chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore left arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PAIN (Sore left arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Diabetes, Neuropathy, Blood pressure high and High cholesterol. Concomitant products included Telmisartan; Atorvastatin; Lantus; Lyrica; Finasteride; Tylenol with Codeine; Carbidopa/Levodopa; Baclofen; Aspirin [Acetylsalicylic Acid] for an unknown indication.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2022-666611 (Patient Link).
Body aches; Sore throat; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on left arm on 16Mar2021 at 13:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on left arm on 23Feb2021 at 13:30 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Concomitant medications were not reported. On 17Mar2021 the patient experienced body aches, sore throat, headache. No treatment was received for the events. The clinical outcome of body aches, sore throat, headache was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 12-AUG-2020, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot number S008153 was confirmed to be valid, expiration date 31-OCT-2021 (dose, route and site of administration were not provided), for prophylaxis. On 04-AUG-2020, the administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. A digital data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022583; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
This case is linked with case number 2014SA041844., The case was received on 23 October 2013 at GPV. Initial misuse report received from a healthcare professional on 23 October 2013. This case is part of a cluster and it is linked to case 2014SA041844. A 20 months-old patient had received 0.5 ml dose of FLUZONE on an unspecified date. It was reported that the patient received 0.5 ml of FLUZONE instead of 0.25 ml resulting in an over dose. No adverse event was reported. Lost of documents held by sender: none
Headache migraine headache started after arm soreness resolved, onset was 3 days post vaccine. 7-8/10 pain level. Sx resolved 02/07/2021. took personal migraine medication for sx resolution.
none- inadvertently gave 2022-2023 flucelvax expiring 6/30/23
A report was received from a health professional on 05Dec03, concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 26Nov03. On 26Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Cross reference with: PJP200301247, PJP200400085, PJP200400086.
This spontaneous report as received from a certified medical assistant via a company representative refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, at the age of 11 year old, the patient was vaccinated with the second dose of unidentified Merck hpv vaccine (name, dose, expiration date and lot number not provided) (reporter was not sure if it was GARDASIL or GARDASIL 9 for human papillomavirus prevention. On an unknown date, the patient had an unspecified allergic reaction after the second dose of unidentified Merck hpv vaccine. On an unknown date, the patient developed a fever of 101 degrees and had aches. The outcome of the adverse events was unknown. The relatedness between the adverse events and unidentified Merck hpv vaccine was not provided. Additional information is not expected as the reporter did not wish to be contacted.
On May 25, 1999 the patient developed chickenpox with approximately 10-12 lesions.
4"x6" nodule; redness, swollen, warm to touch. Went to after hours clinic same evening. Given Atarax-followed up with PCP 9/9/02.
Patient was here for vaccinations and Physical today. About 15 min after  vaccinations, while still in waiting room, mom noticed extreme redness, hives  and swelling on face, cheeks, neck and back. Patient was brought to exam room,  Vital Signs and Oxygen level were assessed. O2 level was 99% and no difficulty  breathing, Benadryl IM given x1 per protocol. Patient tolerated well. Vital Signs monitored  throughout. O2 level maintained above 95% on Room air. Patient was assessed by  Dr. and patient started returning to baseline skin color. Patient was  monitored for an additional 30 min and we discussed with mom the need to just  watch for additional symptoms today. Advised to return to ER or MD if needed,  but no further evaluation needed unless additional symptoms occur. Mom  verbalized understanding and states she is comfortable now bringing him home at  this time.
Headache, Myalgia, Arthralgia, UrticariaPruritus, Chills, fever, fatigue, swollen glands, pain Narrative:
A round circle the diameter of a 50 cent piece where the vaccine was administered. It is still there this day, although faded.
Patient received 2 doses of  Spikevax Moderna 23-24, 09/28/23 and 10/04/23. Pt did not have any  reaction with the first dose of Spikevax.  When pt received Spikevax and Fluzone, she felt a little under the weather for about 1 day.  No other issues, confirmed with pt 10/09/23.
Pt received 0.5 ml FLUVIRIN Monday 9/13/10 around noon. Pt receives flu vaccination yearly without adverse events. Pt returned to pharmacy 9/16/10 around 4-5pm saying he blacked out for a few seconds while driving around a corner at 1am 9-16-10 delivering newspapers. He claims he could not see for a few seconds. No motor vehicle accident occurred or property damage. Pt also states it could have been due to his eye implants. He denied my request to call MD. Pt states no further problems.
DVT behind the right knee that developed 3-4 days after the vaccination.  I then developed a pulmonary embolism on 01/01/2021.
pt recvd vax & devel high fever; seen at hosp,having staring spells;
Burning sensation during administration (L) deltoid. Red rash circular center of chest - 4 to 5 inches. Took antihistamine which relieved itching. Took BENADRYL 9:30 pm 10-8-15, 10-9-15 5am. Chest, sides, back, armpits, base of neck with itching. Took antihistamine and came to work. Saw PMD 10-9-15 and recv'd treatment with steroids and antihistamines and improved.
Flu like symptoms, rash near injection site. Started within 24 hours of injection. OK 5-19-16.
tingling in right arm and leg, pain in left arm and leg, weakness in left arm and leg, swollen right side of face, chest pain, and fatigue
Facial rash that only goes away on corticosteroids or calcineurin inhibitor.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/15/2023 PSEUDOANEURYSM, UNSPECIFIED SITE
I was 4 days into my regular monthly reoccurring menstrual cycle on 1/24/22 when I received the first dose of the Pfizer covid vaccine and 30 minutes later my period just stopped out of nowhere and for over 30 years I never had an issue with my cycle. So my period stops and doesn?t return until 4/5/2022 and I am literally still bleeding as of today 4/27/2022 and even with medications like MEDROXYPROGESTERONE 10 MG and NORETHINDRONE 5 MG my period is not stopping.
This case was reported by a pharmacist and described the occurrence of wrong vaccine administered in a newborn subject less than one day old of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline) for prophylaxis. On 21 January 2008, the newborn subject inadvertently received an unspecified dose of Fluarix (unknown) instead of an intended Hepatitis B vaccine. This was considered to be a medication error, as Fluarix is not indicated for use in subjects under the age of 18 years. The newborn was hospitalized following birth and it was unclear at the time of reporting whether the medication error would prolong the subject's stay in the hospital. The reporting pharmacist stated that no patient chart was available, but no adverse events had occurred at the time of this report.
Vaccine site: induration and erythema, pain and hot to touch extending 4-5 cm from injection site. Mild cellulitis.
Information has been received from a physician's assistant concerning her friend's daughter who on an unknown date was vaccinated with the first dose of GARDASIL (lot # not given). On an unspecified date, after receiving GARDASIL, the patient experienced idiopathic thrombocytopenic purpura "ITP". Subsequently, on an unknown date, the patient recovered. The patient sought unspecified medical attention. It was reported that the patient will not receive further doses of GARDASIL. Upon internal review idiopathic thrombocytopenic purpura "ITP" was considered to be an other important medical event. Additional information has been requested.
no additional adverse events; the patient has not had seizures since ROTATEQ was administered; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. They were on a keto (sucrose-restricted) diet and had seizure if had too much sucrose. No information regarding the patient's concomitant therapy and drug reactions or allergies was provided. On 22-JAN-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number 1658806, expiration date of 06-OCT-2020; dose was no reported). Since rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administration, the patient had not had seizures. No additional adverse events were reported.
Patient had dizziness, BP 111/54, HR 71, RR21, patient released in stable condition 30 minutes after immunization in stable condition
PATIENT HAD SCHEDULE FOR MENINGITIS WITHOUT SPECIFYING WHICH ONE. AFTER ADMINSTERING TRUMENBA HER FATHER SHOWED ME A TEXT FROM SCHOOL REQUIRING HER TO GET MENVEO
On 10/20, I woke up around 2am & noticed thst my face & lips were swollen. I knew i had an allergic reaction to something & I know that I hadn't eaten anything different. The only thing different was the fact that I took the 1st dose of the Covid-19 vaccine.
Patient received 2nd dose of GARDASIL and then had a rash from head to toe that lasted for 3-4 wks.
1/24/19 received Varicella vaccine in left arm and waited 20 min at health center to watch for initial injection reaction, which was none. (pt also received MMR #1 and Hep A #1 in right arm at same time of Varicella administration). 1/25/19 pt woke up in morning to right arm swelling, itching, pain and redness. Pt did not consult clinician or take any medications. 1/26/19- pt decided to self medicate with BENADRYL, which did not help. 1/27/19 pt woke up and noticed "red bumps on jawline" and "felt the need to clear her throat and stated possibly more difficult to breathe". Pt went to urgent care facility and received Dx of allergic reaction to vaccine. She was prescribed Prednisone 50mg PO, ZYRTEC and Famotidine. Pt states "within hours the rash on my face resolved. Pt denies any Shortness of breath or dyspnea. 1/28/19 pt saw Dr. at Health Center where vaccine was given. Some local swelling, warmth noted on right tricep but symptoms are resolving. No Shortness of breath or dyspnea. Rashes resolved. Per Dr., discontinue prednisone today due to potential reaction with varicella and MMR vaccine to reduce their effectiveness. No other medication or treatment needed. Pt to return as needed for additional needs or concerns.
10/11/06 3:00pm hives under arm went to hospital, got Benadryl, then hives spread over abdominal area, under arm, chest, itching on leg and stomach. 10/13/06 cleared up.
@ 1/2 hour after vaccine administration c/o flushing of face with temp elevation to 99.6 F.  Also reported vomiting.  Vomiting and facial flushing continued through the next morning.
Pain near bunion on right foot. Resumed Personal Training on injection day +4. Experienced pain on day +5, +6.  Vegan yo take Voltaren topical.
This spontaneous report was received from a healthcare worker refers to a 36 year old patient (gender unknown), who was a healthcare student. Pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 16-SEP-2015, the patient came into the office to receive MMR II titer and was mistakenly administered (Oka/Merck) VARIVAX, for prophylaxis, (lot #, dose, frequency and route not provided). Reporter did not know if the patient had chicken pox in the past or if the patient was previously vaccinated with (Oka/Merck) VARIVAX. No adverse symptoms reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has  been requested.
RASH ON LEGS AND SPREAD TO TORSO WHILE IN OFFICE. NO FEVER, NO COUGH, POSITIVE ITCHING.
Vasovagal reaction to vaccine, dizziness, diaphoresis, pale.  Had client lie down and raised legs.  Lasted 4-5 minutes.  Completely recovered
pt recv vax in late summer to early fall 1994 & fainted & fully recovered w/o tx;
Pt s/p Covid-19 vaccination administration. While this nurse was completing the documentation, the pt slid self to the floor from a sitting position. No head strike or injury occurred. Pt able to stand by himself and sit back in chair where he was monitored for 25 additional minutes. VS obtained and were WNL. Pt stated "I feel okay and this has never happened to me before". Pt denies any health related conditions. Pt was able to ambulate safely and independently out of the facility.
Nerve pain/muscle pain from upper shoulder to bicep. Painful during day and while trying to sleep. Lifting weights and stretching changes nothing.
Information has been received from a pharmacist concerning a female with asthma and no drug allergies who on 09-AUG-2006 was vaccinated with a 40 mcg IM dose of Recombivax HB. There was no concomitant medication. A few days after vaccination the patient developed bronchospasm and flu symptoms. She also lost her appetite and had not been able to eat well ever since vaccination. It was reported that there were no other symptoms. It was reported that on 08-SEP-2006 the patient still continued to have problems from the overdose with Recombivax HB. The patient continued to have bronchospasms that did not resolve with medication (inhalers). She was referred to a respiratory specialist on 07-SEP-2006. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a female pharmacist of unknown age refers to herself. The pharmacist reported that she herself was exposed to a spillage of reconstituted ZOSTAVAX (dose unknown) on 30-JAN-2014 when it spilled from the vial onto the skin of her hand. She reported no adverse experiences. This is one of several reports received from the same source. Additional information is not expected.
Terrible chills,  dry heaves, acute hip pain. Lasted about 5 hrs.
Developed meningitis within 1 week of receving COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of MENINGITIS (Developed meningitis within 1 week of receving COVID vaccine) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENINGITIS (Developed meningitis within 1 week of receving COVID vaccine) (seriousness criterion medically significant). At the time of the report, MENINGITIS (Developed meningitis within 1 week of receving COVID vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bacterial test: (Negative) Negative. On an unknown date, Lumbar puncture abnormal: showed active inflammation. On an unknown date, Viral test: (Negative) Negative.     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.   No concomitant medications were reported. No treatment medications were reported.  Company comment-This spontaneous case concerns a 4-year-old male child with no medical history reported, who experienced the unexpected serious (medically significant) AESI event of Meningitis that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date was disclosed. It was reported that patient developed meningitis within 1 week of receiving COVID vaccine. Lumbar tap done on an unknown date showed active inflammation with negative bacterial culture and viral screening. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 4-year-old male child with no medical history reported, who experienced the unexpected serious (medically significant) AESI event of Meningitis that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date was disclosed. It was reported that patient developed meningitis within 1 week of receiving COVID vaccine. Lumbar tap done on an unknown date showed active inflammation with negative bacterial culture and viral screening. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
side effects/I have side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects/I have side effects) 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 VACCINATION COMPLICATION (side effects/I have side effects). At the time of the report, VACCINATION COMPLICATION (side effects/I have side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Initially arm sore and tender in injection site and hurt to move for the first 24 hours. Within 30 hours, red area appeared at the injection site and continued to grow and was hot to the touch and extremely itchy. By the 6th day about 2/3 of my upper arm was red, itchy and hot to touch. Went to urgent care and given a prescription for Clindamycin (300mg) and told if it continued to grow to go to the ER. Woke the next morning and now the entire upper arm and about 1.5 to 2 inches past my elbow was now red, itchy and hot to touch. Went to ER and they did test my blood and electrolytes and all came back normal which the doctors thought that was odd due to the amount of my arm that was inflamed. Proceeded to take my prescription and the arm seems to be healing fine.
09/16/2019 10:42 (1 hour 20 minutes post vaccination) Pt presented from MH apt w/ welts to bilateral arms and abdomen and lower back. Provider assessed. Issues 25 mg Benadryl orally at 1030. Administered 40 mg Depomedrol w/ 4 mg Decadron IM to right dorsogluteal at 1040. Pt tolerated well. States the itching has subsided. Pt will go home and take more Benadryl along w/ ranitidine per DO. Pt advised should throat start getting tight, tongue start to swell or should he feel short of breath to go straight to ER. Pt v/u and agreed to plain.
Information has been received from a nurse concerning a 24 month old patient who on an unspecified date was vaccinated with at least one dose of VARIVAX (Merck) (Lot # and route no reported). The nurse reported that the patient on an unspecified date came down with chickenpox. At the time of the report, the patient outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
injection was given below deltoid and aspiration was not done,  upon withdrawal of the needle blood shot out and continued to bleed until pressure was held for 2 minutes. approximately  20 minutes later I started feeling very dizzy and lightheaded and having tightness across my chest.  I then walked back down to employee health and 20 minutes later went to the ER because symptoms had not resolved.  was found to have new onset PVCs which did not resolve after 1L bolus of NS I was observed for 5 hrs then discharged home to follow up with cardiology.
Report of injection site reaction, rash, edema, thigh hot to touch, causing pt to limp.
Splotchy rash that covers both breasts and underarm area, and covers more area on the left side. Not itchy.