chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received both IPOL and PENTACEL expired doses/ NO AE; Initial information received on 22-Jun-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional and physician via call center via Medical Information (reference number- 00651323).  This case involves a 3-years-old male patient who was vaccinated with an 0.5 mL expired dose of IPOL (frequency: once, strength: standard, lot number : R1B251M and expiry date : 13-Mar-2021, via an intramuscular route in right arm) and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (frequency: once, strength: standard, lot number and expiry date not reported, via an unknown route at an unknown administration site) (expired product administered) on 21-Jun-2021 for prophylactic vaccination.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.    Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency: same day).  Caller with question on whether doses are viable or whether dose needs repeating. Caller also with question on any adverse reactions to expect due to dose of IPOL in addition to dose received with PENTACEL.   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.
11/1/12 Wrong strength of Hep B vaccine given to patient. Adolescent dose instead of adult strength. Pt. has now completed Adult Hep B series as of 6/26/13.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. Later in-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Within 15 minutes of vaccine - vertigo, cold sweats, chills.  After 30 minutes came to pharmacy.  Given 25mg Benadryl.  After 45 minutes emesis x 2.  Stayed with patient til husband picked her up from work.  Would not allow us to call 911 - no insurance.
Onset 3/17/03 with several raised and itchy vesicles, moderate. On 3/18/03, on scalp, back and face.
Two weeks after second immunization patient experienced itchy arm with rash. After 2 more weeks patient started feeling tingling sensation from his neck to fingers on left side of body
t102, red skin 9flush bright red);c/o nausea;saw MD;labs drawn;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I tested negative for several days; (unspecified date) Positive, notes: I'm testing positive again; (16Dec2022) Positive, notes: I'm testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with VAQTA (strength, dose and frequency not reported) (route, lot# and expiration date not provided). It was reported that VAQTA was exposed to a supported temperature excursion on 06-OCT-2014 and had been administered to unspecified patients on unspecified dates since the excursion on 06-OCT-2014. No adverse effects had been observed or reported. This is one of several reports received from the same reporter. Additional information has been requested.
(1) Low grade Temp to 99.7, (2) Fatigue, (3) Local erythema, warmth, pruritis and swelling.
Shingles; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Apr2021, two or three days after getting the vaccine patient developed shingles which were being treated with Valtrex and gabapentin. It was reported that the patient was scheduled to get the second dose of the vaccine on 10May2021. It was mentioned that right now they do not have any open lesions and want to know if they can still get the second dose on the 10May2021. The outcome of shingles was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Patient became dizzy and red spot at sight of injection. He went to the ER 11/5/2015 in the evening. The ER MD diagnosed patient with cellulitis, prescribed Keflex 500 mg po TID x 7 days. Follow up visit with MD 11/11/2015 resolved-no sequelae.
Got flu vaccine at 1330. Around 2000 started wheezing and chest got tight. Used home nebulizer without relief. Took Benadryl 25 mg. Not getting better. Took another Benadryl 25 mg and nebulizer treatment. Not much better went to ED.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. Date place in refrigerator 22-Sep-2021. Vaccine did not undergo any temperature excursion and patient not experienced any adverse event. No treatment details were provided.
Modern COVID-19 vaccine   Patient collapsed on bathroom floor 20 hours post injection.  Could not get up 911 summoned  and taken to ER.  Given fluids and Tylenol for excess immunologic response.  Loss of fluids excessive about 12 hours post injection.  Loss of taste 24 hours after injection. Dry cough 48 hours after injection.   Long dormant herpes simplex eruption 72 hours injection.   Fever continued for 48 hours after injection but controlled with tylenol.
Pressure in head; Muscle contractions in both arms; Tingling in arms and legs; Light headedness; This spontaneous case was reported by a medical assistant and describes the occurrence of HEAD DISCOMFORT (Pressure in head), MUSCLE TWITCHING (Muscle contractions in both arms), PARAESTHESIA (Tingling in arms and legs) and DIZZINESS (Light headedness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Pressure in head), MUSCLE TWITCHING (Muscle contractions in both arms), PARAESTHESIA (Tingling in arms and legs) and DIZZINESS (Light headedness). At the time of the report, HEAD DISCOMFORT (Pressure in head), MUSCLE TWITCHING (Muscle contractions in both arms), PARAESTHESIA (Tingling in arms and legs) and DIZZINESS (Light headedness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's doctor ordered  an MRI to look further into symptoms. no concomitant medication provided. No treatment medications were reported.
received dose from a vial punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (received dose from a vial punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (received dose from a vial punctured more than 20 times). On 19-Nov-2021, PRODUCT ADMINISTRATION ERROR (received dose from a vial punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported. The reporter is pharmacy internship.
Extreme hives for 4 weeks and continuing. All over body. Itching , inflammation and hives.
I started to have abdominal pain after I'd gone to bed on 2/26/2021.  I went to the ER on 2/27/2021 and was diagnosed with appendicitis.  I was operated on the morning of 2/28/2021- appentectomy.
No additional AE reported; Medical assistant reported PROQUAD was administered after a temperature excursion to multiple patients. This case is for patient three of four.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and therapies were not reported.  On 04-AUG-2022, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) once, lot #: W010061, expiration date: 20-SEP-2023 (exact dose, strength, formulation, site and route of administration were not provided) for prophylaxis. Temperature excursion information: 5.56 degree Fahrenheit for 3 hours and 30 minutes. No previous temperature excursion. There was no additional adverse event reported.
I became sick with nausea, dizziness, a "floating" sensation, PVCs (weird heartbeats which I have never had before) , tachycardia, sudden "cold" symptoms with trouble breathing and speaking which usually resolve in an hour or so, greatly heightened sensivity to head and cold (particularly cold), and extreme fatigue.  I have to take Metoprolol ER 50 mg a day now to control these PVCs and tachycardia recommended by Dr. and Dr. confirmed this is the best course of action at this time.  These acute symptoms lasted about a week and I slowly began feeling better but I still have the problems now, and a feeling that something is basically wrong and it probably won't change.  I think this is permanent since it has been over 3.5 months.  I had Roux-en-Y surgery on 8/1/2018 which weakened my immune system and Dr. and my cardiologist Dr. both suspect this may have had something to do with my severe reactions.
Approx 7 days p/inject nausea, vomiting, fatigue, chills, diaphoresis, rash, frontal h/a & fever; admitted to Hosp 27JUL-9AUG91
Fever 101-102 degrees, diarrhea, raised rash, generalized itching, dizziness, jerking of extremities-all began approx. 6 hr post vaccine and lasting until 2-16-07-symptoms persist as of 2:30pm, topical Caladryl, oral Benadryl
Intense sweating, chills and hot flashes. Metallic taste in mouth. Had flu vaccine with covid vaccine. Over awful feeling for past 5 days.
Feverish; Local soreness; Moderate fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: 8733) via an unspecified route of administration on an unknown date in Apr2021 (at the age of 59-year-old) as a dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced feverish, local soreness and moderate fatigue. No therapeutic measures were taken as the result of adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event feverish, local soreness and moderate fatigue was recovered on unknown date in 2021.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added age at Vaccination and relevant narrative sentence updated, removed Lab data Body temperature normal and relevant narrative sentence
It was reported that a male patient received TRIPEDIDA, MMR, OPV vaccines and TUBERSOL on April 27, 1999. Reportedly the patient experienced an 8x 9-cm area of swelling and an 8 x 12-cm area of redness around injection site.
Hard lump on upper arm near injection site with redness, felt hot to touch, some tenderness but not too painful.
A little raised area in the middle and it look like an insenct bite right in the area where got injection; Scratching their arm; There was a large roundish area 14 inches in diameter; Hive like raised area at the injection site; Little bit of soreness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (A little raised area in the middle and it look like an insenct bite right in the area where got injection), VACCINATION SITE PRURITUS (Scratching their arm), VACCINATION SITE SWELLING (There was a large roundish area 14 inches in diameter), MYALGIA (Little bit of soreness) and VACCINATION SITE URTICARIA (Hive like raised area at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 11A21A) for COVID-19 vaccination.     The patient's past medical history included Osteoporosis on 08-May-2017. Concurrent medical conditions included Hypertension since 26-Mar-2015.  Concomitant products included MIRTAZAPINE (REMERON) from 30-Mar-2021 to an unknown date, TELMISARTAN from 30-Mar-2021 to an unknown date, AZELASTINE from 22-Oct-2020 to an unknown date, CICLOSPORIN (RESTASIS) from 26-Mar-2015 to an unknown date, CALCIUM from 26-Mar-2015 to an unknown date, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE (MULTIVITAMIN 6) from 09-Feb-2012 to an unknown date, MAGNESIUM, FISH OIL (OMEGA 3 [FISH OIL]), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), ZINC, BIOTIN and CALCIUM CARBONATE (TUMS EXTRA STRENGTH) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (Little bit of soreness). On 28-Jan-2021, the patient experienced VACCINATION SITE REACTION (A little raised area in the middle and it look like an insenct bite right in the area where got injection), VACCINATION SITE PRURITUS (Scratching their arm), VACCINATION SITE SWELLING (There was a large roundish area 14 inches in diameter) and VACCINATION SITE URTICARIA (Hive like raised area at the injection site). On 30-Jan-2021, VACCINATION SITE REACTION (A little raised area in the middle and it look like an insenct bite right in the area where got injection), VACCINATION SITE PRURITUS (Scratching their arm), VACCINATION SITE SWELLING (There was a large roundish area 14 inches in diameter), MYALGIA (Little bit of soreness) and VACCINATION SITE URTICARIA (Hive like raised area at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications also included blood pressure medicines. Treatment details included Topical cortisone.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: ADR Form
2-3 days following the 1 Pfizer dose, she notice brown spots on her left arm and her right elbow was itching.  Since then, the spots are nearly faded away and her elbow has stopped itching.
sick for a day or 2; This case was reported by a consumer and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that his wife had the vaccine about 6 months ago and was sick for a day or 2. He declined to provide HCP information.  The reporter did not consent to follow-up. This case had been linked with US2020254973 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020254973:same reporter
This case was received from a health care professional on 22-Oct-2013. A 56 year old female patient received an injection of FLUZONE (batch number UH890AB), dose in series, route and site of administration not reported, on an unreported date. Patient experienced eyes swollen after 12 hours of vaccination. Ocular reaction alone. Previous two years with flu vaccine had the same. Not sure if FLUZONE in past years.
shoulder pain after vaccination due to injection site being too high on the arm (SIRVA) with signs of subacromial bursitis
Swelling of lymph nodes under arm pit of arm that was given shot, nausea, headache, body aches, fatigue
As an asthma patient I am faithful in getting the flu shot yearly. I have never had a bad reaction, nor a case of flu after having the shot. I got the shot on 9/29/2008. The next day I felt SOB and lethargic. I developed a frequent, productive cough. By 10/3/08 I was running a fever. Sputum was dark green, SOB increasing. Because of my history of respiratory problems, I started prescription cough medicine and antibiotics that day. They have been effective and I am slowly improving.  This may have been an adverse event or simply an unlucky coincidence.
about 12 hrs p/vax administered pt had twitching of arms & legs which lasted for 45 mins on & off while asleep; cried for 2 hrs; fever 101.8;
Nov. 11 - 1st shot, sore throat Nov. 12 - Throat still sore and used inhaler twice that day from excessive wheezing. Left arm a little sore Nov. 13 - Discovered hives on left breast and throat still sore. Took Benadryl to stop itching. Nov. 14 - Hives appeared on both breast and upper part of stomach.  Area where shot was given turned red and became bigger in size approximately quarter size and I could feel a lump.  Took Benadryl to stop itching and reduce swelling. Throat still sore and voice is grasp. Had a rough night sleeping.  Body was aching and my bones were cold.  When I did fall asleep, I could literally feel something running through my blood in my body.  My senses seem like they were heightened and I just felt really weird.  My legs felt numb and I had to wake up and rub them.   Nov. 15 - Hives are now on left arm near shot, but disappearing from left breast.  Still on right breast, upper stomach but fading.  Throat is still sore and grasper than yesterday.  Took another Benadryl to stop itching and took inhaler due to excessive wheezing . Nov. 16 - Hives are now only on my left arm but fading and the swelling where the shot was is back to normal.  Still have this bad sore throat and I had some throat lozenges and hot tea.   Nov 17 - Throat is still sore and voice is still raspy.  Called doctor to get an appointment and filling out this form.
I starting vomiting approximately 8 hrs after shot and it lasted about 5 or 6 hours. I took (ONDANSETRON) 8mg and vomiting finally stopped and I sleep for over 30 hrs. I also had shortness of breath.
1FEB99 mom reported child broke out w/a rash 3 days ago;mom then states child had @ little rash day of shot;mom then states child was dx 3days ago w/an ear infect & was put on amoxicillin;pt had fever 101.6;104.8 & 105;also swollen glands;
Delayed cutaneous hypersensitivity, (COVID arm). Red rash around and below site of injection
Severe pain and burning in the arm. Injection given in the top of shoulder. Surgery on shoulder in Dec '14 - still in therapy Dec 2015.
Day after the immunization patient woke up with swollen arm and knee (the knee in which he had replaced) went to dr..dr said could not rule out infection.
My arm hurt for a couple of days; I got the chills the night I got it; Initial information received on 21-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves patient (unknown age and gender) who had arm hurt for a couple of days (limb discomfort) and got the chills the night (chills), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received INFLUENZA VACCINE (batch and expiration date unknown) at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) the patients developed arm hurt for a couple of days (limb discomfort) and got the chills at the night (chills) (non-serious event).  No laboratory data reported.It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will no information on the batch number for this case.