chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office manager refers to a current 22 year old female patient. The patient's current conditions or medical history were not reported. On an unspecified date in 2009, the patient received the first dose, on an unspecified date in 2012, received the second dose and on 31-MAR-2014 the third dose of GARDASIL injection (dose, route, lot number and expiration date not reported). No adverse effects had been observed or reported. The patient received the third dose of GARDASIL under the supervision of the physician, but the first two doses were administered at another healthcare professional's facility. The specific dates of the first two doses of GARDASIL were not available at the time of the report. Additional information has been requested.
Information was received from a health care professional on 30 October 2009 and 02 November 2009 which consisted of a cluster of 14 identifiable patients who experienced adverse events after receiving H1N1. This serious case represents one patient out of the cluster of 14 patients. A male patient (age and date of birth not reported) had received an injection of H1N1 (route and site of administration not reported), lot number UP006AA on 30 October 2009 and one hour later he experienced dizziness, headache, sore throat, trouble swallowing (also reported as throat closing) and stated he felt hot. He was administered BENADRYL and taken to the emergency room. The patient was in stable condition when he left the facility he was vaccinated at to go to the emergency room. Outcome was reported as unknown. No additional information was provided at the time of the report. The reporter for this case is the same as for case numbers 2009-04660, -04661, -04662, -04663, -04664, -04665, -04666, -04668, -04669, -04670, -04671, -04672 and -04673. Documents held by sender: None.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # M017983 with expiration date: 30-MAY-2018 for prophylaxis. Temperature/time frame: 1 C for 11 hours, 11 minutes. Prior excursion: 1 C for 16 hours. Data logger was involved. No adverse effects reported. No product quality complaint was involved. No additional information was provided. Additional information has been requested.
Pt received Proquad(MMRV) and Pediatric Pfizer Bivalent. Pt was due to receive DTAP, PCV, and Infant Pfizer Bivalent.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000862: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-0095075131907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
Rash in the entire arm where the injection was given; Itching/Also had itching on legs; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 13:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient previously took ibuprofen(MOTRIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced itching and rash in the entire arm where the injection was given. This lasted 5 days, very itchy, itching on legs but no rash there. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event rash was recovered on an unknown date in 2021 and the clinical outcome of the event itching was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Swelling on two fingers on her right hand; Itching; Red spots; A spontaneous report was received from a consumer concerning a 68-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling on two fingers on her right hand / peripheral swelling, red spots / erythema and itching / pruritus.  The patient's medical history and concomitant product use was not provided by the reporter.  On 15 Feb 2021, approximately one day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, patient experienced the events, swelling on two fingers on her right hand, red spots and itching.  Treatment for the events included naproxen and cortisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, swelling on two fingers on her right hand, red spots and itching was unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received shingles and still got the shingles.  The patient stated that like all vaccines just because you got it does not mean you won't get it. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
High pitched hissing, ringing sound in ears. Headache.  No treatment other than Ibuprofen for headache.  Both symptoms are continuing, and have not stopped.
Not feeling good (malaise); Fever; Headache; Nausea; Feeling lightheaded over the weekend; Remaining in bed; Soreness under armpit; Stomach started to bother a little / and it feels dull; Stomach hurts a little; Soreness at the injection site/Pain in arm; Arm felt heavy lifting up; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019 06:30, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain and heaviness in arm. On 14th September 2019, the patient experienced malaise, fever, headache, nausea, light headedness, bedridden, axillary pain, upset stomach and stomach pain. The patient was treated with paracetamol (Tylenol) and non-drug therapy, non-drug therapy (Ice Pack (No Medication)). On 15th September 2019, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the injection site pain, heaviness in arm, malaise, fever, bedridden, axillary pain, upset stomach and stomach pain were unknown and the outcome of the nausea was not recovered/not resolved and the outcome of the light headedness was recovered/resolved.   It was unknown if the reporter considered the injection site pain, heaviness in arm, malaise, fever, headache, nausea, light headedness, bedridden, axillary pain, upset stomach and stomach pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and approximately 6:30 pm in her left arm and immediately had soreness at the injection site.  The caller reports her arm felt heavy lifting up. The following day the patient waking up in morning and soreness in her arm, not feeling good (malaise), having a fever of 100 F, onset of headache that was relieved Sunday, nausea that lasted throughout the day, remaining in bed throughout the weekend, feeling lightheaded over the weekend, and soreness under armpit.  The caller at the time of reporting soreness now extending down her arm and approximately half an hour prior to contacting GSK she began to feel nauseous again.  The caller reported when this nausea came her stomach started to bother her a little.  The caller reported her stomach hurts a little and it feels dull but not a feeling of needing to go to bathroom. The reporter consented to follow up.  This case linked with US2019AMR169698, reported by same reporter.
General aches and pains that also aggravated my prostate, causing urgency, pain upon urinating. All symptoms abated after 24 hours.
Pt received DTAP + Proquad on 9-16-2020. Started with swelling and redness of Right knee + Thigh that evening. Pain with standing. Subjective Fever. Pain, Swelling and redness increased by Day 2 after vaccine. Significant Swelling of (R) knee but right thigh Felt tight. would not bear weight. No redness or swelling noted @ injection site. Seen by Provider on 9/18/2020. Advised to elevate Leg, and us heat over the week end. To F/U in office in 2days (Monday). I spoke with mom today 9/21/20. She said the swelling, redness and pain were gong by the morning of 9-19-20. Pt running around and No problems noted. 0 Fever
Narrative:  Patient visited the ER on 5/4/22 where physician stated that swelling of the injection site looked abnormal. There was a working diagnosis of possible cellulitis. After initiating cephalexin, the patient's arm greatly improved after 2 days. Unable to determine if cephalexin administration correlated with improvement in symptoms.
Sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site left arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B2A) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction. Concomitant products included IBUPROFEN from 19-Apr-2021 to an unknown date for Tooth extraction.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site left arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
6 days later- low back pain, strange headaches, rash of blisters on my left face from the lower lips to my nose. My lips are completely dried out and raw like all the skin is peeling. Severe fatigue.
Hospitalization: admitted 8/17/2022; discharged 8/24/2022.  Presentation to the ED: weakness, malaise, nausea, vomiting, diarrhea, hypotensive. Patient had black stools.  COVID-19 + date: 8/24/2022 Treatment: patient was treated for acute GI bleeding. COVID prophalyxis was not administered.  Discharge to: SNF
Pt reports neck pain and HA upon waking 6/15. "When I move my head forward or down it feels like its about to fall out." Later reports feeling dizzy when walking around but has seen a little improvement. Told pt to seek care at EMR if no improvement or gets worse.(approx. 10am 6/15/19)
Turned bright red; Had a little tingling in their nerves; 4 nose bleeds; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Turned bright red), PARAESTHESIA (Had a little tingling in their nerves) and EPISTAXIS (4 nose bleeds) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced ERYTHEMA (Turned bright red), PARAESTHESIA (Had a little tingling in their nerves) and EPISTAXIS (4 nose bleeds). At the time of the report, ERYTHEMA (Turned bright red) and PARAESTHESIA (Had a little tingling in their nerves) outcome was unknown and EPISTAXIS (4 nose bleeds) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not Provided by the reporter. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-099813 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: New AE Added
Within a few hours the right arm became extremely sore.  By the end of the day I could barely lift the arm.  That night I had trouble sleeping due to the pain in the arm.   Next day - continued right arm pain- severe, headache Day two - chest discomfort- pounding, pressure , headache Day Three- slight labored breathing arm began to feel better and less pain in the arm, headaches The week of the shot- continued chest discomfort/ pressure, ringing ears and pain in ear, headaches, arm pain better.  Called Hospital and they stated no need to be concerned and that the issues would go away. Following week- headaches, ear pain, one cold sore on lip, chest discomfort and cough developed called Hospital and informed of the issues.  On 7-29-2021 at 4:30 pm received second shot as planned based on Hospital Advise- No new side effects  As of August 31, 2021 I have intermittent ear pain and severe cough that will not go away.  Chest pain has been intermittent and no arm pain.  Sore is gone.  Headaches are better but intermittent.
Sudden hearing loss and tinnitus.  Oral steroid within week of onset.  No change. First Intratympanic steroid injection within 30 days of onset (October 1, 2021).  No change. Second Intratympanic steroid injection within 40 days of onset (October 7, 2021). No change.
Information has been received from a certified medical assistant concerning an 8-year-old female with no pertinent medical history or allergies who in December 2000, was vaccinated subcutaneous with 0.5 ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 02-SEP-2007 the patient developed varicella and has about 10-15 lesions. The patient sought medical attention via an office visit. No diagnostic labs were performed. At the time of the report the patient was recovering. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
some soreness at the right deltoid injection sight; 15 year patient was given Flublok vaccine in error; Initial information received on 07-Oct-2019 and follow-up information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 years old patient who experienced some soreness at the right deltoid injection sight (Vaccination site pain) while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE Prefilled syringe (lot number: QSAA1921 and Exp date: 30-Jun-2020) via intramuscular route in the right deltoid.  On an unknown date, patient developed a non-serious soreness at the right deltoid injection sight (vaccination site pain) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. The nurse states that, the soreness is not abnormal.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  (Other relevant tests included No lab data.)  Final diagnosis was vaccination site pain.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for vaccination site pain.  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
Patient had an abnormal mammogram believed to be related to vaccination.  On ultrasound follow-up, lymph system was described as swollen to patient.  She will require a repeat mammogram 6 months after completion of vaccination series. Patient also complains of a rash which is mild and improving as of 3/17.
Patient began itching 10 minutes after receiving the vaccine. Her neck, arms, and legs were the most severe in itching. She was not having any other symptoms. No SOB, no tongue/throat tingling or swelling, no arrhythmias, no change in baseline blood pressure, she was non-diaphoretic, no nausea/vomiting/diarrhea. She was just itching. I checked her vitals and her blood pressure was 178/91 and heart rate was 94. She indicated prior to checking her blood pressure that her baseline was typically in the 170s systolic and 90s diastolic. She is on management medication for this. I notified our provider at our clinic of her reaction and was given a verbal order to administer Benadryl that we have on standby for an event such as this. At 12:10pm I gave her 100mg of Benadryl intramuscularly in her left deltoid (Covid injection went in her right.) Her itching slowly started to ease off. By 12:40 her itching was only localized to her neck, which was where it was the most severe. The employee walked back to her office at 12:50. I called to check on her at 1:00 and she said that she was only itching slightly still on her neck. I called her extension again at 2:30 to check on her and she indicated that she was not itching anymore what so ever.
She couldn't sleep all night.; Same day after receiving 2nd dose, she started having pain in whole body; She also started with headache; fever; chills; it is way too much pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (it is way too much pain), INSOMNIA (She couldn't sleep all night.), MYALGIA (Same day after receiving 2nd dose, she started having pain in whole body), HEADACHE (She also started with headache) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (it is way too much pain). On 19-May-2021, the patient experienced INSOMNIA (She couldn't sleep all night.), MYALGIA (Same day after receiving 2nd dose, she started having pain in whole body), HEADACHE (She also started with headache), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (it is way too much pain), INSOMNIA (She couldn't sleep all night.), MYALGIA (Same day after receiving 2nd dose, she started having pain in whole body), HEADACHE (She also started with headache), PYREXIA (fever) and CHILLS (chills) had not resolved.
Patient fainted almost immediately after needle was withdrawn and bandage was applied. Patient reports always fainting with any shot he gets. Was out for about 3-5 seconds, then came to, and no other issues afterwards.
Patient developed a migraine headache, nausea, dizziness, and sensitivity to light and sound, unexpectedly, about an hour and 35 minutes after receiving a mandatory flu shot at his workplace. Patient was unable to drive himself home. Symptoms lasted about 4 hours. Please end mandatory vaccinations.
12:20pm:  Intermittent cough onset and throat itchiness.  Pt. refused Epipen and stated that she had Benadryl in her purse and would take it "if she needs to."   12:38pm:  Decreased throat itchiness and cough.   12:55pm:  Client stated that "I am feeling much better now."