chrisvoncsefalvay/vaers-outcomes huggingface dataset:
knee was aching/stainless steel knee.; stainless steel knee; muscle aches; 29 year old patient received Shingrix; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st January 2020, the patient received the 1st dose of Shingrix. In January 2020, 1 week after receiving Shingrix, the patient experienced muscle pain and difficulty in standing. On 13th March 2020, the patient experienced knee pain and knee adhesion. On an unknown date, the outcome of the muscle pain, difficulty in standing, knee pain and knee adhesion were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, difficulty in standing, knee pain and knee adhesion to be related to Shingrix.  Additional details were provided as follows: About a week after receiving Shingrix, the patient experienced muscles aches severely.  If she sits down for a few minutes she cannot get back up because of the muscle pain.  It was severely constant during the first month.  Every day was different. On the day of reporting, 52 days after receiving Shingrix, her knee was aching and she had a stainless steel knee. The reporter consented to follow up.
Information has been received from a medical assistant referring to about 12 infants of unknown age and gender. The patients' had taken their bottle. The patient's, medical history and concomitant therapies were not reported. On an unknown date in 2017 (reported as over the last year), the patients were vaccinated with ROTATEQ (dose, frequency lot number and expiration date were not reported) orally for prophylaxis. On an unknown date in 2017 (reported as over the last year), the patients' would vomit up the entire contents of the ROTATEQ. The outcome of the event was not provided. The causality for the event was not reported.
5-month patient was given diluent portion of the Pentacel and not the vaccine/ NO AE; Initial information received on 11-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional via call-center.  This case involves a 5-months-old male patient who received only diluent portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] not the vaccine (frequency: once and strength: standard batch number: UJ226AAA and expiry date 04-Apr-2021) via an unknown route at an unknown administration site (product preparation issue) on 02-Mar-2021 for prophylactic vaccination.  The patient's medical history, past medical treatment, and family history were not provided.  List of concomitant was unknown and no other vaccines were reported.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day)  Dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test.  At the time of reporting, 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.
Progressively throughout the week from 02/26/21 to 03/07/21 I felt fatigue and shortness of breath.  By March 7, 2021, I felt as if I had pneumonia.  My chest was tight and it hurt to breath.  I couldn't perform routine duties without struggling to breathe.
Pt developed rash, severe soreness, and fatigue for 1 week (sleeping 11 hours/day). Rash is on bilateral arms.
Patient stated she had a knot with redness at the injection site. Upon examination, the knot had gone away, but redness still remained at the injection site 3 days post vaccine administration. Patient still complained of soreness in arm, but was able to move it more than had been in the previous days.
Patient was admitted to the hospital on 08/22/2021 with nausea, vomiting, and shortness of breath. Died on 08/23/2021
This is a spontaneous report from a contactable nurse. A nurse reported similar events for five patients. This is the third of five reports. A nurse reported that a 3-year-old female patient received a fifth dose of pneumococcal conjugate vaccine (the patient had previously received 4 doses on unknown dates). The patient received a dose of PREVNAR13 (lot number 915704) on 09MAR2011 via an intramuscular route of administration in the right arm. The patient had no relevant medical history or relevant concomitant medications and it was reported that the patient is up-to-date on vaccinations. Drug allergies or relevant history was denied. On an unspecified date, the patient developed a reaction at the injection  site characterized by  pain and redness at the injection site. The nurse feels there is a reasonable possibility that the events are elated to PREVNAR13 since the events resulted in a doctor's visit. Relevant laboratory data was unknown. The patient recovered from the events. The nurse did not wish to be contacted for additional information. Follow-up attempts completed. No further information provided. Follow-up (28APR2011): New information re4ported from a contactable nurse includes patient's date of birth and gender, lot number, medical history, product details, and event details leading to the additional codes of vaccination site pain and redness, and outcome.
Lymph node swollen under arm and upper clavicle.  Under arm for 6 days. Clavicle still sore to touch 7 days out. Injection site was sore same day and stayed sore for approximately 3.
I got a flu shot in my left arm and the Tdap in my right arm. Both shots were given very high on my arm close or shoulder socket.  I had no pain at time of either injection but pain became severe about 8 hours after the shot in both shoulders.  The flu shoulder was ok the next day, but the Tdap shoulder has become increasingly more painful each day.  I have limited movement and extreme pain.  I called to the pharmacist to report the problem and he suggested pain killer.  This has not been adequate in restoring motion or alleviating pain.
Arm swelling, tightness in throat, short of breath right after the vaccine was administered. Friday, Aug. 27th Chills and headache. Saturday, Aug. 28th Shortness of breath, headache, chills. Sunday, Aug. 29th Swelling in throat, sob, chills, vomiting, Fever 103. Monday, Aug. 30th Next day hospitalized for 1 week due to full Covid.
DISCOMFORT; A COUPLE HOURS OF FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced discomfort, and a couple hours of fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from discomfort, and a couple hours of fever. This report was non-serious.
Dizzy, weak, pale.  Called doctor but said it was okay because even if blood pressure low not racing, rested all day.  Next day got rash around pneumonia shot.  Took claritin and used hydrocortisone lotion for rash and itchiness, it helped.  Hoarseness started Saturday and continues to today.
Light headed; This is a spontaneous report from a contactable consumer (patient). A 87-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry: not reported), via an unspecified route of administration, administered in arm left on 24Jan2021 13:30 as single dose for covid-19 immunisation (at the age of 87 years). Medical history included macular degeneration, neuropathy and no known allergies. Concomitant medications included metformin, gabapentin and statins. There was no covid prior vaccination and no covid prior vaccination and no other vaccine in four weeks. On 25Jan2021 14:00, the patient experienced light headed. The outcome of event was recovered on an unspecified date in 2021.  Information of Lot/Batch number has been requested.
Patients mother brought him into clinic for left arm swelling  after receiving  flulaval. Patient seen by Provider prescribed CEPHALEXIN 250/5 SUS 100ML 250 SUSP. and DIPHENHYDRAMINE 12.5/5 118M 12.5 Liquid.
Local swelling and redness distal to injection site (R) arm (deltoid). Fever up to 102 about 24 hours after injection. Anorexia w/o N/V/D.
This spontaneous report as received from a consumer (patient's mother) refers to a 3 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in December 2012, the patient received 2 doses of the M-M-R II injection, subcutaneously (exact dose, lot #, expiration date and therapy type were not provided) on the same day. The patient's mother also reported that the patient had a speech delay, on an unknown date after the vaccination and on 14-OCT-2015, was diagnosed with autism. The outcome of the events and causality assessment were not provided. Upon internal review, the event of autism was considered to be medically significant. Additional information has been requested.
Received FluMist when it was marked asthma on his sheet. FluMist was also marked.
Daily dizziness since administration of second shot: dizzy when moves head, blacking out, feeling like passing out
Loss of taste and smell; Loss of taste and smell; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 17Apr2021 at 10:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 19Apr2021, the patient experienced the loss of taste and smell for 2 days 3 days after receiving the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 20Apr2021, the patient underwent COVID-19 test via nasal swab and the result found to be negative. The clinical outcome of the events loss of taste and smell was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
pt vaxed DEC92 & devel pain @ the pnu-imune inject site & shoulder pain; pt only able to move arm 80 degrees w/o pain; no visible erythema; treatment included non-sterodial, anti inflammatory med; pain ongoing & resembling tendonitis;
While doing inventory, noticed this patient received entire vial of Pfizer COVID vaccine.  Vial was suppose to be diluted and have 3 doses in each vial.  It was not diluted and patient given 0.3ml, which was all 3 doses.
This spontaneous report received from a physician via nurse referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The physician reported to the nurse that he/she had a difficult time removing a ROTATEQ 1 DS X 10 TUBES 00006404741 2 ml oral solution cap and punctured the tube with a needle then snipped the top off with scissors and proceeded to give the oral solution to the patient. No adverse effect reported. It is unspecified what dose in the series this was. Additional information is not possible as the permission to contact physician was not available.
1 day p/flu vax pt devel itchy rash on neck, arms, abdo; pt seen by another MD & was given Kenolog & seldane;
Pt recvd vax & that noc exp 1 episode of nausea & vomiting;
5 minutes into the 15-minute observation period patient fainted; after using the ice pack patient slowly felt better.
1hr p/vax runny nose, watery eyes, itchy mouth;tx in ER w/DPH;
The patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies were not provided.  On 03-AUG-2020, the patient was vaccinated an with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose and frequency were unknown by the reporter; strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T005401 has been verified to be valid, expiration date reported and validated as 12-AUG-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (dose, frequency, lot number, and expiration date was unknown by the reporter).  The administered dose of the vaccine experienced a temperature of -5.3 degrees Celsius (C) for 65 hours and 21 minutes, and a temperature of 15.2 degrees C for 47 minutes, as recorded by a data logger. The previous temperature excursion reported was of -1.2 degrees C for 42 minutes.
Starting ~1:00am shivering, transitioning to clamminess and night sweats.  Waking up ~5:00am with a fever, clamminess, and fatigue.  Took Ibuprofen to reduce symptoms.  Symptoms continued throughout the day.  Went to bed ~9:00 pm, continued throughout the night with clamminess and night sweats.  Woke up ~8:00am with no fever feeling slightly better with a little brain fog.
Developed soreness at injection site the day of vaccination. The next day developed pain in back of head and neck, fever and chills, and joint stiffness. Two days later still had low grade fever, soreness of arm and general malaise. Symptoms persisted for 4 days.
Mild shortness of breath; mild taste in mouth; mild swallowing difficulty; faster heartbeat; WEAKNESS IN LEGS; feeling of tiredness; This spontaneous report received from a patient concerned a 66 year old of unspecified sex. 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, and batch number were not reported) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced mild shortness of breath. On MAR-2021, the subject experienced mild taste in mouth. On MAR-2021, the subject experienced mild swallowing difficulty. On MAR-2021, the subject experienced faster heartbeat. On MAR-2021, the subject experienced weakness in legs. On MAR-2021, the subject experienced feeling of tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild shortness of breath, mild taste in mouth, mild swallowing difficulty, faster heartbeat, weakness in legs, and feeling of tiredness on MAR-2021. This report was non-serious.
This spontaneous report was received from a nurse referring to a 65 year old female patient. The patient had not pertinent medical history, drug reactions/allergies, concurrent conditions or concomitant medications. On 01-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, lot # N025384 with expiration date 19-APR-2019, for prophylaxis (dose and route of administration were not reported). On 02-MAR-2018, the patient experienced redness, warmth and bumpy skin. It was stated that the redness, warmth and bumpy skin spread across the patient's deltoid area. No laboratory diagnostic test was performed. At the time of reporting, the outcome of the events was reported as recovering. The causality assessment between the events and PNEUMOVAX 23 was not provided.
Information has been received from a licensed practical nurse concerning a 21 week old female who was vaccinated with a first and second oral dose of rotavirus vaccine (human-bovine) on 20-DEC-2006 (lot # 655174/0848F) and 21-FEB-2007 (lot # 656188/1238F), respectively. There was no adverse event after the first dose. On 20-MAR-2007 the patient developed multiple episodes of diarrhea which was confirmed to be rotavirus. A stool test was done. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Further information has been received from the nurse concerning this five ) HlB conj vaccine (OMPC) ( lot # 655079/1435F) on 21-FEB-2007. On 19-MAR-2007 the diarrhea was foul smell and a stool specimen was sent. On 29-MAR-2007 the stool sample came back positive for Rotavirus. IT was reported that the patient had recovered on an unspecifed date.month old female with no known allergies or medical conditions and no illness at the time of vaccination who on 21-FEB-2007 was vaccinated with the second dose of oral dose ROTATEQ in combination with diphtheria toxoid (+) hepatitis B virus vaccine rHBaAg (yeast) (+) pertusis acellular 3-componenet vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid PEDIARIX . Further information is not expected.
Donor returned to donate on 077/19/05, donor was asked about reaction from Immunization. Donor stated her throat felt like uvula was longer than normal, hanging down into her throat getting caught when she swollows. Along with her right side of her face swollen, she stated to me this begun on the morning after her immunization.
while in waiting area post vaccination pt started exhibiting sx of anaphylaxis. he was treated by EMTs onsite with Epi and transported to a local healthcare facility.
This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was reported. On 12-AUG-2017, the patient was vaccinated at Pharmacy with ZOSTAVAX 19400 plaque-forming unit (PFU), 1 dose, subcutaneously in the left arm (lot # and expiration date were not provided) for prophylaxis (reported also as : "to prevent shingles"). Other suspect therapies included sterile diluent (Merck). On 23-OCT-2017, the patient sought medical attention and called the pharmacy to report that from 12-AUG-2017 (reported also as:"since the vaccine"), she has had "pain at the injection site that shoots down the arm". The pharmacist reports also that, the patient stated that, "the pain persists, but it comes and goes". No rash and no bump at the injection site was reported. No lab tests were done. The outcome of adverse events was reported as not recovered. The relatedness between adverse events and ZOSTAVAX was not reported. No product quality complaint was involved.
Fever, chills, shaking, joint and abdominal pain. Pain at injection site. Nausea. Bad headache. Fatigue. Loss of appetite.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for Covid-19 immunization; Bnt162b2 (DOSE 1), for Covid-19 immunization. The following information was reported: EYE OPERATION (medically significant), outcome "unknown", described as "eye surgery"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "cancer". Clinical course: Caller is a consumer who's asking about the Pfizer Covid-19 vaccine, and whose past medical history was significant for cancer. She also notes that she is bedbound, and would like to know "how I can get somebody to come to my home and give my first booster"? She also notes, "her husband had cancer and had eye surgery recently, he needs his 2nd booster". Possible AE noted after call, both patients mentioned have cancer and have had the Pfizer Covid-19 vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Post vax, a few months ago from the time of the report, the patient developed varicella. Subsequently, the patient recovered. Unspecified medical attention was sought.
received a full dose instead of a half dose; had a reaction to every dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a reaction to every dose) and ACCIDENTAL OVERDOSE (received a full dose instead of a half dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 393906, 044921A and 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (had a reaction to every dose). On 28-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (received a full dose instead of a half dose). In August 2021, VACCINATION COMPLICATION (had a reaction to every dose) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (received a full dose instead of a half dose) outcome was unknown.            Concomitant medication included medication for High blood pressure and blood thinner.  Patient got booster at a market and was not officially approved then so received a full dose instead of a half dose. Patient had reaction to every dose when received and it went away in a day or two.  Patient did not take any medications for any reactions.   This case was linked to MOD-2021-307576, MOD-2021-307152 (Patient Link).
Local redness, swelling, and inflamation 5.5cm X 5.5cm.
Patient reported feeling dizzy and had emesis After patient stated symptoms resolved Patient seen by medical team , refused medical transport and signed AMA form
1 week after shot, developed large rash at injection site, maybe 4 to 5 inch diameter. Skin is red and raised, warm to touch, and mildly itchy.
Heat, redness, swelling, induration at injection site covered 1/3 of upper arm on 6/26/15. Redness went down to elbow on 6/29. On 6/28 Lt parotid area swollen and tender to touch. Unable to bite down on Lt side from afternoon->late night. 6/29 area tender but able to chew.
Patient was awakened in at 3:30 am with soreness in the area so bad that it could not be touched. Took Advil all day but didn't feel better. Went to see a Dr. on 09292017 with a fever of 101.5. The doctor diagnosed the problem as cellulitis and suspected the cause was from the immunization. Patient was prescribed antibiotics for treatment.