chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DTAP ADMINISTERED IN RIGHT DELTOID 8/22/05. PATIENT RETURNED 8/24/05 FOR PPD MANTOUX SKIN TEST READING.  RIGHT DELTOID NOTED TO BE RED, SWOLLEN, HARD AND PAINFUL.  AREA WAS MARKED WITH  INK PEN SURROUNDING THE INDURATION.  STUDENT WAS INSTRUCTED TO FOLLOW-UP WITH PEDIATRICIAN. APPT. MADE FOR 8/26/05.
Pt vaccinated with DTP/OPV while diaper being changed, baby turned pale/white/blue around mouth, unresponsive lasted a few seconds only.
Chest X Ray: Slightly enlarged heart; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN8733; Expiration Date: 31Jul2021), dose 2 intramuscular, administered in Arm Left on 06Apr2021 10:00 (at the age of 82-year-old) as dose 2, single for COVID-19 immunization. Medical history included, arthritis from 2005 and ongoing, asthma from 2008 and ongoing, heart from 2018 and ongoing (Stent inserted), thyroid from 2007 and ongoing (No new suspected but not found partial removal of thyroid gland), enlarged heart (father) from an unknown date and unknown if ongoing (family history), heart attack (brother) from an unknown date and unknown if ongoing (family history). Concomitant medication(s) included sulfasalazine taken for arthritis; levothyroxine taken for thyroid; montelukast taken for asthma; salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for asthma; metoprolol taken for heart; lisinopril taken for heart; prasugrel taken for heart from an unspecified start date and ongoing. The patient previously received first dose of BNT162B2 (Lot Number: EN6206; Expiry date: 30Jun2021), intramuscular administered in Left arm on 16Mar2021 10:00 (at the age of 82-year-old) for COVID-19 Immunization and experienced worst ever asthma attack. Prior vaccinations (within 4 weeks) were none reported. On 21Apr2021, patient experienced chest x ray: slightly enlarged heart. Reported, follow the 1st vaccine short, my doctor told me to immediately follow the 2nd vaccine shot with some albuterol at 4hr, inhaling for the day of the 2nd. Patient did and had no problem after the 2nd shot. The patient underwent lab tests and procedures which included stress test: everything works ok on 15Apr2021, chest x-ray: slightly enlarged heart on 21Apr2021. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
20 minutes after the Moderna COVID vaccine, I had numbness in my upper lip, then a couple hours later, I have numbness in my lower lip.  The next day, I had numbness in my left cheek, chin and upper neck.  Most of my left face has been numb. I took Advil, Ibuprofen and Zyrtec with no improvement.   I have taken 7 days of high dose prednisone with no improvement.   It is very frustrating and I hope that I will feel better soon!
Pentacel, Menactra, Fluzone "Pediatric" or Quadrivalent 0.25 mg, and Fluzone Quadrivalent 0.5 mg that was too cold (29-33 ºF for 20 days); Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 3 patients (kids) of unknown demography who received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that Pentacel, Menactra, Fluzone "pediatric" or Quadrivalent 0.25 mg, and Fluzone Quadrivalent 0.5 mg that was too cold (29-33 ºf for 20 days).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient received a dose of suspect 0.25 mg INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. 1 other doses were administered on unknown dates for suspect 0.5 mg INFLUENZA QUADRIVAL A-B VACCINE.  It was a case of actual medication error due to incorrect product storage.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
I had a sore throat, cough, and lethargy. I took an at home COVID19 rapid test, which was positive, the morning after the symptoms began. I scheduled a tele-health visit that same day. Because I did not have any recent kidney or liver analysis they asked me to come in and have some blood drawn. They then prescribed Paxlovid and Tessalon Perles. I had a few days of fever and malaise. After I finished the Paxlovid I had a few more onset of symptoms develop and scheduled another telehealth appointment but it was mild enough that they didn't want to do anything else.
Patient had dizziness and had vomiting - (next day) was pale - weak - same day of vaccine.
Muscle spasm in arm, headaches. FIORICET, Tizanidine prescribed.
Started "feeling very bad" immediately after injection given. Reports to have pounding headache, couldn't focus on school on Wednesday, went home and slept all afternoon. Same symptoms noted today Thursday 1/23.
Fever (102.2 F), headache, injection site pain, fatigue, shivering.
Patient seen at emergency dept after c/o syncopal episode while at work. Patient felt dizzy, lost consciousness & hit top of head. (no fall certain)
chest, back, joint pain w/in 48hr;tingling & numbness in  fingers & toes w/in 2wk;weak & severe paralysis w/in 2wk;hosp for 97 days;dx GBS;  Per follow-up, the pt still experiences foot pain and partial paralysis with nerve damage.
Fever 101.6, chills, sweating Racing heart while resting Chest tightness Congestion muscle aches dizziness weakness fatigue brain fog
swollen lymphnodes under my armpit; headache; redness around injection site; spans about 2 mm; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (swollen lymphnodes under my armpit), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness around injection site; spans about 2 mm) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymphnodes under my armpit), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (redness around injection site; spans about 2 mm). At the time of the report, LYMPHADENOPATHY (swollen lymphnodes under my armpit) and HEADACHE (headache) outcome was unknown and VACCINATION SITE ERYTHEMA (redness around injection site; spans about 2 mm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On Jan 2022 patient received booster dose of Moderna (two days ago). On Jan 2022 patient experienced swollen lymph nodes under armpit and headache(on first day). No concomitant medication were reported.   No treatment drug were reported.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 19-JUN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # S000132 and expiry date 02-JAN-2021) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.  This is one of several reports received from the same reporter.
On 2.27.03 patient felt her eyes were puffy @ 1030.  She took benadryl 25mg po.  At 1130 wen out side x 30minutes.  Started to feel "funny" inside.  she returned to the building sat down and 911 was called.  BP 140/80.  In the Rmergency room reseived IV Tagamet, Benadryl and Solu medrol.  Good relief of symptoms.  Home to with benadryl.  will see MD in the am for follow-up.  The pollen count and the red tide are documented to be very high today.
I had the vaccine on 2/16. On 2/22 at 5:30 pm  I suddenly started having double vision. I saw an eye doctor that evening. I had no face drooping. I had not headache or muscle weakness and my pupils were the same size. If I covered one eye (did not matter which one) the double vision was not present. The next morning 2/23 I woke up with no double vision but throughout the day it came back a few times but resolved each time.  I went to Medical Center on 2/2 and had a complete exam. So far all labs have come back in normal range. I have tracked my blood pressure twice a day since this happened.  BP is great   I am a very healthy person.  Exercise daily. The only thing different in my life is having the vaccine dose. It was my first dose.   The double vision seems to be resolving more and more each day. Happening less and shorter episodes. My eyes have been check by medical extensively on 2/2. They cannot find a reason for the double vision.   I would like to know if this has been reported by anyone else  and if so did it resolve. Also if the person took the second dose and did they have problems. I am supposed to have my second dose on 2/16.  I am not sure what I should do.  I still have symptoms although they are much milder and seem to be resolving.   I have never felt bad at all during any of it and have continued to exercise.
By Friday, 10/20/2017, developed pain in left shoulder that became more severe over the weekend. It got too agonizing to where I couldn't sleep so I went to the local hospital around 1:30 am.
Fever, chills, extreme fatigue, joint pain, headache, and tinnitus. Everything lasted about 5 days except for the tinnitus. The tinnitus varies in severity and is present everyday since the first dose.
shingles; lethargic; tingling in right leg; Just a weird feeling in my right leg; rash developed on my leg right thigh buttocks; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PARAESTHESIA (tingling in right leg), FEELING ABNORMAL (Just a weird feeling in my right leg), RASH (rash developed on my leg right thigh buttocks) and HERPES ZOSTER (shingles) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported ).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced LETHARGY (lethargic), PARAESTHESIA (tingling in right leg), FEELING ABNORMAL (Just a weird feeling in my right leg) and RASH (rash developed on my leg right thigh buttocks). On 03-May-2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with FAMCICLOVIR  500MG three times a day . At the time of the report, LETHARGY (lethargic), PARAESTHESIA (tingling in right leg), FEELING ABNORMAL (Just a weird feeling in my right leg), RASH (rash developed on my leg right thigh buttocks) and HERPES ZOSTER (shingles) had not resolved. 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.
RIGHT FOOT SWELLING; CAN'T PUT WEIGHT ON IT WITHOUT  PAIN/FEEL LIKE CAN'T PUT WEIGHT ON FOOT; LUMP ON TOP OF RIGHT FOOT, SLIGHTLY TO THE SIDE; CAN'T WALK; RIGHT FOOT PAIN; FEVER; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient did not seek medical attention. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-JUN-2021, the subject experienced fever. On 22-JUN-2021, the subject experienced right foot swelling. On 22-JUN-2021, the subject experienced can't put weight on it without pain/feel like can't put weight on foot. On 22-JUN-2021, the subject experienced lump on top of right foot, slightly to the side. On 22-JUN-2021, the subject experienced can't walk. On 22-JUN-2021, the subject experienced right foot pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-JUN-2021, and had not recovered from right foot pain, right foot swelling, can't put weight on it without pain/feel like can't put weight on foot, lump on top of right foot, slightly to the side, and can't walk. This report was non-serious.
Around 1:00 pm started coughing blood,hour later had fever 104 had to be rushed to ER. I was hospitalized for 8 days. The physician diagnosed me with bacterial pneumonia. After being discharged from hospital had another CT scan found 3 in undefinable mass on right lung and nodules left lung. I have a appt scheduled to follow up with a Pulmonary specialist on 3/9.
Right Hand shaking; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Jan2022 10:00 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing), notes: Known allergies: Latex. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: Known allergies: Amoxicillin. The following information was reported: TREMOR (non-serious) with onset 28Jan2022 07:00, outcome "unknown", described as "Right Hand shaking". The event "right hand shaking" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of tremor.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Reporter seriousness of the events: non serious. The reporter was unable to locate or read the lot number details.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer. A 67-year-old female patient received PREVNAR 13, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient had temp of 101 F, was nauseous, sore arm pits and thinks lymph nodes inflamed. She was especially concerned about injection site which is hard, red and size of soft ball with a line of red going from injection site to arm pit to up over her breast. Caller wondering if these side effects especially the line of red are normal side effects and should she be concerned. States she called her doctor's office yesterday and told them she wasn't feeling well; the office said side effects were normal however they were unaware of the line of red at injection site. The outcome of the events was unknown. Information on the batch number has been requested.
High fever, swelling/redness at site, sleeplessness, foggy/hazy awareness, increased food sensitivity/GI troubles, lack of appetite.
Patient came for evaluation 6/19/17 with umbilicated vesicle widespread over body. Diagnosis given was Varicella.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, chills, fatigue Narrative:
Rash on the right side of my body; It was itchy then started burning.; Rash on the right side of my body, that started 1 wk after vaccination. It was itchy.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 31Mar2021 at 08:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (pcos). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 04:00, the patient experienced a rash on the right side of her body, that started 1 week after vaccination. It was itchy then started burning. It looked like her skin was burned. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event rash on the right side of patient's body, itchy and skin was burned was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist referring to a 59 year old female patient with type 2 diabetes mellitus and rheumatoid arthritis, who on 11-NOV-2013, was vaccinated with a dose of ZOSTAVAX, subcutaneously, (lot # J003808, expiration date 03-JUL-2014). Concomitant therapies included HUMALOG and methotrexate. None drug reactions/allergies were reported. Pharmacist reported that the patient was diagnosed with shingles by her primary physician on an unspecified date after 11-NOV-2013 and before 19-NOV-2013. Pharmacist reported that the patient was treated with valacyclovir. Pharmacist stated that the patient's episode of the shingles resolved on an unspecified date, therefore no VZVIP packet faxed as per pharmacist request. None laboratories test were performed. Additional information is not expected.
Lady had vaccine, was told it was Janssen but lot # is Moderna.  She got the vaccine, the night of the vaccine around 5:30 she got a raging headache (she does get reactions to most vaccines).  She took Tylenol and her arm did hurt.  The next day she was still really hurting, her headache was really, really bad, and it stayed until Sunday.  Then on Sunday she was ok.  On Monday when she went to work and her right arm went limp, and while she was walking her right leg gave way and almost fell, grabbed hold and steadied herself.  The raging headache/migraine came back and she started getting nauseous, her lower back hurt, her upper neck area hurt like somebody was pounding her neck.  Then she got diarrhea and really really tired on Monday and Tuesday and also had loss of appetite.  Then yesterday 4/13/201 she just had the headache and a sound in her ear, went to UC and got drops for it.  Her temperature was 96.5, and her normal is 98.7, and was told that she was really cold.  Her PB was really high and the doctor took it again but it was not as high, attributed it to anxiety.  Last night the lower abdomen pain started, feeling like she was getting her period which she has not had in over a year.  She saw a little blood on her panty liner, and was thinking she was going to have a period, but the pain is excruciating in her lower abdomen.   She has also taken Tylenol off and on for her symptoms, and feels like she is cramping.     She is having hot/cold flashes as well, and has not had these issues from menopause.
Pain at injection site, headache, fever (99.3 degrees), body aches, nausea  for approximately 24 hours
Severe Pain from legs toward thigh 1st dose suppered for 5 days on second dose On January 15 2021 severe painNext day  in the hip especially while walking and severe pain in the body worst in the back and both shoulder s and scapular site and severe next pain and stiff and chills called out from work since Monday January 18/2021 called Teladoc and if not improved and seen the primary care physician today for further evaluation
SERIOUSNESS: OTHER-MEDICALLY SIGNIFICANT. Initial report received on 03 December 2009 from a health care professional. A 17 month old female patient developed erythema multiforme from head to toe seven days after receiving all first time doses of DAPTACEL (lot number C3192AA) administered intramuscularly in the left thigh (the reported noted that the patient had received 3 previous doses of PENTACEL), FLUZONE No Preservative 2009-2010 (lot number U3266AA) administered intramuscularly in the right thigh, Influenza A (H1N1) 2009 Monovalent Vaccine- No Preservative (lot number UT023CA) administered intramuscularly in the left thigh, and MMR II (manufacturer Merck, lot number 0773Y) subcutaneously in the left arm on 23 November 2009. The patient was taking Amoxicillin at the time of vaccination. She completed the doses 48 hrs before the erythema multiforme appeared. A doctor's visit was reported, however a date was not specified. The recovery status was not provided. List of Documents held by Sender: none.  12/15/2009 PCP medical records received. Service dates 12/01/09 to 12/04/09. Assessment: Erythema multiforme. Parent states child has rash and fever. On amoxicillin. Was sucking on foam backing on stickers. Bruising on inner thighs. Presents with purple urticarial rash, started in groin area. Multiple target lesions with volaceous hue. Urine output diminished.
Swelling 2 inches below the injection site (not at the injection site and a doctor diagnosed it as a infection from the immunization)
Moderna COVID-19 vaccine EUA  2/09 19:00 - stiffness and pain in left arm 2/10 04:00 - fever, chills, fatigue, headache 2/10 08:00 - nausea
I woke up with congestion and started to develop a cough. I tested at home with a rapid test and tested positive. I went to an urgent care to receive antiviral medication. They gave me a five day pack of antiviral medication and they seem to work.
The pt developed febrile seizure on 02/20/2002 after getting vaccinations.
Patient stated feeling lightheaded, generalized pain, shaky and pale that day after vaccination. The next morning he stated his arm hurt severely. He stated his arm was red and swollen down to his elbow. He did not show me his arm because he had a long sleeve shirt on, but he did state it was still a little red today.
I had a cough, drainage in throat, and headache. By Thursday the cough got deeper, and I had dark colored mucus. I tested positive for COVID-19 on February 16, 2023. I spoke to my doctor, and she prescribed me Molnupiravir 200mg for 5 days. By the second day I started to feel better.