chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was received expired dose of MENACTRA, no AE; Initial information received on 01-Feb-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (unknown demographics) who was vaccinated with an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   Patient did not received other vaccines.  On 01-Feb-2021, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AA and expiry date: 26-Jan-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  At the time of report, no adverse event was reported.  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.
His arm also hurt; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His arm also hurt) and HEADACHE (Slight headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 004M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (His arm also hurt) and HEADACHE (Slight headache). At the time of the report, PAIN IN EXTREMITY (His arm also hurt) and HEADACHE (Slight headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Protein S: 1732 (High) Antibody test showed an S-protein count of 1732. On 18-Nov-2021, Protein S: 142 (Low) S-protein count of 142.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient did not take any treatments   This case was linked to MOD-2021-396060, MOD-2021-396043 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Nov-2021: Non Significant follow-up appended
Loss of consciousness multiple times, swelling of throat, treated with Benadryl, fruit juice, and monitoring vital signs.  All occurred within 2 hours of shot administered
This medically confirmed spontaneous report (initial receipt: 21-Nov-2012) concerns a 69-year-old male patient. Concomitant medications included omeprazole, ramipril, metoprolol, potassium chloride, isosorbide mononitrate, doxycycline. On 09-Nov-2012 the patient received AFLURIA (batch number: 06549221A) injection at a dose of 0.5 mL intramuscularly. On 20-Nov-2012, 12 days after vaccination, the patient was admitted to hospital for kidney failure. He was currently on dialysis.
Arm slightly sore at injection site. Right arm, right shoulder, upper back, neck, left shoulder, left arm all extremely stiff sore and weak. Fatigue. Slight headache. Chest feels weak when breathing but not sure if it's due to upper body muscle weakness.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 22-OCT-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, albumin status HSA, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports from the same reporter. Additional information is not expected as no further follow-up is required.
Information has been received from a physician concerning a healthy 10 yr old white male who on 17Jun98 at 9:30 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot 624724/1327E). There was no concomitant medication and there was no illness at the time of vaccination. On 02Apr05, the pt experienced break through chickenpox. It was not a mild case but a full blown case of chickenpox. A product quality complaint was not involved. Follow up information was received from the physician who reported that on 02Apr05, the pt broke out with a full blown pox rash with greater than 50 lesions and a fever for a couple days. No diagnostic lab tests were performed. Subsequently, on an unspecified date, the pt recovered. There were no adverse events following prior vaccination. No further information is expected.
Initial and follow up information has been received regarding a case in litigation concerning a male child who, for the first two years of his life was vaccinated with injections containing the dangerous and highly toxic mercury based preservative thimerosal. The alleged result of these vaccinations is that the patient now suffers from, and allegedly in the future will continue to suffer from, the toxic neurological effects of mercury poisoning. Immunization information indicated that the patient was vaccinated with hepatitis B vaccine recombinant on 6/2/98, 7/3/98, and 12/8/98. Concomitant therapy included haemophilus B conjugate vaccine on 7/29/98, 10/01/98, 12/8/98 and 12/7/99, poliovirus vaccine on 7/29/98, 10/1/98, and 12/7/99, MMR vaccine on 9/2/99; alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid on 7/3/98, 10/1/98, 12/8/98 and 12/7/99; and varicella virus vaccine live on 9/2/99. This is a consolidation of two reports concerning the same patient. Upon internal review toxic neurological effect and mercury poisoning were determined to be other important medical events. No further information is available.  Reported on 05/14/2003: "Additional information received states the dates of injections of vaccines containing thimerosal include 06/02/1998, 07/03/1998, 07/29/1998, 10/01/1998, 12/08/1998, 09/02/1999, and 12/07/1999.  Upon internal review toxic neurological effect and mercury poisoning were determined to be other important medical events (OMIC).  No further information is available.
This spontaneous report as received from medical assistant via a physician refers to a unspecified amount of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient were vaccinated with improperly stored RECOMBIVAX HB (lot M037248, expiration date 21-FEB-2019; lot N006321, expiration date 08-NOV-2019)(incorrect product storage) for prophylaxis. Temperature was reported as 47°F to 77°F and Time frame was reported as 2 Hours 30 Minutes. Previous temperature excursion was involved. The call was because of a "data logger".  No adverse effects reported. No PQC involved. No further details provided. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1708USA006276: US-009507513-1708USA006277:
Narrative: COVID infection following COVID vaccine series 03/19, Pfizer, dose #1 04/09, Pfizer, dose #2 09/25 COVID swab, result: detected 09/25 pt cc: exposure: friend 09/25 SARS-COV-2 Variant Sequencing result: pending
Pussy sores and a rash on my arms and legs. Covid toes except it is my entire sole of my foot. My feet are red, swollen and feel tight and on fire. I felt better with massage and a hot shower but it is lingering.  Half of my body is rash like and the other is sores that have a small amount of puss in the center. Very itchy and on fire. After benedryl lotion the rash is just red raised and present.
Initial report was received from a company representative on 03 October 2011. A female patient (age and date of birth not reported) had received a FLUZONE Intradermal (lot number not reported). On an unspecified date, the patient experienced immediate swelling and couldn't sleep on her side during the night. The patient also developed dizziness and faintness which lasted for a few hours. No further informational was available at the time of the report. The patient outcome was not reported. Documents held by sender: none.
Dizziness. Pt became altered. Evaluated by EMS-Refusal to transport.
Date and time adverse event started: 3-26-21 0900 lump in right axillary area, HA, angio
Pt recvd 2 doses of Engerix-B & 7 hrs p/2nd dose devel cramping, nausea, sweating, fatigue, diarrhea & was lightheaded; arms felt heavy & were swollen w/red blotches the diameter of a dime; since devel hives on forearms & legs;
Sore arm lasting 8 weeks so far.  Second shot in same arm added to the pain.
severe shaking; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (severe shaking), CHILLS (chills) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (chills) and HEADACHE (Headache). On 17-Feb-2021, the patient experienced TREMOR (severe shaking). At the time of the report, TREMOR (severe shaking), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included lorazepam, acetaminophen and dexamethasone.
pt recv vax 18SEP98 & c/o arm swelling, very tender, area reddened;stated had a severe h/a lasting 2 days;3rd day h/a resolved arm less tender decreased ins welling no redness;APAP taken for h/a;ice applied to arm;
Vaccine expired 8/31/2022, yet given 9/1/2022.
Information as received from a certified medical assistant (C.M.A.) refers to 6 months old infant of an unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2015, the patient was vaccinated with a dose of oral, ROTATEQ lot # K023159, expiration date 26-JUL-2016 which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
temperature excursion; This spontaneous report was received from a 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 01-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter, 1 dose, subcutaneously, lot # T016990, expiration date 11-NOV-2021 (dose number and vaccination site were not provied) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of 9.9 degrees Fahrenheit for 2 hours and 11 minutes on 14-SEP-2021 and to the temperature excursion of 6.6 degrees Fahrenheit for 59 minutes on 15-SEP-2021. There was a previous temperature excursion, 7.3 degrees Fahrenheit for 37 minutes on 25-JUL-2021.
The vaccine reached temperature of 12C, duration of excursion was 31-33 hours and was adminsitered to the patient; The vaccine reached temperature of 12C, duration of excursion was 31-33 hours and was adminsitered to the patient; This spontaneous case was received on 02-Mar-2021 from pharmacist (reference number: SEQW21-00866) with additional information received on 03-Mar-2021 and 04-Mar-2021 (being processed together) and concerned an adult male patient of an unspecified age.  The patient's medical history and concomitant medications were not reported.  On an unknown date, Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent) had temperature excursion that reached 12 degree Celsius (C) for 31 to 33 hours (explicitly coded as 'Product storage error temperature too high'). The batch number reported was 281835 and expiry date was 30-Jun-2021.  On an unspecified date, after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent (dose, route of administration, indication and anatomical location: not reported) (explicitly coded as 'Product administration error').  At the time of initial reporting on 02-Mar-2021, it was not reported if the patient had any adverse events after Flucelvax Quadrivalent administration.  Company comment: On an unknown date, Flucelvax Quadrivalent had temperature excursion that reached 12 degree Celsius for 31 to 33 hours. On an unspecified date, after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent. It was unknown if the patient experienced any adverse event after Flucelvax Quadrivalent administration. Product storage error and product administration error are assessed as unrelated per company's conventions.; Sender's Comments: On an unknown date, Flucelvax Quadrivalent had temperature excursion that reached 12 degree Celsius for 31 to 33 hours. On an unspecified date, after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent. It was unknown if the patient experienced any adverse event after Flucelvax Quadrivalent administration. Product storage error and product administration error are assessed as unrelated per company's conventions.
Case number PHEH2014US025043, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 65-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 12 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
ADMINISTRATION OF VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITION; TEMPERATURE EXCURSION BETWEEN 46.04 TO 49 DEGREES FOR 24 HOURS AND THEN PUT IN REFRIGERATOR; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) dose was not reported, administered on 15-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-NOV-2021, the patient experienced administration of vaccine stored outside of the recommended storage condition, and temperature excursion between 46.04 to 49 degrees for 24 hours and then put in refrigerator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine stored outside of the recommended storage condition and temperature excursion between 46.04 to 49 degrees for 24 hours and then put in refrigerator was not reported. This report was non-serious. This case, from the same reporter is linked to 20211139494.
Patient developed pain (no redness) at injection site 2 days post administration. Patient stated his pain is 8/10 - but has taken no meds to alleviate pain, other than daily meds prescribed via pain management doctor. I encouraged Ibuprofen ATC/ice to decrease pain/inflammation and also told pt to follow up with doctor on Monday if pain still present. No redness, inflammation or knots noticed upon visual exam of arm.
Was really really dizzy hard to stand and sick to my stomach and a headache so bad none of my medicine would not even work
SORENESS OF ARM; MILD HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced soreness of arm. On APR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild headache and soreness of arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210430098.
Swelling, rash, bruising, pain arm pit and arm to elbow. Caused cysts arm pit area left arm. Second shot in right arm caused symptoms to get worse in left pit area and swelling of right pit area.
12pm Sleepy  3-4pm Nauseous Feeling, slight headache  4pm-5:30am Started with vomiting, then continued to intense projectile vomiting, constant severe migraine headache, stiff, sore neck, sharp chest pain when throwing up, pulled shoulder puking. Nausea waves when not throwing up, (12am blood pressure 179/111)  Sunday Sore stomach, dissipated headache, exhausted, constipated, sore arm, (blood pressure 134/84)  Monday Tired, less sore stomach, Sore arm, diarrhea (night)
Noted elevated temperature 12 hrs after injections. Fever peaked at 101.2 F at about 14 hrs after injection. Took Tylenol which lowered temperature to 100 F within an hour. Temperature returned to under 99 F within 48 hrs. I don't know the type of flu or shingles vaccine. The shingles injection was the first of two, with the second to be taken 2-6 months later.
Bruising on sides of legs and stomach.; Blisters on chest and arms / travelling down her legs; Reactions of hives on her chest / spread to her back, butt, and arms / spread to her face; This case was reported by a consumer and described the occurrence of hives in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included celecoxib (Celebrex) for product used for unknown indication.   On 23rd March 2021, the patient received the 1st dose of Shingrix (intramuscular) and Celebrex at an unknown dose and frequency. On 6th April 2021, 14 days after receiving Shingrix, the patient experienced hives (serious criteria clinically significant/intervention required). On 10th April 2021, the patient experienced blister (serious criteria clinically significant/intervention required). On 13th April 2021, the patient experienced bruising of leg (serious criteria clinically significant/intervention required). The patient was treated with cortisone (non-proprietary) (Cortisone Shot), prednisone and dermatologicals nos (Anti-Itch Cream (Medication Unknown)). The action taken with Celebrex was unknown. On an unknown date, the outcome of the hives, blister and bruising of leg were not recovered/not resolved.   It was unknown if the reporter considered the hives, blister and bruising of leg to be related to Shingrix.  Additional details were provided as follows:  The patient received Shingrix vaccine and experienced reactions of hives on her chest. On 10th April 2021, the patient had hives spread to her back, butt, arms, blisters on chest and arms, started traveling down her legs. Consumer went to an urgent care in (contact information unknown) and received a Cortisone shot and also visited local Urgent care. On 13th April 2021, the consumer returned to PCP with little improvement of adverse reactions, and now with bruising on sides of the legs and stomach.  PCP administered second Cortisone shot and as of today, has continues with little improvement of adverse reactions.
About 2 to 3 minutes after receiving the injection I felt light headed and passed out. My wife said my eyes were open but glazed over. I also started shaking. When I woke up I was confused and felt nauseated.  A few minutes after I woke up the EMTs ran my vitals. My heart rate was in the 40s and my blood pressure was in the 90s. I have never had a reaction like this to any other shot/vaccines.
After 24-48 hours post vaccine, patient complained of body itchy, swelling in joints and throat.  Patient took two benadryl per pharmacist and symptoms subsided.
Fainted. in addition to vomiting, severe sweating, headache, achy, fever, chills, etc.
Information has been received from a licensed practical nurse concerning a 70 year old white female with new onset diabetes mellitus and osteoporosis who on Sept 25 2004 was vaccinated intramuscularly with a first dose of pneumococcal 23v polysaccharide vaccine (lot 645255/1212M). On Sept 25 2004, the patient developed pain in shoulder near the injection site with swelling. The affected arm was sore, red and swollen. it was hard to raise the arm and to sleep on that side for about 3 days. The patient sought medical attention and was treated with ice, acetaminophen (Tylenol) and ibuprofen. The patient subsequently recovered. The nurse also reported 2 other patients who had similar symptoms post vaccination with pneumococcal 23v polysaccharide vaccine (lot 645255/1212M) ( Waes0411USA01576, WAES0411USA01577). No additional information is expected.
Pt got 2 shots around 11:15am. One for flu vaccine and one for pneumonia. By 2:00 or 3:00pm, pt felt listless and mentally dull. By 06:00pm, pt felt stiff in right arm and shoulder (site of shot). By 7:00pm, pt was in so much pain that she wept. This intense pain continued throughout the night. The next day, the pain in my armpit and rib cage had lessened, but still had intense pain near where she had the shots. Now about 4 days later, pt mental state has improved, but still have tenderness in my arm where she had the 2 shots to the extent that she cannot sleep on that side.