday, Wednesday).
Information has been received from a Nurse Practitioner concerning a female patient who on 17-JUL-2007 was vaccinated with the first 0.5 ml dose of GARDASIL (lot #655617/1447F). On 18-JUL-2008, the patient was vaccinated with the second and third dose of GARDASIL respectively. It was reported that the patient had high risk PAP smear after getting all three doses of GARDASIL. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Follow up information received from a nurse practitioner via medical records indicated that the patient was a female student. On 17-JUL-2007 the patient was vaccinated with first dose of GARDASIL (lot # 655617/1447F), intramuscularly into her right arm. On the same date the patient was vaccinated with a first dose of MENACTRA (lot # U2182AA), intramuscularly into her left arm. On 18-SEP-2007 the patient received a second dose of GARDASIL (lot # 658563/1063U), intramuscularly into her left arm. On 21-JUL-2008 the patient received a third dose of GARDASIL (lot # 660391/063X), intramuscularly into her left arm and a second dose of varicella vaccine (Merck), (lot #659227/1510U), subcutaneously into her right arm. On 24-FEB-2010 the patient had a cervical HPV, high risk smear which came back positive for high/intermediate risk HPV types 16/18/31/33/35/39/45/51/52/56/58/59/68. The patient's immunization record included three doses of HEP B vaccine (manufacturer unknown) on 30-JUN-1994 and 27-MAR-1995, a first dose of varicella vaccine (Merck) (manufacturer unknown) on 31-MAR-2004, four dosed of POLIO (unspecified) on 23-AUG-1994,  23-NOV-1994, 25-JAN-1995 and 07-SEP-1999, two doses of MMR vaccine (manufacturer unknown) on 08-SEP-1995 and 07-SEP-1999, a dose of DTAP on 14-JUL-2006, three doses of influenza (unspecified) (manufacturer unknown) on 23-AUG-1994, 23-NOV-1994 and 25-JAN-1995; and five doses of DTP on 23-AUG-1994, 23-NOV-1994, 25-JAN-1995, 22-DEC-1995 and on 07-SEP-1999. No further information is available.
Day after vaccine, dyspnea, shortness of breath, body aches. Lasting 2 weeks
pt recv vax;became fussy & started v;sx persisted  & pt adm for hosp;had upper GI endoscopy showing mild esophagitits & upper GI x rays series showed poor gastric emptying;
This spontaneous report was received from a registered nurse concerning an unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. No symptoms were reported. Follow-up received. Lot# of RECOMBIVAX HB were reported as : lot# 1741AA, expiration date 27-JUN-2014 and lot# H107304, expiration date 11-JUN-2015. RECOMBIVAX HB was administered to a 2 month old patient, gender unspecified. This is one of the several reports from the same source. Additional information has been requested.
Nausea, headache, fatigue,  periorbital Petechial rash, scalp/hair tenderness, tender right arm at injection site.
Patient said his arm was in a little pain after his vaccination.  He also received a Prevnar vaccination in the left arm at the same time, but did not have any pain in that arm.
redness and itchiness on the injection site; redness and itchiness on the injection site; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number unknown), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the COVID-19 vaccine on Wednesday (06Jan2021). Everything was fine, she sat there for fifteen to twenty minutes and then left. This morning (08Jan2021), patient woke up with redness and itchiness on the injection site where the shot was. Patient asked if her side effects are expected and will it go away, and should she be concerned. The outcome of the events was unknown.  Information on lot number/batch number was requested.
Evening around 11 hours after the vaccine started feeling achy. By around 2-3am severe chills and my skin hurt and became extremely sensitive (not muscle, the skin itself). By 8 am bones and muscle started aching. Chills broke around 9am. Bones and muscle aches lasted until around 2pm, and skin ache gradually centered around back, hands, and especially right arm. That faded gradually until I felt well around 10pm.
arm  soreness- the upper arm was sore for a couple of months lost use of my arm- I couldn't lift or carry anything.
I had my vaccination on 04/22/2021. I started having leg cramps a couple days after. I would go to bed and the pain was present within a few minutes. I take 2 of the Highland medications.  The pain was not present during the day. It would wake me up in the middle of night with pain. It was present daily, at night. I do have history of a lower back injury 2009. I try not to sit longer then 25 minutes and walk around. I had appt with PCM via zoom. The doctor stated for me to ice it and would have ultrasound if it repeated. The pain subsided.
Patient received J&J COVID vaccine on 03/26/2021. He received a second J&J COVID vaccine on 05/20/2021. He stated he wanted an "extra dose" to continue to "build his antibodies."
On the morning of 4/1 the patient presented to the hospital for evaluation of 12 hours of chest pain, found to have markedly elevated troponin, concerning for myopericarditis.
At 9:00 PM started with chills for about an hour, headache, stomach hurt, lost appetite and food and water did not taste good just like when she had COVID, which was 10/13/20.  Couldn't sleep either.  Just took OTC medicine.  Now feeling better about 10:30-11:00 this morning, but still does not have an appetite.
I started having chest pain. It would come and go. I check my blood pressure it was 180/92 on Dec 3rd. I show my doctor on that following Tuesday. She prescribed me medicine.
Redness, warm, and swelling at site of injection starting about 12hrs later. Increasing redness and swelling over the next 24 hrs to 15cm x 20cm covering entire anterior thigh. No fever, able to walk without pain. Treated with Prednisone.
72 yo female visited via telemedicine with the presence of her son for evaluation of a generalized rash on her chest, abdomen and extremities. Rash started from her arm and gradually spread out of her body. She had a mild sore throat which was resolved. No tongue swelling or lips involvement no SOB or cough. Benadryl 25 mg q8h recommended plus medrol dose pack. Signs and symptoms of Angioedema were given for possible ER visit.
Approximately 29 hours after the vaccine I developed fatigue, myalgias and chills.  Lasted until I went to bed that night (4 hours or so).   Resolved as of when I woke up the next morning.
This spontaneous report was received from a medical assistant and refers to a 26-year-old female patient. The patient had a history of kidney stones, no previous history of reactions to vaccines or blood draws, concurrent condition of primary hyperparathyroidism and no concomitant medications. On 14-DEC-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscular injection, lot # N017833 with expiration date on 16-NOV-2019 as a prevention of human papilloma virus (HPV). On the same day, about 2 minutes after the vaccine was administered, the patient started feeling dizzy and lightheaded. The medical assistant laid the patient back, as she was looking like she was near syncope. The reporter stated, the patient felt very cold to the touch at that time. Subsequently, the patient blacked out for about 3 seconds. When she woke up, she said it felt like it had been minutes since she blacked out and did not remember what happened. The patient stayed in the office until she felt better. The patient did not receive any treatment for the adverse events. The patient had unspecified bloodwork performed on 14-DEC-2017 (results were not provided). The outcome of dizziness, coldness to the touch and loss of memory was not reported. The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the event of blacking out was considered to be medically significant.