chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 31/Oct/2005 from a health care professional. A 53-year-old patient had received an intra-muscular injection of DECAVAC, lot number U1597CA in the left deltoid on 12/oct/2005. At an unspecified time later, the patient developed redness, swelling, itching, nodule and pain at the injection site. Per the reporter, it is unknown if the patient recovered from these events. The reporter of this case is the same as for cases 2005-02253, 2005-02254, 2005-02255, 2005-02256.
Left arm of injection site extremely painful. Little to no movement. Painful to the touch. Severe headache/Migraine since the day of vaccine injection.
4 x 2 cm red, mild swelling, tender - left lateral upper arms appeared w/in 24 hrs of vaccine administration.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored PNEUMOVAX 23 (dose, lot # and route of administration were not reported). Patients were also vaccinated with improperly stored Tetanus-Diphtheria vaccine (TD). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
12:15pm pt. was seen sitting in wheelchair with EMT and dad at his side.  EMT stated pt. c/o dizziness, nausea and blurred vision after taking Pfizer COVID-19 vaccine.  At 12:13 vital signs taken by EMT staff.  HR 74, BP 104/70, O2Sat 99%.  12:20pm pt. denies any pain or discomfort.  12:30pm pt. left vaccine site to go home via wheel chair.  EMT and dat at his dice with no signs of acute distress.
Chills starting at 6:00 pm for 3 hours,  severe ache in hips, shooting pain in knees  Ended at 4:00 am.  Next day tired from little sleep.  2nd night shooting pain in knees x4  No other reaction after that.
patient suffered a severe desaturation that resulted in a PEA arrest. CPR performed and ROSC achieved but patient ultimately was made DNR and patient again had a severe desaturation that resulted in asystole.
3 weeks post second moderna shot started to feel a fullness, numbing sensation in left ear. No history of ear issues. Since then I've had one episode of vertigo and ear sensation everyday for almost 4 months now post second shot. Starting to get tinnitus.
Intense shoulder pain for several weeks. First week I was prescribed muscle relaxers and Ibuprofen. This had no impact on pain. Then I received an X-ray, which revealed to structural damage. I then was prescribed prednisone. After a week of prednisone, the pain had started to subside, but was still weak and pain when trying to use the arm. I then went to see a Orthopedic doctor and had an MRI. MRI showed inflammation, but no structural damage. Doctor prescribed 6 weeks of PT, 3 time a week. Weakness still impacting daily life after 3 weeks of therapy.
10/12/2011 patient had an influenza injection. Patient began taking LIPOFEN 150mg capsules. Patient's tongue began to swell, and she had difficulty breathing. Swollen tongue and difficulty breathing resolved later that day, after prednisone was administered. Patient temporarily stopped LIPOFEN therapy. 10/20/2011 patient reported to medical doctor: After a couple of days she resumed taking LIPOFEN and she has not has any adverse side effects. Patient remains on LIPOFEN therapy. Medical Doctor's Opinion: Events are not related to LIPOFEN. Events are serious. No additional information is expected.
I contracted COVID-19 on 10/18/2022 with symptoms of sore throat, congestion, headache, body aches, cough, brain fog, fever of 103, and fatigue. I was prescribed on PAXLOVID on 10/21/2022. My symptoms began to resolve after day 8, but I am not fully recovered yet. I am still experiencing slight cough, congestion, and mild brain fog.
Patient requested as per md instructions and received PREVNAR 13. Called back to inform she received same vaccine 12/16.
received / a dose / that had expired on 08-Aug-2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X2XJ7, expiry date 8th August 2021) for prophylaxis.   On 17th August 2021, the patient received Boostrix. On 17th August 2021, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: On 17th August 2021, patient received a dose of Boostrix, which was already expired on 8th August 2021. The reporter consented to follow up.
My pregnancy up until that point was normal with no complications. I had to be induced on 1/6/2022 I had low fluid so then I went into labor and delivered my daughter and immediately started coughing and had chest pain. Everyone thought it was my asthma or I had Covid. They discharged me on the 9th and I ended up going to the ER on the 10th.  At the ER they did a CT scan and found a pulmonary embolism in my right lower lung. I was admitted into the hospital and discharged on the 12th of January and placed on blood thinners, which I'm still on. Once I'm done breast feeding they will do a follow-up CT scan to confirm the blot clot is gone and there are no others.
On 12/30/2020 at 1000 she developed body aches in her shoulders and lower back. Reports having stiffness in the left hip area. Denies any fevers. Noted pressure in her head and discomfort in her left ear. These were s/s similar to when she was diagnosed with Covid on Nov. 17. Reports that since Covid her taste and smell has not come back fully but wondered if it was a little worse. She ended up completing her work day after taking Tylenol x1. At end of work day she reports feeling like "she had Covid again". Due to s/s she was not able to work on 12/31/2020.  On 01/04/2020 she presents to work with a softball size area of redness, feverish to touch, hard to touch in left deltoid area where injection was given. She reports being afebrile or any other s/s at this time.  She reports that after the injection her arm was sore but did not notice until the 01/01/2021 a hardened area in the left deltoid area. She was instructed to contact her PCP due to her concerns for taking the 2nd Covid vaccination with understanding voiced.
Pfizer  vaccine  given as #2 vaccine with patient already having Moderna as #1 vaccine. Patient denies any adverse reaction. No signs or symptoms noted.
C/o cellulitis of the left arm at the site of injection. --> Treated with KEFLEX antibiotic for infection.
Pt had received their second dose of pediatric Pfizer on 12/27/21 . And based on grace period, pt received their booster dose one day too early.
Towards the afternoon on day 1, arm soreness. BY the evening, body aches. On Day 2, sever body aches, reaching a body temp of 100.7. Also redness around injection site. Day 3, temp subside to 99.5 and then continued to lower. Body aches subsided towards the middle of the day. Noticed a red rash with red dots on neck and chest. Redness at injection site is still there. Took benedryl at night. Day 4 redness around arm is less but still sore. Rash on neck seems to be more splotchy and less red dots.
Extremely high fever and chills (peaked at 104.2). Severe arm pain in injection-site arm.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Seasonal Influenza vaccine. Co-suspect products included ADVAIR DISKUS inhalation powder for drug use for unknown indication. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose and ADVAIR DISKUS 250/50 ug at an unknown dose and frequency. On an unknown date, the dose was changed to an unknown dose and frequency. In December 2016, an unknown time after receiving Seasonal Influenza vaccine and not applicable after starting ADVAIR DISKUS, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the patient experienced pneumonia (serious criteria GSK medically significant), osteoporosis, heart disorder, bronchitis and asthma. The patient was treated with Albuterol. ADVAIR DISKUS was discontinued (Dechallenge was unknown). Rechallenge with ADVAIR DISKUS was unknown. On an unknown date, the outcome of the vaccination failure, pneumonia, osteoporosis, influenza, heart disorder, bronchitis and asthma were unknown. It was unknown if the reporter considered the vaccination failure, influenza, bronchitis and asthma to be related to Seasonal Influenza vaccine. It was unknown if the reporter considered the pneumonia, osteoporosis and heart disorder to be related to ADVAIR DISKUS. Additional details were provided as follows: The age at vaccination was not reported. The patient had been receiving ADVAIR 100/50 and also 250/50 since the mid 1990's. Over time the patient have developed an electrical heart problem and last year she was diagnosed with osteoporosis. It had worked well for her most of the time, but she have had bouts of pneumonia several times and resorted to using her home nebulizer with Albuterol. The patient voluntarily decided to quit using ADVAIR about a month before reporting date (was on the 100) and since had the flu (even though she had received the flu shot) and eventually bronchitis. At the reporting time, the patient was at a point where she cannot differentiate between if she had bronchitis or asthma. The patient's pulmonologist cannot see her until 14th February 2017. The patient inquired if she had used ADVAIR for too long. The patient would like to be armed with some information before she have her appointment with pulmonologist doctor. This case was considered suspected vaccination failure for influenza vaccine since the time to onset of the events and confirmatory lab test details were not provided.
they administered a 16 year old patient with Flublok/no AE; Initial information received on 30-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient (60.317 kg) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Pregnancy status: negative.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Immunisation and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  On 30-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot 2FAA1953, expiry date 30-Jun-2010 via intramuscular route in the left arm.  It was a case of actual medication error due to Inappropriate age at vaccine administration.  It was not reported whether the patient experienced 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.
This spontaneous report has been received from a practice manager referring to a patient of unknown age. Information about concomitant medications, concurrent conditions, and medical history was not provided. On 02-AUG-2018, the patient were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, route of administration were unknown; lot # R006746 and expiration date 19-NOV-2020) for prophylaxis. No adverse effects were reported. The reporter reported multiple temperature excursions over the past year and a half found during an audit. The excursion temperature in 08-NOV-2017, 16-NOV-2017; 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 was 47 degree Celsius for max 15 hours. And in 07-DEC-2017 was 50 degree Celsius for max 8.75 hours. Data logger was not involved. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959.
Patient started to feel weakness and felt "funny" approximately 1 hour after injection.  Patient reported in addition to feelings of soreness, tiredness, and achiness, general weakness. A little over 48 hours later, patient presented to the ED with tingling and numbness. 72 hours later, patient admitted to the hospital with more tingling and numbness including arms, legs, hands, fingers, and face. Non-stop chin trembling occurred. Patient had MRI and spinal tap done with normal results. Neurology treating as Guillain Barre Syndrome due to symptoms. Patient's heart rate was elevated. Immunoglobulin therapy started approximately 96 hours after injection received. Heart rate returned to normal with first therapy treatment. Neurology saw progression of symptoms stopped with the therapy.
injection site soreness; severe pain at injection site; joint discomfort; This spontaneous report was received from a physician via company representative refers to a 39 year old female patient. The patient's concurrent conditions, concurrent conditions and concomitant medications were not reported. On 29-MAY-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1, intramuscular for prophylaxis. On 29-MAY-2019, the patient experienced soreness at the injection site. On MAY-2019(reported as over the next few days), the patient developed severe pain at injection as well as joint discomfort. There was no treatment rendered for the event. Lab tests were not performed. The outcome of the events was reported as not recovered/not resolved. The causality was not reported. The patient sought medical attention.
Patient had a silver dollar sized bright red rash at site of injection.  It appeared 48 hours after Zostavax administered.  It was also warm to the touch, however was painless.  She called her physician and was instructed to keep an eye on it.  She also contacted the pharmacy so we could report it.
mom states that on or around 13MAR97 pt had an elevated temp between 101 & 102;mom gave pt Ibuprofen;later on mom noticed red rash on upper body;
Mom telephone to say that pt broke out in hives on his legs (waist down) on the first day, chest area on second day, arms on third day, and to hands by fourth day. She treated him at home with Benadryl but did not contact an MD. She denies son having fever or other symptoms.
Fatigue, headache, overall crappy feeling.  Lasted for about 4 - 5 days.  I had a little fever but not bad.  I felt intensely crappy on a scale of 1 - 10, I was about a 5.  The last vaccine was worse than the others.  After the vaccine, I had joint pain, low grade fever, fatigue, headache, and an overall crappy feeling.  On a scale of 1 - 10 I was about a 7 right after the vaccine.  Having seconds thoughts about getting any future vaccines.
Patient experienced syncope on the night of 1/24, hours after receiving the second dose of the Pfizer COVID vaccination. Patient reported feeling "hot and clammy", claimed her blood pressure dropped, and she fainted. She presented to the ER and was released the same night. Upon follow-up on 1/25 patient reports she has recovered from her fainting episode but feels tired, achy, and generally unwell; these side effects are to be expected following the 2nd dose of the Pfizer COVID vaccine.
patient only received the liquid part of the pentacel vaccine and not the powder part with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 22 months old female patient who only received the liquid part of the pentacel vaccine and not the powder part with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Jul-2023, the patient received 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection lot UJ805AA, expiry date: 17-Feb-2024 via intramuscular route at unknown administration site for immunization (strength: unknown), patient only received the liquid part of the pentacel vaccine and not the powder part with no reported adverse event (single component of a two-component product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event single component of a two-component product administered.   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.
Red bump rash in left armpit chest and back. Dull ache in left shoulder deltoid
After the vaccine 5 hours later I had trouble breathing, diarrhea weakness. I was also told that I was allergic to the vaccine from the ER doctor. I am having a heart monitor done on me, my heart monitor will be put on August 4, 2021.
neck pain; back pain; waterly diaarrhea; stomach upset; cramps; bloating; injection site warm; vaccination site pain and warm; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), BACK PAIN (back pain), DIARRHOEA (waterly diaarrhea), ABDOMINAL DISCOMFORT (stomach upset) and MUSCLE SPASMS (cramps) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Irritable bowel syndrome.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced NECK PAIN (neck pain), BACK PAIN (back pain), DIARRHOEA (waterly diaarrhea), ABDOMINAL DISCOMFORT (stomach upset), MUSCLE SPASMS (cramps), ABDOMINAL DISTENSION (bloating), INJECTION SITE WARMTH (injection site warm), VACCINATION SITE PAIN (vaccination site pain and warm), CHILLS (chills) and PYREXIA (fever). On 12-Apr-2021, NECK PAIN (neck pain), BACK PAIN (back pain), DIARRHOEA (waterly diaarrhea), ABDOMINAL DISCOMFORT (stomach upset), MUSCLE SPASMS (cramps), ABDOMINAL DISTENSION (bloating), INJECTION SITE WARMTH (injection site warm), VACCINATION SITE PAIN (vaccination site pain and warm), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.   This case was linked to MOD-2021-076346 (E2B Linked Report).; Sender's Comments:  MOD-2021-076346:dose 1
COVID-19 Lot # FE3590 Vial PAA165959 Exp 2/22 was placed in the freezer after we received it.  It should have been pulled out of the freezer on 10/19/21 at 12:00PM according to the storage guidelines and placed in the refrigerator for 31 days.  Our staff did not pull the vial out of the freezer on this date. The staff noticed the date this morning, November 2, 2022 at 0830.  There were 22 patients who received the COVID vaccination during this time frame.  The vials were pulled out of the freezer, thawed, and diluted per instructions during 10/19/21 through November 1, 2021. There are 21 vials that were not used and have been set aside to waste.
Information has been received from a nurse concerning a 12 year old female who on 22-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 658287/1173U). Concomitant therapy that day included Gardasil, Hepatitis A vaccine (inactive) (MSD), Fluzone (manufacturer unknown) Menactra (manufacturer unknown). On 24-OCT-2007, the "patient reported redness surrounding the injection site approximately 48 hours after receiving the vaccination." No further information was given. The outcome was reported as recovered on 26-OCT-2007. There was no product quality complaint. Additional information has been requested.
Narrative:  Patient was 16 (currently 51) when he developed GBS after administration of influenza vaccine. Reported originally 5/25/2016, notes added on 3/24/2017, where patient history was noted of age, and 3 week duration in hospital. History was reported most recently on 4/11/2022.
Fever at 100.3F Stiff and weak muscles-severe (had trouble walking in home) Fatigue-severe (struggled to stay awake at work) Chills Muscle aches-severe Developed a knot on the arm Itching at injection for 6 days Constant thirst (I was drinking more water than usual and could not seem to feel hydrated no matter how much I drank)
2 days after receiving the Tdap vaccine she woke up with a lot of painin her left arm and and was unable to lift her arm.  This condition  has persisted and the pain during the day is 4/10 and she is awaken at night with a 10/10  that is only relieved by pain medication.  Currently being treated by a neurologist.
Vaccinated on 5/7/07 right arm from shoulder to elbow swollen and hand starting at 5/8/07 evening. Icing arm still swollen 5/10/07 swelling went down - didn't take her to the doctor.
Information has been received from a nurse concerning a 49 year old female patient with immunosupression who on 11-NOV-2008 was vaccinated with a dose of PNEUMOVAX (lot # not provided) and was vaccinated on the same day and on the same arm with a dose of (FLUVIRIN). On 11-NOV-2008, six hour post vaccination, the patient experienced nausea, fever, vomiting, soreness of arm and a developed a 4 by 3 cm ecchymosis with no erythema in upper right arm. It was reported that the patient sought medical attention at a different clinic due to the reaction she was experiencing with the vaccination, and was told in the urgent care clinic that the PNEUMOVAX vaccine and the FLUVIRIN should have been given in different arms. Nurse reported that the patient might seek legal action against the physician's office who gave the vaccinations. Additional information has been requested.
Upper arm swelled with hives and arm pain for 1 wk, cotton mouth / puffy mouth. Chest discomfort. Low grade fever.  Fatigue. Headache.  For a week to 10 days Joints  in hands, feet , elbows, knees swelled for  three weeks with pain  and decreased mobility.
Pt given 0.5cc COVID #2 injection (Moderna), was waiting in patient area for 30 minutes due to h/o other reactions previously. 20 minutes after injection, pt remarked that she felt hot.  Brought back to resp clinic, wasn't having any SOB or CP, didn't appear very flushed.  Was shaking. Pulse ox applied, O2 stayed between 98 & 99% RA.  HR was initially in high 80's (pt on 50mg metoprolol QD), climbed up to 109. BP (lg cuff, rt arm) was 144/91.  Pt became nauseated, vomited phlegm.  Did not feel presyncope.  Ice applied to back of neck. No redness at injection site.  Heart exam: no murmurs or irregular heartbeat; lungs CTA throughout, no stridor or wheezing. Pt remarked that the heart racing, shakiness & heat felt like previous times when she was given racemic epi for reactions.  Was monitored for 30 minutes, HR stabilized in low 80's, sensation of heat dissipated.  Was allowed to leave 50 minutes after vaccination given, and advised to call for EMT if symptoms came back.  She expressed understanding, and was told to NOT drive herself home (family member was with her).