chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aches in the lumbar area and legs; aches in the lumbar area and legs; she felt extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (aches in the lumbar area and legs), PAIN IN EXTREMITY (aches in the lumbar area and legs) and FATIGUE (she felt extremely tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced BACK PAIN (aches in the lumbar area and legs), PAIN IN EXTREMITY (aches in the lumbar area and legs) and FATIGUE (she felt extremely tired). On 11-Feb-2021, BACK PAIN (aches in the lumbar area and legs) and PAIN IN EXTREMITY (aches in the lumbar area and legs) had resolved. At the time of the report, FATIGUE (she felt extremely tired) outcome was unknown.
Mom called & spoked w/MD mom states pt had blisters, next day fever, "flu sxs"; has hx "cold sores" especially a/illness; No residual problem x/redness @ cheek site 25NOV91;
Allergies: PNEUMOCOCCAL 23-VAL PS VACCINE (reactions not documented); This spontaneous report was received from a physician assistant (PA) via Pfizer referring to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (dose, lot #, expiry date, and route of administration were not provided) for prophylaxis.  On an unknown date, the patient experienced allergy to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reactions not documented). At the time of reporting, the outcome of the event was not known. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).
I was almost immediately struck with persistent debilitating pain that radiated throughout my upper left arm caused by any movement of hand, forearm, or shoulder. It finally lessened and dissipated in February 2017.
Temp of 105 for 2 days - high pitch scream; shook, cried, wouldn't eat or drink - didn't sleep threw up a little; just screamed & right p/the fever broke got a real bad ear infection; Within 8 hrs of shot all this happened.
Shortness of breath 1st noticed around the time of vaccination series started in 2003. Tx-ed for pneumonia- with no change cardiac workup including stress test in April 1 2004 was normal.
pt recvd vax & devel rash; pt may have had a possible allergy & subsequently devel variciella;
On date of vacation 1/14/21, I had no reaction other than a slightly sore left arm which was better the next day and I had no other symptoms until today.  Today 1/22/21, 8 days later, I woke up with my left arm sore at the vaccine site and when I looked, I found a bright red circle about 2" in diameter around the site.  It is not hot to touch or sore - just a little itchy.  Since the vaccination I have used no ointments or lotions on my arm, have done the same exercise each day, and have had no bump or accident to my arm.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 2-5, units not reported) of unknown gender. On 20-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies were not provided. It was reported that the patient received doses of RECOMBIVAX HB 5/0.5 microgram/mL, on 11-JUL-2012 for first dose, second dose on 27-SEP-2012, third dose on 25-OCT-2013, and fourth dose on 11-JUL-2014 (route: intramuscular, lot # and expiration date not provided for any dose). The patient had not demonstrated any adverse effects. Additional information has been requested.
Injection in lower arm on Oct 10th. On Oct. 12th in the evening, right arm brightly reddened approx 1 inch around injection site. Warm. Borders of redness marked. Next day (Oct 13th) redness noted beyond where borders were marked the night before, but the color of redness was less.
Pt received the MMR vaccine on 4/3/07, the next day he returned to employee health complaining of a rash, achiness and feeling poorly. He was seen by the occupational med physician and treated with Allegra. He was told to return to work and no further follow up was needed.
Pt recvd MMR vax end of SEP90; 5 to 7 days later began to exp relapsing episodes of urticaria; Condition improved w/tx of Epi; @ time of report urticaria involved entire body had been referred to an allergist;
First dose was on 01/09/21 no reaction 2nd dose was on 02/06/21 cold and flu symptoms for 1 day.  With in 2-3 weeks increase abdominal pain, and discomfort, I thought it was a Crohn?s flair, so I just tried to wait it out.  Early April I went to the ED, for eval and treatment , it was discovered via CT of abdomen I developed Portal Vein Thrombosis, admitted for anti coagulation, and further studies like JAK 2. Place on heparin, followed by lovonox SQ injections, and bridged to Pradaxa.  Symptoms returned after a couple of weeks, and persisted, ,back tp the hospital new CZt scans, showed increase in Portal vein thrombosis, but now included splenic vein thrombosis, and mesenteric vein thrombosis.  Went back on anticoagulation therapy, transferred to  hospital for Intervention Radiology procedure to have a portal vein shunt placed in, and thrombectomy of the spleen, and mesenteric veins. Had bleeding issues, returned to OR for a second IR procedure, and finally a 3rd procedure of splenectomy, blood transfusion for hemorrhagic shock.  Discharged on warfarin, and lovonox as needed
This spontaneous report as received from a registered nurse via company representative refers to a patient of unknown age. On 15-AUG-2013 the patient was vaccinated with an expired dose of GARDASIL (lot # 0692AA, Exp 13-AUG-2013) (dose, frequency and route unspecified). No adverse effect reported. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Starting on the 8th day after receiving the vaccine, the vaccine site started to itch. It has a red spot and is hot to the touch.
Swelling, tenderness, warmth, and redness in L arm (deltoid) at site of Hepatitis B and Flu Vaccine injections. Area of swelling measured with 60mm diameter.
patient was down for 3 days after taking pfizer vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An adult male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "patient was down for 3 days after taking pfizer vaccine".  Additional information: patient age was reported as 35-49, age group adult.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included milk allergy. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The patient received FLUARIX vaccine last year. The patient had a strong allergic reaction to the vaccine. The patient could not find anywhere on the site the list of ingredients in FLUARIX. The patient suspected since GlaxoSmithKline made both of these they may use the same base of stabilizers as lactose. The patient wanted to know what she can do about a flu vaccine this year. The patient wanted to know does GlaxoSmithKline manufacture available vaccines without the top 8 Major Allergens. The patient also wanted information should be included in the disclosure of these allergens. This case was linked to the case US2018GSK118116, reported by the same patient.
Patient in for Anthrax and TST on 7 Jan 08.  Patient returnd to clinic 8 Jan 08 wht lfa swollen and red at site where TST was thought to be placed and no reaction in left deltoid where anthrax was thought to be placed.  Due to the simularity of the 2 vials the immunization tech beleives the anthrax was placed in the lfa id and the TST was placed in the left shoulder SC.
Day of injection (01/28/2021) plus 3 hours Approx 12 noon. 4 bouts of Diarrhea lasting several hours. Two days post injection (01/30/2021) 11:A.M. 2 bouts of Diarrhea over two hour period. Two days post injection (01/30/2021) 10:00 P.M. Broke out in a full body sweat, weakness with heart rate 120 bpm. Cooled off by using cool wet towels and rested for two hours. Heart rate down to 75bpm. Heart felt like skipping beats for another hour. Now Sunday morning (01/31/2021) and feel normal
2 episodes of dizziness;1st episode 2hrs p/vax lasting 30seconds,2nd event about 10hrs later lasting about 10 seconds;no other sx;
Received steroid shot after 1st vaccine shot; This spontaneous case was reported by a consumer and describes the occurrence of STEROID THERAPY (Received steroid shot after 1st vaccine shot) 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 STEROID THERAPY (Received steroid shot after 1st vaccine shot). At the time of the report, STEROID THERAPY (Received steroid shot after 1st vaccine shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
2 d. after administration of Varivax and Prevnar child came in with molted skin and rash from head to toe - Afeb. fever ox normal CBC WNC
Immunizations given 10-17-07. School nurse called mother on 10/22/07 informed her child had rash over body. No drainage or fever.
Patient was administered 1 of 2 series of the Moderna Covid19 vaccine.  it is our understanding that Moderna is not approved for use under the age of 18.
Sick; Blood pressure spikes; mild temperature; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure spikes), ILLNESS (Sick) and PYREXIA (mild temperature) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Multiple sclerosis. Concomitant products included FINGOLIMOD, DULOXETINE HYDROCHLORIDE (DELAXIN) and VITAMIN D NOS for an unknown indication.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 BLOOD PRESSURE FLUCTUATION (Blood pressure spikes), ILLNESS (Sick) and PYREXIA (mild temperature). At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure spikes), ILLNESS (Sick) and PYREXIA (mild temperature) outcome was unknown.            Treatment information was not provided.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-122205 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
45 min. post vx baby became irritable and felt warm. Next day in afternoon, fever of 105. Went to E.R. who said symptoms related to an infection, not the flu shot.
Rebound Covid 6 days after negative test, 4 days after completing the antiviral drug; Rebound Covid 6 days after negative test, 4 days after completing the antiviral drug; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65 year old male patient received BNT162b2 (BNT162B2), on 25Mar2021 at 13:15 as dose 1, single (Lot number: ER8727), in left arm, on 15Apr2021 at 16:30 as dose 2, single (Lot number: EW0161), in right arm and on 26Oct2021 at 14:30 as dose 3 (booster), single (Lot number: FH8020) at the age of 64 years, in right arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Rebound Covid 6 days after negative test, 4 days after completing the antiviral drug". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient had no known allergies and no other medical history.  No follow-up attempts are possible. No further information is expected.
Headache, nausea within an hour of the shot. Vomited after 2 hours.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog), MYALGIA (muscle ache) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L2OA) for COVID-19 vaccination.    No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (muscle ache) and HEADACHE (headache). On 23-Jan-2021, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, FEELING ABNORMAL (brain fog), MYALGIA (muscle ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Arm pain, swelling, redness, re-evaluated in clinic 11/15/2019 3x4 cm raised erythematous nodule with tenderness to palpation, treated with ice and NSAID, rechecked with mom 11/18/19, improved over the weekend and resolved
Received his first dose 14Dec2021 and then was diagnosed on 20Dec2021 with Covid 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101863332 (Pfizer), US-PFIZER INC-202101863400 (Pfizer).  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 20Dec2021, outcome "unknown", described as "Received his first dose 14Dec2021 and then was diagnosed on 20Dec2021 with Covid 19". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporting nurse stated that her 11-year-old son received his first dose of the Pfizer BioNTech COVID-19 vaccine pediatric formulation (orange cap) on 14Dec2021, and he ended up testing positive for COVID-19 on 20Dec2021. He was scheduled for his second dose on 04Jan2021 and was seeking guidance whether patient has to wait to receive his second dose or not.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient was inadvertently given Menactra instead of the ordered HPV vaccine; patient had received the Menactra at 11 years and again received at 12 year inadvertently; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 years old female patient who was inadvertently vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6151AA, expiry date: 16 March 2020 via unknown route in the left arm on 17-Apr-2019 instead of HPV vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to Wrong vaccine administered and extra dose administered.  It was reported that patients had received the Menactra at 11 years for routine vaccination and at 12 years, the patient was inadvertently given Menactra instead of HPV vaccine.  It was not reported if the patient experienced any adverse event following vaccination.  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.  List of documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a 20 year old female patient. On 26-AUG-2017 the patient was vaccinated with VARIVAX lot # L011085 in the left arm for prophylaxis. Other suspect therapies included sterile diluent and M-M-R II. On 26-AUG-2017 the patient experienced expired product administered. On 27-AUG-2017, 28 days after onset of therapy the patient experienced rash. The outcome of rash and expired product administered is unknown. The reporter considered expired product administered to be not related to M-M-R II, VARIVAX and sterile diluent.
7 days ago I received the Covid vaccine, no symptoms. Today, my injection site began to hurt. It is swollen about the size of a baseball. It is red, hot, and itches. Our school nurse (I am a teacher)sent us a link about Covid arm. The link suggested reporting the issue for data collection purposes.
pt states his normal rash which is currently on both elbows and hands has developed heavily from his neck to his knee area and is on both legs.  These spots had small blisters w/ liquid in them.  Pt saw his PCP on 1/11 before taking the covid vax that he was given later same day.  Pt saw his PCP on the 1/14 after his developing his bad rash so his PCP thought this must have been caused by the vax.  Pt was ordered some medicine for his rash but never received it so used some Clobetasol ointment 0.5 that he uses on his everyday rash and seemed to work pretty well for it.  Pt states blister have disappeared but left black spots where they had formed.
16JUL t013.4 rx Panadol & cool water bath; 230PM MD post vax fever & fussy rx Panadol; 17JUL afebrile/mom taken fluid appetite dec; 23JUL mom states pt fine still not eating as well;
NO ADVERSE EVENT AS OF TODAY (10/24/17) - PATIENT NOTIFIED BY PHONE AFTER ERROR WAS DISCOVERED.
Patient stated she took the vaccine on Thursday 3/11/21 and about 3 days later she started to feel a cramp in both of her legs. On 3/27 patient stated she couldnt move and felt like a tingling sensation on the left arm (felt like ants crawling on body), felt dizzy, headache. She stated she then went to the ER on 4/15/21. CT scan (chest) and ultrasound(legs) was done and she wasnt sure of the results (the ER doctor only informed her that she wouldnt be #7). Then on 4/17 patient state she felt fine and was back to exercising and running.  Then on 4/24 she stated she went to the beach to run and felt a sting/cramp on right leg, she looked and noticed a bruise and then as of 4/26 her leg is sore, it's not red, not hot and not hurting, just sore to touch. Bruising is going away but just uncomfortable to touch.  Patient states she been feeling a little more fatigued and winded out when doing things now more than before  and before taking the vaccine.   Been a 1.5years since her last asthma attack. Since a month ago is when she started to feel that she needs to catch her breath more often. Patient stated she saw her PCP on 4/19/21 and she was prescribed another inhaler (can't recall the name) and antibiotic.   CT scan was done when she was in the ER because pt had chest pain. No pulmonary embolism indicated on results but she states her scan came back with something on it but she wasnt able to explain what was on there. When she was in the ER the doctor didnt prescribe anything but when she went to see pcp her MD prescribed her an antibiotic (cant recall name, she picked up the rx but hasnt started taking it yet- wasnt home to obtain the name).   As of 4/26 her headache, leg cramps have subsided, she just feels very fatigued. She stated that every time she has a headache she takes tylenol. The last time she took tylenol was on Sunday 4/25/21.  Advised patient to start taking the antibiotic as prescribed by the pcp and to take the inhaler when she feels winded out. Also advised her that if she feels chest pain or extreme sob then to either contact her pcp again or urgent care  She has no follow up scheduled with her PCP.
Beginning at approximately 9pm on 03/13/2021, my upper arm  became very sore and nausea started.  By 7am on 03/14, I was extremely chilled and still nauseated, however   my arm soreness was subsiding. I fell back to sleep and woke up about 2pm. I had finally warmed up but still slightly nauseated.  By 6pm, I ate some dinner and today, 3/15, I feel normal.
Fully vaccinated with 3 doses of Pfizer. Tested positive for COVID 19 on 01/24/2022. Admitted to Hospital on 01/08/2022. Expired on 02/08/2022 while still hospitalized.