chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed explosive diarrhea and emesis shortly after vaccine given. On 2/6/07 he was admitted for worsening vomiting, and on the morning of 2/7/07 he was found to have intussusception.   3/1/07 Received medical records from hospital which reveal patient experienced dehydration, vomiting & diarrhea, tactile temp at home, cough & nasal congestion. Seen in ER x2 then admitted.  After admission, had large maroon stool & continued to have bile tinged emesis.  After confirmation of IS, patient transferred to higher level of care. 3/15/07 Received medical records from transfer hospital which reveal patient admitted 2/7/07-2/8/07 s/p 48 hour history of abdominal pain, diarrhea & 1 week history of flu like symptoms w/bloody stools developing 24 hours prior to admit.  IS successfully reduced w/air enema & kept overnight for observation.   FINAL DX: Intussusception, reduced by air contrast enema.
6" oblong area that is itchy and hot to touch. Pt. used ice and Benadryl.
Felt like throat was closing up, itchiness, self administered Benadryl. Refused transport by EMS.
Arm, shoulder and neck swelling. Body aches all over, unable to rest, low grade fever, headache and fatigue Took Aleve - little relief Benadryl- no relief
injection site whelp; This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 90-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   On 19th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th June 2019, immediately after receiving Shingrix, the patient experienced injection site wheal. On an unknown date, the outcome of the injection site wheal was not recovered/not resolved.   It was unknown if the reporter considered the injection site wheal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. The patient immediately developed a whelp the size of a gulf ball at the injection site. Reporter was unable to provide additional information.
one month old patient was administered Adacel in error today instead of the intended hepatitis with no adverse event, no AE; one month old patient was administered Adacel in error today instead of the intended hepatitis with no adverse event, no AE; Initial information received on 02-Mar-2021 regarding an unsolicited valid non-serious case from a physician. This case involves a 1 months old male patient who was given DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number U6817BA ad expiration date 18-sep-2022) in error instead of the intended HEPATITIS B VACCINE (lot number and expiration date not reported),via unknown route in the right vastus lateralis for prophylactic vaccination on 02-Mar-2021 (wrong product administered) (product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication(s) were given to the patient.   It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (same day latency).  It was also reported that registered nurse was calling about accidental administration of ADACEL. What information was available? How does Adacel compare to DTaP (diphtheria, pertussis, and tetanus)? also with a question that any information do the agency have about DTaP given to a child under the minimum age?   It was not reported that the patient experienced any adverse event.  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 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.
So much pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (So much pain in my arm) 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 PAIN IN EXTREMITY (So much pain in my arm). At the time of the report, PAIN IN EXTREMITY (So much pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment medication was reported
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022 at 2:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Feb-2022 at 2:17 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. It was reported that, vaccine was administered on 11-Feb-2022 at 14:17:30 Its 30 days expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022 No treatment information provided.   This case was linked to MOD-2022-542869 (Patient Link).
Headache, malaise, fever - onset within 12 hours of receiving Adacel injection
Sore arm/soreness and swelling for a day; Sore arm/soreness and swelling for a day; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team.   A female patient of unspecified age (Age: 66; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm/soreness and swelling for a day on an unspecified date. The  Caller says had that before with a shot. Soreness and swelling for a day.  The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Pain at the injection site; On 21-FEB-2023, this serious, initial non-interventional study safety report from Regulatory Authority was received from a consumer via Regulatory Authority and was received by Novavax on 21-FEB-2023.  An individual of an unspecified race, age, and sex was vaccinated with intramuscular Novavax Covid-19 Vaccine (Recombinant and Adjuvanted) 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual experienced pain at the injection site (PT: Vaccination site pain) (Serious: Hospitalization) and was hospitalized for an unknown number of nights.  At the time of reporting, the event outcome of Vaccination site pain was unknown.  Lot number was not provided in the report.; Sender's Comments: This individual of an unspecified age and sex experienced: Vaccination site pain after vaccination with Covid-19 Vaccine (Recombinant, Adjuvanted) 10 ug/mL. The event Vaccination site pain was reported as serious. Considering the current knowledge of the vaccine, the causal relationship between Covid-19 Vaccine (Recombinant and Adjuvanted) and Vaccination site pain was assessed as unknown.
On Feb 26th - approximately 45 minutes after vaccination and departing site, symptoms began.  Swelling tongue and throat.  Wheezing and difficulty swallowing.   Proceeded to  ER and  taken in at 2pm.   Treated at ER with IV of Benadryl, Famotidine, MethlyPredeniSolone, Medrol with little effect.  Then did Epipen at 2:40pm.  Observed and discharged from ER at 4:50pm .     On Feb 27th - skin hives, headache, nausea, chills and overall body pain.  Taking Benadryl.  Have Rx with 2 EPIPEN kit.
Developed severe RLQ pain within 48hrs of H1N1 mist. Admitted to hospital ER overnight for observation. ABD MRI was normal.
I had abdominal pain, chest pain. I went to my physician who ordered testing and I was treated with antibiotics.
Fever, malaise, erythema and induration of 6 x 4 cm at site of injection, reports hands and feet so painful could not walk or use fingers, nausea, dizziness.
On 8/14/21 my ears felt like pressure was building up inside the canal.  At 3:00 I exit my vehicle and while at home my left ear proceeded to get worse.  Within 3 hours I lost complete hearing in that ear.
HEMORRHAGIC CVA ON 10/7/22. TRANSFERRED TO LOCAL GENERAL HOSPITAL, THEN TO ALTERNATE MEDICAL CENTER, THEN TO HOSPICE.
Pt under 18 years of age administered Moderna COVID - 19 vaccine outside of EUA criteria
Vaccine 1 (4/10/21: 12:15 p.m.) - woke up the following morning with chills, slight fever and headache, feeling off.  2 days later I woke up around 7:00 a.m. and I couldn't focus or read with my left eye. This resolved by noon so I didn't think about this being a side-effect from the vaccine until my major side-effect after the 2nd Pfizer vaccine. Vaccine 2 (5/1/21: 9:15 a.m.) - Injection hurt/severe chills by 2:00 that afternoon/nauseous/severe headache.  Woke up the following day feeling a little better but vision in left eye was off again and lymph nodes in my left armpit were huge, starting to lose feeling in left arm/following day no feeling in arm or fingers - this loss of feeling in arm/fingers lasted for about a week. The lymph nodes decreased in swelling but remained quite large for 6 months.  I still feel like they have not fully returned to normal size and experience discomfort. A little after 2 weeks after the second Pfizer vaccine, I woke up to complete white-out in my left eye unable to read or focus or see anything but blurry white. Went to optometrist (2 times), dentist, ENT, called family doctor and finally got in to the retina specialist early-June 2021 where I was diagnosed with inflammation of the retina due to Covid-19 Pfizer vaccine.  Vision is still not back to normal but has gradually improved. The vision strength in that eye has decreased, night vision is terrible and still have tiny blinking twinkles in the peripheral vision occasionally. The left eye also becomes fatigued easily and I cannot read or work on the computer for extended periods of time without eye breaks. This has also affected me mentally and has caused anxiety due to the stress of dealing with all of these side-effects.
Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
(L) arm inflammation  9.5 by 10.5 cm, red raised area on LA Deltoid
Difficulty Swallowing that has resolved. Numbness and tingling to left arm, nausea and vomiting
Information has been received from a physician and a practice manager via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 mcg/0.5 ml, lot # L045117 and expiration date 06-OCT-2018 (administration route was not provided). No adverse effects were reported. The vaccine had two temperature excursions, both of 144 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius (C)) and for the other a lowest recorded temperature of 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Feeling sick; Fever of 102 degrees; Coughing; Aching; This is a spontaneous report from a Pfizer-sponsored program entitled Pfizer First Connect. A contactable consumer reported for his sister (health professional) that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took the COVID vaccine but she was feeling sick, had a fever of 102 degrees, she was coughing and aching from couple of days after having couple of days in Dec2020. The events outcome was unknown. The reporter mentioned if patient goes to the hospital or not, asked if they should go to the hospital and. The patient was wondering if that was normal.  The information on the batch number has been requested.
sore arm; administered a dose of Shingrix adjuvant-only; administered a dose of Shingrix adjuvant-only; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number H9LL4, expiry date 24th November 2023) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (first dose received on an unknown date and refer case ID US2022152220).   On 20th October 2022, the patient received the 2nd dose of Shingrix. On 20th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 21st October 2022, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022152220   Additional Information: GSK Receipt Date: 21-Oct-2022 Reporter's comment: The pharmacist stated yesterday evening, on 20 Oct 2022, the patient received a second dose of Shingrix adjuvant only. 1 day after vaccination, the patient reported a sore arm on the day of reporting. The patient stated she remembered having a sore arm after first dose, however received two vaccines that day and was not sure which vaccine caused the sore arm. The reporter consent to follow-up. Additional supportive information: The patient received a second dose of Shingrix adjuvant only, which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered.This case had been linked with, US2022152220, reported by same patient.; Sender's Comments:  US-GSK-US2022152220:Same reporter
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. Nurse practitioner reported that on an unknown date, an unspecified number of patients may have received ROTATEQ exposed to 55F for 2 months, which has been found to be an unsupported excursion using in-house stability data. Concomitant medications were not reported. No adverse symptoms reported. Additional information has been requested.
Headache, Myalgia, Diarrhea, chills, soreness at injection site Narrative:
febrile sz on 30SEP98 tonic clonic activity lasting 1-2min followed by a post ictal period of 15min;assoc sx of vomiting & diarrhea for 2 days preceding sz;
Within 15 min of shot, had metalic taste in mouth with dasal drainage.  Withing 48 hours (12-23-20) experienced bilateral tingling in hands, arms, shoulders, neck, chin, cheeks, nose, eyebrows, scalp.  Asprin did not help.  Lightheaded after eat or drink.  12-24-20 Called family physician about possible alergic reaction.  Purchased Benadryl which seemed to help.  Metal tast from nasal drainage continued.  No temp, no sore throat, no cough; o2 stats 98 from puls ox. 12-28-20 Dr. ordered blood work.  Benedryl gave brief relief but tingling and shaky hands always returned. By the 31st tingling mostly in face, every day.  Some episodes lasted 2 hours, always bilateral. 1-13-21 Neck xray done.
Per wife - patient had fever (did not take temp) x 12 hours starting a few hours after receiving the PNEUMOVAX shot. States on 11-18-15 Rt. arm was swollen from shoulder to elbow with redness and pain. States patient was very tired also. 11-19-15 - fever gone, swelling and redness of arm persist - but improving.
Death within 30 days: Admit 2/8/21-2/13/21 s/p fall with left hip fracture (repaired), severe debility with recurrent falls discharged to SNF. Not doing well postop at the SNF, brought to ED due to failed foley insertion with bright red blood upon arrival to ER febrile, hypotensive, tachycardic, severe sepsis. Gran negative bacteremia likely from chronic ascites, family decided on comfort care and he expired within hours of admission.
pt felt like upper lip is heavy. no c/o itching, no swollen lips noted. no SOB v/s  97%RA 19cpm, 70bpm 120/70 BP  pt. stable and snet home @4:45pm   no swelling of lips, no itching, pt. feeling of heaviness of upper lips subsides.   Patient stable sent home
The day after the injection, I noticed a 3 inch solid red raised welt that was very warm to the touch. After several days, the welt began to break up into individual bumps. This continued and became itchy and a little sensitive. By 7 days, my arm was back to normal.
Patient received 1st dose of covid vaccine and instantly felt dizzy.  Client's skin pale, patient eventually vomited.  Patient stated they were very anxious over their 1st dose.  Patient fully recovered.  Symptoms no longer present.
did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain;  chest was killing me and hurting and I was sobbing and it lasted about an hour and 15 minutes; Side of my neck hurt; My back hurt; It was just awful; Lethargic; I ended up vomiting for 2 days after the chest pain receded; slept for 16 hours; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients (husband and wife). This case refers to the wife with serious adverse events.  A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration was not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux. Concomitant medication included dexlansoprazole (DEXILANT) for acid reflux. Patient reported that she had terrible severe reaction on the 22Jan2021. They were vaccinated on the 18Jan2021 and on the night of the 22Jan2021, she had such crushing chest pain that she just collapsed. Her chest was killing her and hurting and she was sobbing and it lasted about an hour and 15 minutes. The side of her neck hurt and her back hurt. It was just awful. Patient reported that she have called everybody. She have called her doctor's assistant and she confused her. Patient reported that they just went in because they were 70 and 71 and got the vaccine but then she ended up vomiting for 2 days after the chest pain receded and they took baby aspirin and then she just vomited and vomited and slept for 16 hours. They were both very lethargic. She asked her what should she do. She does not know if this was a reaction to the vaccine or did she have a heart attack. No doctor will see her to give me an EKG. They say they are not seeing patients. The patient recovered from chest pain on an unspecified date; while outcome of the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115775 same reporter/drug, similar event, different patient.
Confirmed with caller no other AE occurred; an expired dose of VAQTA was administered today; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 09-DEC-2021, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated(VAQTA) 1 dose, lot # t013205, expiration date: 03-DEC-2021 (dose number, exact dose and route of administration were not reported) for prophylaxis (expired product administered). No other adverse event (AE) occurred (no adverse event). The administered dose did not have any temperature excursions prior to administration.
blood clots in my lungs; chest/back pains; chest/back pains; pain; This is a spontaneous report from a contactable consumer. This contactable consumer (Patient) reported via mail that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Patient received the first dose on unknown date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took morphine. I was in the hospital Friday through Sunday getting treatments for blood clots in my lungs. I started having chest/back pains four days after getting my second Covid vaccination shot. The shots were from Pfizer. I went from being a strong, healthy person to one that was racked with pain and put on morphine in just a matter of days. My primary doctor said that he was going to report my case. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Slight swell in face, lips, cheeks; feeling of tightness; redness in face;, some nasal drainage.  Similar to reaction to hot peppers.  Took 1 Benadryl tablet.  Symptoms subsided over 24-hour period.