chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vaccine was mistakenly taken instead of Flu vaccine; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna vaccine was mistakenly taken instead of Flu vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (Moderna vaccine was mistakenly taken instead of Flu vaccine). On 28-Apr-2021, WRONG PRODUCT ADMINISTERED (Moderna vaccine was mistakenly taken instead of Flu vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that he did not had any reactions to the two doses . No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 29-JUN-2021 and Reporter information updated, Suspect vaccine dosing details were updated and Patient course of events were added din narrative
Vasculitis of hands. Patient presented redness, pain and itching of hands and palms intermittently starting approximately 4 weeks post-vaccination.
HEART PROBLEMS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had been tested months before and was healthy. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced heart problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart problems was not reported. This report was non-serious.
Dec 2nd- Ear pain Lt side sharp & deep, blurred vision- Eye won't close, tearing, mouth drooped to side Lt nostril constanly running, muscle twitches under eye and above lip, difficulty chewing & swallowing. Dec 4th E.R. visit Medical records state paresthesia, facial paralysis. msv
About 10 days to 2 weeks after the vaccine received, patient began experiencing fatigue, pain in legs that progressed to arms and more generalized, numbness and tingling, weakness and vision problems.  States her mother-in-law, husband and 4 year-old son is is also received their H1N1 vaccines the same say and also complained of symptoms.  States she went to the doctor in December, 2009 and Dr told her Guillain Barre' could not be ruled out unless he did further testing.  Patient did not want the testing and therefore has not returned to the Dr.  However, now, one year later, she is still experiencing the same symptoms and wanted to report them, in case other similar reports have come in.
It is not an adverse reaction. patient wrote on the consent form that he had moderna  as the first dose. he did not bring his cdc card. when we tried to bill the second shot , it turned out that he actually  got  Pfizer as his first shot.
24 hours after receiving vaccine patient developed left sided lower back pain and vomiting. Pain radiated to left hip and partially up her side.  She had an emergency room visit and the physician did a work up to rule out an incidence of kidney stones.  All testing for kidney stones was negative.  At the time of incident reporting (12/11/22) patient was still experiencing pain but to a lesser degree.  The symptoms were reported by her husband with follow up with patient the next day.
Injection site inflammation and swelling 7/16 woke up with fever of 101.0 High fever, body aches, nausea, throwing up every hour on the hour    10:15 am Fever was 99.7 - Dr thinks it was an allergic reaction to the tetanus . she had had a reaction once before ? nausea and threw up but nothing like this. Dr called in Zofran for her. - 705pm 101 ? no matter what she takes will not go down ? super achy  7/17 7am today, woke up drenched in sweat last night, temp down to 99. Woke today with killer headache, eyes hurt, temp back up to 101.6
16 year old patient received 1st dose of Menveo on 05sep12019 (12yrs & 3 months) and a 2nd dose on 12May2023 (15yrs & 11 months). Got it 4 months early.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose of Menveo on 05sep12019 (12yrs & 3 months)).   On 12-MAY-2023, the patient received Menveo. On 12-MAY-2023, an unknown time after receiving Menveo, the patient experienced drug dose administration interval too short (Verbatim: 16 year old patient received 1st dose of Menveo on 05sep12019 (12yrs & 3 months) and a 2nd dose on 12May2023 (15yrs & 11 months). Got it 4 months early.).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 24-Aug-2023 Health care professional (HCP) did not have the lot and expiry. The medical assistant reported that a patient received 1st dose of Menveo and a 2nd dose of Menveo 4 months early, which led to shortening of vaccine schedule. The reporter consented to follow up via postal mail
Left arm was red and swollen from shoulder to just below elbow. No pain, tenderness or discomfort.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient received vaccinations with improperly stored VARIVAX dose number 1 on 14-MAY-2012 from lot # 1273AA (dose and expiry date unknown), and dose number 2 (dose unknown) on 15-JUN-2012 from lot # 671881/1907AA with expiry date of 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Shingles - neuropathy started on day 3 and rashes started on day ~6
The next day of vaccine I got a rash it started on my arm then it progress to my body except my face, palm of my hands & bottom of my feet. 7 days later I got ptosis on my left eye. I went to the doctor on 1/3/2021,  1/8/2021 & 1/25/2021. The doctor got me on medication 50mg of Benadryl every 4hrs 25 mg of atarax every 8hrs , added topical cream. peterson oral & pepcid twice a day. Everything went away after 30 days.
No additional AEs; temperature excursion for VARlVAX; This spontaneous report was received from a nurse referring to a 2-years-old patient of unknown gender. For all the patients, the concurrent conditions, medical history and concomitant medications were not provided.  On 14-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (strength, dose, route, frequency, were not provided) for prophylaxis; Lot No. U015682 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 18-MAY-2023, and upon internal validation established as the same.  The nurse reported that the vaccine dose was administered on 14-SEP-2021 and there was a temperature excursion for varicella virus vaccine live (Oka/Merck) (VARIVAX). The product experienced an excursion of 4 Celsius degrees (C) from -10 C to 8 C for 20 minutes on 07-SEP-2021 during the transport; and of 4C from -10 C to 8 C for 20 minutes on 09-SEP-2021, again during transport. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of four reports received from the same source.; Sender's Comments:  US-009507513-2109USA005618:reference TE number : 02017200 US-009507513-2109USA005628: US-009507513-2109USA005632:
Pt. has red hot bump on (L) arm where vaccine was given & large red hot lump on (R) arm.
needle came loose and some of the vaccine spilled out; needle came loose and some of the vaccine spilled out; she is unsure if the patient received the entire dose; This spontaneous report as received from a nurse 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 08-APR-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml (lot #U022320, has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 15-JUL-2023), administered for prophylaxis (route of administration were not provided). The nurse said that while administering a dose of varicella virus vaccine live (oka/merck) (VARIVAX) to a patient, the needle came loose (needle issue and device connection issue), and some of the vaccine spilled out. The nurse also reported that she was unsure if the patient received the entire dose (underdose).
pt recv vax 27MAY97 & 29MAY97 parent noticed that lt shoulder was warm, red & swollen @ site of inj;tender @ inj site;
Unable to fully extent her arm past the 90° angle/her arm is very stiff, she can rotate it, but can't extend it; This is a spontaneous report received from a contactable consumer (Patient, reported for herself). A 19-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was unknown), dose 2 via an unspecified route of administration, in arm left on 29Apr2021 15:00 (at the age of 19-year-old) as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated she just knows her family has a history of high blood pressure, but she is in perfect health. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was unknown), via an unspecified route of administration, in arm left on an unspecified date 09:00 (at the age of 19-year-old) as single for COVID-19 immunization. The patient did not get any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not report any side effects prior vaccination. The patient did not administer additional vaccines on same date of vaccination. The patient experienced unable to fully extent her arm past the 90 degree angle/her arm is very stiff, she can rotate it, but she cannot extend it on 30Apr2021.  The patient caller reported being unable to fully extent her arm past the 90 degree angle after getting the second dose of the Pfizer-BIONTECH COVID-19 vaccine.  She explained the affected arm is where she received the vaccine. She asked if her symptom was reported as a side effects from the vaccine, and how to treat it. Patient stated that she visited an emergency room on Saturday and they gave her FLEXERIL, a muscle relaxant, and it has not really done much. Caller stated FLEXERIL is 5 mg twice a day by mouth. Patient stated she took FLEXERIL and she is been taking Aleve too but it is the Aleve for back and muscle, she thought it is 50mg or something around that. Seriousness of the event was reported as serious, medically significant. The outcome of event was not recovered.  Information on lot/ batch number has been requested.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm, appetite absent, malaise, shivering, myalgia, fever and low blood pressure. On an unknown date, the outcome of the pain in arm, appetite absent, malaise, shivering, myalgia, fever and low blood pressure were recovering/resolving. It was unknown if the reporter considered the pain in arm, appetite absent, malaise, shivering, myalgia, fever and low blood pressure to be related to SHINGRIX. Additional details reported as follows: The patient experienced a sore arm, fever of 101 degrees F, loss of appetite, low blood pressure defined as 90 by 60 and unspecified myalgias. The events improved on day 3 after the injection. The patient was given the injection at an unknown pharmacy, but the medical office of the patient was the reporter.
Notice achy muscle at sight of flu shot right upper arm for more than a week, shingles observed above flu shot, spreading up back of neck, around to front chest and up throat into lymph node in throat and on right side of head.
PATIENT STATES THAT SHE HAD RED DOTS ON HER LEGS. HER DOCTOR SAID ITS BLEEDING UNDER THE SKIN/BRUISING, AN ALLERGIC REACTION TO THE VACCINE.
I received the Covid-19 vaccine on 1/4/22. I have had severe soreness at the infection site since I got the injection. On Thursday evening 1/13/22 a firm quarter sized red nodule appeared on my left upper arm that was hot to touch. Over the next couple of days the spot has spread out with sever redness, itching, and dull pain. Hard to sleep on that arm without severe soreness and very hot to touch. As of 1/17/22 this area is still present and spreading in size.
This spontaneous prospective pregnancy report was received from the patient's mother and refers to a 20 year old female patient with no drug reactions or allergies. The patient's concurrent conditions included high cholesterol and fatigue. The patient was also a mononucleosis carrier. On approximately 13-AUG-2015, the patient became pregnant with LMP (last menstrual period) of 30-JUL-2015 and EDD (estimated date of delivery) of 05-MAY-2016. At the time of the report on 25-FEB-2016, the patient was 30 weeks pregnant. The pregnancy outcome was pending. On 11-FEB-2016 (reported as "2 weeks ago"), the patient had visited her physician for her 28-week examination. The physician advised the patient, that she should take a "whooping cough vaccine". On an unknown date in February 2016, the patient was erroneously vaccinated with a dose of GARDASIL 9 (lot # was not provided) first injection, 0.5 ml, intramuscularly for prophylaxis instead of receiving a "whooping cough vaccine". Concomitant therapies included prenatal vitamins. The patient sought medical attention and was given an ultrasound to check progress of the baby in uterus (results were not provided). Since an unknown date in February 2016 (reported as "since that time"), the patient seemed more fatigued than normal and noted that the baby had "flipped" and felt less active (captured in MARRS # 1603USA001784). The outcome of the event of fatigue was unknown. The relatedness between the events and GARDASIL 9 was not reported. This is one of two reports received from the same source. Additional information has been requested.
Severe headache, nausea and vomiting, chills started at 11:00 am the next day and those symptoms lasted 1 additional day. 3rd day general malaise, nausea, and fatigue.
30 minutes p/MMR inject, pt broke out in a fine generalized rash all over body; pt was sent to MD;
Started with tingly fingers 20 minutes after shot that then become Numb fingers, then left side of my face started to tingle then became numb! Half my face half my nose was numb. Started 25 minutes after shot. Then by night time my left arm became paralyzed! Couldn?t move arm & fingers were numb. Next morning I could move arm from elbow down- fingers started getting feeling back. Face got feeling back but my half of nose stsyed numb another day. Then got a migraine that lasted a full week!
left tongue deviation; right radial numbness in the right arm/ left facial numbness/ numbness in feet; left facial tremors; weakness in legs; This is a spontaneous report from a contactable physician's assistant in Emergency Medicine. This physician's assistant reported similar events for three patients. This is the second of three reports.  A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after receiving the vaccine, the patient experienced right radial numbness in the right arm, left facial numbness and left facial tremors, left tongue deviation, numbness in feet, and weakness in legs. The clinical outcomes of the right radial numbness in the right arm, left facial numbness and left facial tremors, left tongue deviation, numbness in feet, and weakness in legs were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.          Amendment: This follow-up report is being submitted to amend previously reported information: to correct the patient initials and patient information.  Follow-up (01Apr2021): New information received from the same physician's assistant includes: reporter occupation updated.   Follow-up (05Apr2021): This is a follow-up report to notify that the case 2021276385 and case 2021372512 are duplicates.  All subsequent follow-up information will be reported under manufacturer report number 2021372512.; Sender's Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported event left tongue deviation cannot be excluded, due to a plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-2021154431 same reporter, product, and event; different patient; PFIZER INC-2021372580 same reporter, product, and event; different patient
This case reported by a pharmacist and described the occurrence of inappropriate age at vaccine administration in a 17-year-old female patient who received HAVRIX ADULT (batch number GX2LA, expiry date 7th June 2015). On an unknown date, the patient received HAVRIX ADULT. On an unknown date, an unknown time after receiving HAVRIX ADULT, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: An adult dose of HAVRIX was written by an MD and administered to a 17 YO patient. This error was identified when the patient returned for their booster dose of HAVRIX.
Hypercarbia, increased work of breathing, retractions, increased oxygen needs, and ventilatory needs, agitation.
Information was received from a chief researcher through an online article via a company representative referring to 44 female patients of unknown age. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with GARDASIL (lot#, expiration date, dose and route were unknown). On unknown dates, the patients died of this vaccine. The cause of death was unknown. It was unknown if autopsy was performed. The reporter considered death to be related to GARDASIL. Upon internal review, death was determined to be a medically significant event. This is one of several reports received from the same reporter. Additional information is not expected.
her hips and back hurt a little bit; felt run down; her hips and back hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (her hips and back hurt a little bit), FEELING ABNORMAL (felt run down) and ARTHRALGIA (her hips and back hurt a little bit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (her hips and back hurt a little bit), FEELING ABNORMAL (felt run down) and ARTHRALGIA (her hips and back hurt a little bit). At the time of the report, BACK PAIN (her hips and back hurt a little bit), FEELING ABNORMAL (felt run down) and ARTHRALGIA (her hips and back hurt a little bit) outcome was unknown.            No Concomitant medications were provided No Treatment information provided     This case was linked to MOD21-065465, MOD-2021-065604 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-065465:cross link MOD-2021-065604:Crosslinked
12/23/21  Office Visit     tested positive home test 12/21/2021 o Cough o Sore Throat o Nasal Congestion o Fever o Covid-19 Positive complains of URI Sx onset  3 days ago Fever  positive  Chills negative Cough positive  Sputum production positive   Sinus pain negative Headache  positive  Shortness of air  positive  Sore throat positive Hx Asthma negative Hx pneumonia negative meds tried  OTC cough syrup ibuprofen reports that he quit smoking about 2 years ago. He started smoking about 17 years ago. He smoked 0.70 packs per day. He has quit using smokeless tobacco.     Review of Systems  Constitutional: Positive for chills, fatigue and fever. Negative for diaphoresis.  HENT: Positive for congestion and sore throat. 12/23/21  Review of Systems  CHENT: Positive for congestion and sore throat. Negative for ear discharge, ear pain, hearing loss, nosebleeds and tinnitus.   Respiratory: Positive for cough and shortness of breath. Negative for wheezing and stridor.   Cardiovascular: Negative.   Musculoskeletal: Positive for myalgias.  Skin: Negative.   Neurological: Negative for weakness and headaches.
Gave both vaccines, 1 minute after giving vaccines patient turned pale and expressed feeling dizzy. Immediately had patient lie down. Monitoring patient in exam room, he expressed starting to feel better after 10 minutes. Had him slowly sit up but lost color and felt dizzy again so had him lie down again. Nurse come in to exam room to assess patient came in and again offered water and ice pack. Patient did take water but again declined ice pack. Stayed another 5 minutes and then color returned to patient's face and he no longer felt dizzy. Walked out of office on his own. Mom aware to call office if any further reactions or concerns. Made Provider Dr. aware.
Patient developed left leg and calf pain 2 weeks after vaccination. He was found to have thrombosis of the deep veins of the left calf. He has no risk factors for clotting and has not had any recent prolonged immobilization.