chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to a 12 month old patient. Concurrent conditions, medical history and allergies were not reported. On 09-FEB-2015, the patient was vaccinated with a dose of VAQTA 25/0.5 (units not provided), (dose, frequency, route and anatomical location were not reported), (lot # reported as K015827, expiration date: 11-MAR-2016). Other suspect and concomitant therapies were not reported. The reporter stated that the patient received three needle sticks instead of one because the VAQTA unit plunger rod "shot out of the syringe" while she was attempting to administer the vaccine. The nurse placed the needle in the patient and she drew back the plunger rod with her thumb to check for blood return before the administering VAQTA injection. At that time, the plunger rod shot out of the syringe barrel. The nurse replaced the needle a second and a third time and the same event with the plunger happened again. Nurse did not want to stick the patient a fourth time so after the third try she placed the plunger rod that shot out back into the syringe and complete the injection. It was also reported that the patient did not miss a dose and also only receive one dose. Product quality complaint (PQC) was filled. Additional information has been requested.
Patient called on 11/28/12 to report she had a skin reaction to the PNEUMOVAX vaccine given to her on 11/23/12 - she developed swelling and a red hard knot at the injection site. Patient is currently on chemotherapy and immunosuppressants and believes the reaction was probably due to that. Angioedema and red hard knot at injection site.
Vaccine injury at injection: Annual influenza vaccine, preservative-free by request (I don't know which type, brand name, etc.). I entered the clinic in the afternoon (I recall following work, around 3:00pm). Nurse introduced herself to me as the nurse "in charge" of (the vaccination administration/clinic). She checked to make sure it was ok with them for me to have the flu shot soon after my allergy desensitization injection. Nurse had me stand up as she gave me the injection very high up on my shoulder. I flinched and cried out a bit as the needle jabbed my shoulder inside. It was excruciatingly painful inside especially toward the front of my shoulder, and the pain branched out.
Loss of hearing in his right ear; A spontaneous report was received from a 73-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hearing loss in right ear.    The patient's medical history, as provided by the reporter, included ventriculoperitoneal (VP) shunt in his head. Concomitant product use was not provided by the reporter.   On 12 Jan 2021, approximately two days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the patient had dental work done where four crowns were prepped and temporaries were put in, he then lost hearing in his right ear. Treatment information was not provided. He thinks that the loss of hearing might be due to this dental procedure as they were drilling for hours. He states that he has a VP shunt in this head which needs readjustments occasionally. He is seeing his neurosurgeon for the readjustment.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, hearing loss in right ear, was unknown.; Reporter's Comments: This case concerns a 73 year-old, male patient with history of ventriculoperitoneal (VP) shunt in his head, who experienced event of hearing loss in right ear. The event occurred 2 days after the first and last dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.  However, on the same day and prior to the onset of the event, the patient had extensive dental procedures done which may provide an alternative explanation for the event.
Armpit nerve pain, muscle aches, headaches, dizziness since getting the Pzfizer booster vaccine. (Previously got the first 2 doses in May-June 2021).
1005 EMT noticed that patient was feeling dizzy.  Blood pressure 150/134. Patient stated"feeling light headed nauseated and headache" 1010am patient condition unchanged.   BP 127/96 HR 103. Blood pressure increased to 141/93. Patient symptoms started to worsen complaining of " pressure in my head, nauseated, muscle spasms" Epipen used at this time. Patient transported by husband to follow up with primary/urgent care
Skin sensitivity going up her rib cage; Nerves are on edge; Painful to touch and painful when she moves the wrong way; Site of injection issues of sore arm; flu-like symptoms; Site of injection issues of sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 2nd September 2020, the patient received Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). On 2nd September 2020, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the patient experienced injection site pain, sensitive skin, nervous and tenderness. On 3rd September 2020, the outcome of the pain in arm and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the sensitive skin, nervous and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injection site pain, influenza-like symptoms, sensitive skin, nervous and tenderness to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had site of injection issues of sore arm for 1 day.  Flu-like symptoms for 24 hours. Those aforementioned effects have resolved.  The following had not resolved. She has skin sensitivity going up her rib cage; it goes to the center of her torso and wraps around.  Her nerves were on edge. She painful to touch and painful when she moves the wrong way. Caller got Shingrix and flu shot at the same time.  The reporter did not consent to follow up.
18APR93 crying, swelling, pain, redness, 19APR93 vomiting, irritability inc as did swelling, consulted MD; 21APR93 prescribed Advil because of inc swelling & redness;
Brother also had less pain after receiving this vaccine.; Brother also had euphoric feeling with less pain after receiving this vaccine.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Brother also had less pain after receiving this vaccine.) and EUPHORIC MOOD (Brother also had euphoric feeling with less pain after receiving this vaccine.) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Brother also had less pain after receiving this vaccine.) and EUPHORIC MOOD (Brother also had euphoric feeling with less pain after receiving this vaccine.). At the time of the report, PAIN (Brother also had less pain after receiving this vaccine.) and EUPHORIC MOOD (Brother also had euphoric feeling with less pain after receiving this vaccine.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.    Reporter did not allow further contact
Patient received COVID 19 vaccine Pfizer 2/26 and 3/19/21. Patient was admitted on 4/25/21 with CC of fever, cough and shortness of breath for 2 days. No known exposure to COVID in last 2 weeks. Tested positive for COVID on 4/8/21 and 4/25/21. Admitted for RLL pneumonia.
injection site was red; injection site / very hot to the touch; This case was reported by a consumer and described the occurrence of injection site erythema in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and analgesic, nos (Analgesics). On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix and last night the patient's injection site was red and very hot to the touch. The patient used an ice pack for comfort.
Large 2 1/2 inch x 5 in Red/swollen/painful on left arm where injection given. Symptoms started Friday - getting worse - informed patient to call physician. Left arm only.
Laryngitis.; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP).  An adult female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) (Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported LARYNGITIS (non-serious), outcome not recovered.  It was reported that the patient believed she had been vaccinated but did not know which one or when.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
PATIENT CAME FOR HER FIRST DOSE OF COVID-19 VACCINATION. SHE WAS VACCINATED AT 9:30AM AND OBSERVED FOR 15 MINUTES. PATIENT HAD NO SIDE EFFECTS WHILE SHE SAT FOR 15 MINUTES AFTER BEING VACCINATED. SHE LEFT THE VACCINATION CLINIC WITH HER DAUGHTER IN LAW.  AROUND 10:15AM, THE DAUGTHER IN LAW CAME TO THE PHARMACY AND STATED THE PATIENT WAS HAVING A HARD TIME BREATHING IN THE CAR. ONE PHARMACIST RAN OUT TO THE PATIENT AND CHECKED HER PULSE. PATIENT WAS GIVEN A BENADRYL 25MG TABLET TO TAKE. PATIENT ALSO HAD NITROGLYCERIN TABLETS WITH HER AND TOOK ONE TABLET WHILE THEY WAITED FOR PARAMEDICS TO ARRIVE. I CALLED THE PATIENT AROUND 6PM THAT EVENING AND SHE STATED SHE WAS HOME AND FEELING BETTER. SHE WAS A LITTLE TIRED BUT WAS FEELING BETTER AND HAD NO OTHER SYMPTOMS.
This spontaneous report as received from a nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 30-MAR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB)(dose, frequency and route were not reported) (lot # N034005, expiry date: 31-JAN-2020) for prophylaxis. No adverse effect reported. No product quality complaint involved. The LIQUID PEDVAXHIB was stored in temperature of 32 degree Fahrenheit (F) to 35 F (32 F) for 8 minutes. No previous temperature excursion was reported. A digital data logger was involved.
Chest pain; Shortness of breath; Full lymph nodes under her left arm; This is a spontaneous report received from a contactable Consumer or other non HCP for a Pfizer sponsored program (159558). The reporter is the patient.  A 47-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Lot number: 3302680) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First vaccine: , Date: 01Nov2021, Lot: FH8020, Site: left arm), administration date: 01Nov2021, for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Chest pain"; DYSPNOEA (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Shortness of breath"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "not recovered", described as "Full lymph nodes under her left arm".
The vaccine given to the recipient was mixed with 2ml of the saline provided versus 1.8ml as instructed.   No adverse effects noted at time of vaccination.  Recipient has not called to report any adverse effect.  We have reached out on a daily basis and left msg on VM, no call back from recipient to date.
Chest pain where heart is, like a bad toothache...worse with exercise. Palpitations (weird heart beats) & shortness of breath.
Numbness and loss of dexterity in  my left arm. It started four days after second shot and still continues today. I have had  multiple doctors look at it and they cannot see a reason why there is this loss of function.
Pt vaccinated with Pneumovax 23 developed swelling at inject site, warm to the touch & painful, difficulty walking, fever of 100. Treated w/Acetaminophen (Tylenol) & warm packs.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 30-NOV-2015 at time- 06:41, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.8 and 1.9 (units unspecified) for 7 minutes respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a news source concerning a 14 year old female who on an unspecified date was vaccinated with GARDASIL.  The reporter indicated that the patient believed that she had an adverse effect after receiving GARDASIL.  The patient now suffers from chronic fatigue.  No further information is available.
DISCHARGE DIAGNOSES:   Hypoxic and hypercarbic respiratory failure due to COVID-19 pneumonia Acute metabolic encephalopathy due to the above Chronic hiatal hernia Chronic hypoxic respiratory failure Hypotension without shock Chronic hypertension Lactic acidosis Hypernatremia Leukocytosis Severe dementia, Alzheimer suspected Chronic hypothyroidism HOSPITAL COURSE:   The patient is a 96-year-old female with a history of severe dementia, chronically bedbound, minimally verbal at baseline, chronic hypoxic respiratory failure on 2 L at all times, history of DVT, chronic hypertension, hypothyroidism, heart failure, presenting to the hospital for altered mental status from care facility   In emergency department the patient was found to be tachypneic, hypercarbic, hypotensive.  Tested positive for COVID.  Family expressed a desire for the patient to receive BiPAP, fluids, steroids, and other interventions and intensive care team was consulted.  The patient continued on BiPAP for some portion of the following evening and was transitioned to facemask oxygen mask thereafter   Palliative care was consulted.  After further discussion with the patient's family it was elected that she would transition to comfort care only, with a desire that she complete a course of steroids.  She will discharge on hospice to her home with family to care for her.  Hospice consulted.   January 13: Yesterday the patient was placed on comfort care only, hospice consulted, palliative care arranged for discharge to home with home hospice cares.  Comfort cares only
After receiving the second shot of Moderna COVID-19 vaccine, I went through the normal feelings of fever, arm soreness, and headache, but that subsided after a couple days. After three weeks of receiving vaccine, my heart began to beat quickly and began to thump harder than after a heavy exercise. I was sitting down watching a lighthearted movie and would thump randomly with no anxiety, health issues, surprises, exercise, reason for it to beat rapidly. I had no health problems until I received the COVID-19 vaccine. It took approximately 8 months for the beating to subside after taking aspirin as a blood thinner, cutting down caffeine intake, and avoiding intensive cardio exercise in fears of a heart attack or stroke.   I am set to receive my first booster shot tomorrow. I am required to take it to attend school. If I die, of a cardiovascular illness, it will be because of this vaccine.
PT HAD NO PREVIOUS HISTORY OF INFLUENZA VACCINE. HE STATED THE HE "NEVER RECEIVED FLU SHOT BEFORE, EVER". IMMEDIATE ORAL SWELLING, SNEEZING, UNLABORED RESPIRATION, ALERT AND ORIENTED X 3. SEEN IN ER AND WAS DISCHARGED WITH PREDNISONE, CLARITIN AND BENADRYL.
Immediate feeling of mild drunkenness.      One day later better breathing.   Exhaustion gone
Per verbal report by guardian - pt developed hives approx 45 -60 min after vaccination of influ and dtap. Pt was given BENADRYL and hives began to disappear within 20 minutes of administration. Guardian advised to monitor for further reaction.
Almost immediately after receiving the vaccine pt went rigid and was unresponsive.  He came to within a minute.  He was very panicked and stated he thought it was a dream.  He was extremely pale and very sweaty.  We gave him some water and an ice pack to cool down.  We checked his blood pressure.  He then lied down on the floor and we elevated his feet.  He then stated he could not move his hands and his lips were tingly.  We then gave him some liquid benadryl and continued checking his blood pressure and called EMS.  They arrived and he left with them.  I tried contacting him later without success.  Will try again tomorrow.
hypertension (150/110) onset at 2am with tachycardia (138) that continued through the morning of the 25th into the next day. Tachycardia and hypertension improved the afternoon of the 27th.
Fridge door opened for long, 46.6F for 2 min due to human error with no reported adverse event; patient was given ipol after the temperature excursion with no reported adverse event; Initial information received on 31-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA235015, 2023SA235694, 2023SA235058, 2023SA236046, 2023SA234814, 2023SA235246.  This case involves a 16 years old male patient and temperature excursion for Poliomyelitis Vaccine (Inactivated) Ipv (Vero) (Ipol) fridge door opened for long, 46.6f for 2 min due to human error and patient was given vaccine after the temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, tetanus vaccine toxoid (tenivac) for prophylactic vaccination; hepatitis b vaccine (hepatitis b vaccine) for prophylactic vaccination; hpv vaccine (hpv vaccine) for prophylactic vaccination; hepatitis a vaccine (hepatitis a vaccine) for prophylactic vaccination; meningococcal vaccine b rfhbp/nada/nhba omv (bexsero) for prophylactic vaccination; and meningococcal vaccine a/c/y/w conj (crm197) (menveo) for prophylactic vaccination.  On 19-Jun-2023, the patient received Standard Dose 3 (0.5 ml) of suspect Poliomyelitis Vaccine (Inactivated) Suspension for injection (lot number: W1A191M; Expiry date: 16-Feb-2025, Frequency: once) via subcutaneous route in the right arm for prophylactic vaccination (Immunisation).  On an unknown date, the reporter reported temperature excursion for Poliomyelitis Vaccine (Inactivated) fridge door opened for long, 46.6f for 2 min due to human error with no reported adverse event (product storage error) (unknown latency) and on 19-Jun-2023, the patient was given Poliomyelitis Vaccine (Inactivated) after the temperature excursion with no reported adverse event (poor quality product administered) (Latency: same day).  It was reported, Fridge door opened for long *Max/Low temperature reached: 46.6F *Duration of temperature excursion: 2 minutes *Any previous excursions? None *Was it from a human error? Yes If negative advice, was the product administered to a patient? 7 doses of IPOL was given to 7 patients. HCP was asking if they need to re-vaccinate the patient given the opened IPOL after temperature excursion. This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  Action taken: not applicable.  Outcome: Unknown   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 the guidelines. 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.
It was kind of like overnight form Jan 4-5, I was very tired a low-grade fever in the morning and a runny nose, dry cough, and shortness of breath. It was really respiratory. and I was very lightheaded, and I started having sclerosis on the back of my hands neck and ears. I tested on the 01/05 and I reached out to another doctor when I started having sob. We spoke about steroids, but I started to recover so I didn't need it
Patient was given Moderna Bivalent instead of the Moderna Monovalent as the 2nd dose of the primary series.
pt devel warmth, swelling, pain @ the inject site w/in 7 days TD; pt's t99.7; pt had no other complaints; pt was monitored for development of a sterile abscess;
pt. received 2nd dose Moderna, came into observation area, sat in chair, had syncopal episode- fell out of chair hitting ground head first
Myositis; Pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOSITIS (Myositis) and PAIN (Pain) 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) 1 dosage form. On an unknown date, the patient experienced MYOSITIS (Myositis) and PAIN (Pain). At the time of the report, MYOSITIS (Myositis) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-426881, MOD-2021-426900, MOD-2021-426905 (Patient Link).