chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's husband, came to pharmacy and reported that his wife had reactions with the vaccine PNEUMOVAX 23 that patient recently got. He said patient first failed then he called ER to bring her to hospital, and found out her got very large swollen. He said Dr said pt got reaction from the PNEUMOVAX vaccine, then gave her something to reverse reactions. However, the next day pt got some kinds of infections after that, and stayed at hospital for 5 days. He said if needing more information, please call hospital.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient had no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with PNEUMOVAX 23 (lot number reported as H013847, expired date 15-MAR-2014) (dose, frequency and injection site were not reported) intramuscular injection on 24-OCT-2012. No other co-suspects were reported. There was no concomitant medication. On 26-OCT-2012 the patient was seen in the practice, complaining of discomfort, redness, and less heat and swelling of the arm, compared to the first two patients  (MARRS#1210USA014326 and 1210USA014757). Physician noted that the patient two days post-vaccination, as compared to one day post-vaccination for patients 1 and 2. The patient was recovering at the time of report. There was no laboratory diagnostics studies performed. The patient had an office visit for medical attention. Physician requests a lot check for the PNEUMOVAX 23. This is one of several reports received from the same source. Additional information has been requested.
Severe pain in jaw on left side at connection of upper and lower jaw bones. Specifically in the muscle.
Got the shot at 12:30 pm Saturday 3/27. Around 6 hours post-shot, soreness spread from the injection site across my back, into my neck, created a low headache, then went into my right arm and down both arms. Around 7 hours extreme fatigue set in. Chills hit at 9 hours. The headache became more generalized, extreme thirst, aches, shivering, and fatigue went on for exactly 24 hours. No appetite, rolling nausea (no vomiting), mental anxiety, cognitive fuzziness, sleepiness. Unable to read (short term memory and cognition), low attention for television. I never checked for fever. Around 6:30 the next evening (Sunday, 3/28), the symptoms retreated except for the fatigue and headache. Still a bit anorexic, but did eat lightly around 8 pm. Read, watched TV,  and slept better. Monday, March 29: I felt very fatigued and fuzzy-brained, but otherwise normal in the morning; the afternoon brought more energy, less headache. Tuesday, March 30: Everything  back to normal. Energy and clear thinking returned last.
sl fever gradually increasing w/a severe stiff neck; which lasted aobut a wk;
VACCINE WAS IN THE FREEZER FOR > 14 DAYS. IT SHOULD BE MOVED OUT TO THE REFRIGERATOR AFTER 14 DAYS.
No adverse effect reported; Inappropriate route of vaccination; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-AUG-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, frequency, lot# and expiration date not reported) intramuscularly, rather than subcutaneously (incorrect route of product administration), for prophylaxis. No adverse effects were reported.
Tremors, torticollis, pain, narcolepsy, memory loss, fatigue.
FIRM AREA NOTED AT SITE OF INJECTION MEASURING 2 INCHES IN DIAMETER. AREA ALSO NOTED TO BE RED, TENDER, AND WARM.
pt recvd vax 28JUL92 & on 9AUG92 pt presented to MD & was dx w/erythema multiforme;
This case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a infant patient who received ROTARIX (batch number A41CB432A, expiry date unknown). On an unknown date, the patient received ROTARIX. On an unknown date, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information received: ROTARIX diluent was given without powder. No adverse event reported. This case is one of the 3 cases reported by the same reporter for the same vaccine.
accidentally received Adacel injections from prefilled syringes that expired on 5/2/2019; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA196355 and 2019SA196388 same reporter.  This case involves patient of an unknown demographics who received expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] expiry date: 02-May-2019 (batch number, route and site of administration and vaccination date were unknown).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Expired vaccine used.  It was unknown whether 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.  Information on the batch number was requested.  Documents held by sender: none.
the patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.  On 21-MAY-2020, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot # S020241 with expiration date on 23-AUG-2020 (strength, dose, anatomical location or route of administration were not provided), for prophylaxis. The storage temperature of the vaccine was reported as 12.1 degrees Celsius (°C) for a time frame of 16 hours and 11 minutes. There was no previous temperature excursion. No product quality complaint (PQC) was involved. Digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Both Moderna doses caused flare of gout. Reaction to second dose was worse.  Joint pain, swelling, and redness. Treated with anti-inflammatories.
soreness @ injection site, 4 puffs of inhaler & advair diskus within 1st hour. No additional symptoms until 1:30 am where I was up all night. In severe systemic pain, fever, severe myo aches, some mild wheezing resolved with inhalers & migraine. Intermittent stuffy nose & sore throat but it goes away. Pain level 10. I can barely move. Dizzy & drinking water & taking otc pain meds. Unable to work or daily function
Headache, Arthralgia, Fever, chills, injection site pain Narrative:
By 5pm, chills started with a severe headache and body aches. Tylenol and Advil used together did nothing to relieve the crushing pain in my head. I continued to chill and feel completely deflated through today. The intense sore throat and congestion started yesterday morning.  I had a COVID test done because I feel so ill. It was negative. I have no energy and can hardly get out of bed. I am rarely sick and in great health until the time of this vaccine.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose, route and lot number unknown). On an unknown date, the patient experienced injection site reactions following the administration of ZOSTAVAX. The patient developed redness, warmth, swelling and pruritus. The patient also developed a rash at the injection site. The outcome of the events was unknown. The patient has sought medical attention via office visit. Nurse was offered the VZVIP packet, which she declined. This is one of the two reports from the same reporter.  Additional information has been requested.
A report has been received from a Health Professional via medical representative concerning a 4 year old female patient, who received Nasal FLUMIST Quadrivalent. Once/Single administration. FLUMIST Quadrivalent was started on 09-NOV-2015. The patient experienced vomiting, fever and congestion which started on 10-NOV-2015. The outcome of the events of vomiting, fever and congestion were unknown. The report was considered to be non-serious.
I had the injection and I dont know exactly how long after, but i started to experience a very mild itch specific to the injection shot. Its not there ALL the time but most of the time, just a very mild itch where the shot was. A small little scab pops up at the injection site every so often. I had a routine dermatologist appointment and asked them to look at it, because of my experience with covid arm with a previous vaccine. She wasn't worried about it and gave me a prescription anti-itch cream (not hydrocortisone) but it didn't work.
pt recvd vax; pt felt sleepy & lethargic ; t104.1; stiffened eye rolled back in head; pt given APAP & iv fluids; pt had macupapular rash;
Vaccine administered after temperature excursion; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Severe shaking and chills in the evening. Woke up with headache in the morning.
Flush feeling; Strange smell (medicine-like); Slightly elevated heart rate; Slight weakness; This is a spontaneous report from a non-contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (at the age of 63-year-old) (Lot Number: EN6203) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included none. The patient did not have any known allergies. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced flush feeling, strange smell (medicine-like), slightly elevated heart rate, slight weakness on 03Mar2021 09:45. The patient did not receive any treatment for the events. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
maculopapular rash; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 28Mar2021 at 10:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 the patient experienced maculopapular rash which persisting for over 10 days. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event maculopapular rash was not recovered.  No follow-up attempts are needed. No further information is expected.
Pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient (gravida 2, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Premature birth (The patient had IVF for twin pregnancy in 2018 and delivered at 35 weeks) on 13-Nov-2018, Vanishing twin syndrome (During first trimester) in 2020 and In vitro fertilization (Previous twin pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 08-May-2021. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-third week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.  The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy.
One day after vaccination my baby started to get a fever and had typical ill symptoms such as drowsiness, lack of appetite, fatigue and high temperature. He never went back to full normal until on 6/3/2019, 11 days after the MMR Vaccine he got a febrile seizure! He stopped breathing, turned greyish blue. I called immediately 911, the ambulance came and he got transported via ambulance to the Hospital. He is not himself since. Today is 6/4/2019 and he is still running fevers and i am trying to keep the fever down via suppositories. He rejexts any type of oral fever reducer.
Patient stated that the day after receiving the flu shot, she started experiencing stabbing pain in the back of right neck and ear and tenderness on the right side of the top of her head. She has been taking ibuprofen for the pain and was recommended by a pharmacist over the phone to take ibuprofen and CLARITIN. The tenderness went away on 10/3/13, but still feels the stabbing pain.
About 10 minutes after she received the vaccine she reported to me that she had felt some pain in one of her ears.  She said it was getting better but she just wanted to tell me about it in case it was caused by the vaccine.  She also said she had been clenching her jaw.
05:04PM Pt c/o nausea, lightheaded, for about 1-2 minutes.  BP 92/62, SPO2: 98%, HR: 77  Pt took some water. 05:18PM Pt states she feels better. BP: 140/85.  Pt left the facility asymptomatic.
over 8 weeks since first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 8 weeks since first dose) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 8 weeks since first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 8 weeks since first dose) outcome was unknown.        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.   No concomitant medication details were provided.  No treatment information was mentioned.  Patient was also stated that she did not have any symptoms after the first dose.
This is a spontaneous report from a contactable registered nurse via a company representative. A 18-year-old female patient of an unspecified ethnicity received first dose of TRUMENBA on 19Aug2015 at 0.5 ml, single for prevention of meningitis. The patient medical history and concomitant medications. On an unknown date in Aug2015 the patient developed hives around injection site and pain at injection site. Patient was treated with BENADRYL. Event was "a reaction from vaccine, may be a slight allergy to sensitivity". The patient recovered on an unknown date in Aug2015. Follow-up (02OCT2015): Follow-up attempts completed. No further information expected.
I have a patient who came in for her Menquadfi and after the fact one of the nurses noted that the lot number documented was for Tdap withno adverse event; Initial information received on 29-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient who experienced i have a patient who came in for her menquadfi and after the fact one of the nurses noted that the lot number documented was for tdap with no adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE (strength, dose, route, lot number and administration site: unknown) for Prophylactic vaccination (Immunisation).  Reportedly patient who came in for her Menquadfi and after the fact one of the nurses noted that the lot number documented was for Tdap (wrong product administered) (event onset and latency: unknown). The nurse that gave it cant be 100 percentage sure if this was the wrong shot given or the right shot and the wrong lot number aren't right near each other.  Action taken: not applicable  Outcome: Unknown   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 the 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.
vaccine was stored in fridge beyond 30 days when administered to pt; follow up with pt; pt reported no adverse effects; advised repeating dosage
onset of dizziness & inc BP 30 mins p/shot; 210PM BP 144/100, P88; 215PM BP 140/90, P92; 220PM back to work advised to f/u w/BP w/MD will eat in 2 hrs to stabilize diabetic blood sugar;
Severe dizziness; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3247), via an unspecified route of administration in the left arm on 18Jan2021 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 18Jan2021 14:00, the patient experienced severe dizziness. No treatment was received for the adverse event. Outcome of the event was recovered on 19Jan2021 02:00.
Three days after getting the shot,  a sudden and continuous ringing in both ears began.    Sought treatment from an Audiologist to no effect.   Still have the ringing in my ears to this day.
I received the vaccination on Thursday, February 25, 2021  My arm was slightly sore, but nothing terrible.  However, on Friday, March 5, my arm began to itch.  Originally, I thought it was a mosquito bite.  I began to suspect it was the vaccine when my arm became red and the swelling was much larger than a typical insect bite.  The itching, redness, and swelling went down after a couple of days and began turning into a dry rash.  However, last night, March 10, it began to itch again and the swelling and redness are even more pronounced than it was before.
After Tdap on 9/27/11 pt. returned to office c/o soreness and edema, Lt. neck pain with adenopathy Lt. shoulder (edema & arm) 2 1/2x2" also c/o Lt jaw pain.
Twenty-four to forty-eight hours following vaccination with DTaP, left upper arm became painful, red, swollen and no septenic symptoms. Pt given pediopred and Benadryl (5 day course).
Narrative: Pt did have hx of allergies and carried epi pen. We did consult provider, who ordered 50 mg diphenhydramine 15 min prior to vaccine administration. Approx 20 minutes post vaccine pt reported "itchy, swollen tongue" and significant swelling/redness was visualized. Pt taken to nurse exam room, 0.3 mg epinephrine administered, VS obtained, 02 NC applied, and  911 called for transport to hospital for further observation. Pt stable at time of transfer.
~ 14 hours post vaccination, developed intense symptoms: headache, fever (101.3), intense chills, joint pain, all over body aches, fatigue and nausea.  All lasted for 48 hours; began resolving slowly.  Missed 2 days work as a nurse manager, mostly due to joint pain and nausea.  No local reaction present, no rash, no lymph involvment or diarrhea.
Experience numbness, tingling, loss of feeling in hands when fingers are bent. Occurs throughout day and night without any apparent patterns.
A few days after receiving the vaccine, I started feeling extremely fatigued and I noticed I had some bumps on my body.  I went to the doctor and it was determined I was having a herpes outbreak which I haven't had in 8 yrs. I was prescribed Valacyclovir for 7 days.
woke up with face, neck, covered with bright red spots that did not itch or ooze.  Spots gradually continued down upper torso, the lower torso the next 3 days. Spots a pinhead size and could be felt. Each one (raised). In three days they started to slowly fade and disappeared. No fever or discomfort appeared.
REDNESS AND ITCHING AT INJECTION SITE. HIVES FORMED 9/25/15. ITCHING ON LEFT SIDE OF BODY.
Pt called office to report a strong metallic taste in mouth onset 2/27/21 at 3am. It has persisted through present.
Fever,  diarrhea,  nausea,  vomiting,  body aches
Starting having left arm/shoulder/bicep pain.   After injection site pain which seemed to never go away, it developed into shoulder problem.  Orthopedic I saw said he heard of this happening after Shingrix. MRI was negative.  Went for PT for few months until  it was better.    Then few months later pain returned, tried doing exercises on my own, didn?t work, got cortisone shot that helped.. Went for PT again in 2021 until insurance wouldn?t pay anymore.  Now pain is more in my bicep and I?m seeing an acupuncturist to see if that will help.