chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received from a consumer who is the parent on 03 February 2014. A 3 year old female patient, with a medical history of eczema, received FLUZONE QIV, batch U4769AA, on 10 January 2014, route and site of administration were not reported. The reporter denied that the patient had an illness at the time of vaccination or any other vaccinations with 4 weeks of FLUZONE QIV. A couple of days later, the patient experienced a low grade fever. On 18 January 2014, the patient presented with bleeding from the nose, mouth and had bruises and petechiae. Platelet count was 1000 units on an unreported date. The patient was taken to the emergency room and was hospitalized for two days, dates not reported. The patient was treated with IG. The reporter stated it was autoimmune origin. On an unreported date, the platelet level was 33,000. The patient was followed by hematology. No other medications were given. The patient outcome was not recovered. Follow-up information was received from the healthcare professional on 27 March 2014, which included laboratory reports and the patient's complete vaccination record. Abnormal laboratory findings on 17 February 2014 included the following: red blood cell count 3.85 mill/mol; hemoglobin 11.0 g/dL and hematocrit 32.6%. Additionally, platelet count was 144 thous/mcL. Outcome was not reported. Follow-up information was received on 02 May 2014 from a healthcare professional. The patient's birth weight was 7 pounds and she has one brother and one sister. The patient's platelet count of 1,000 was detected on 18 January 2014 (previously was not reported). The patient no longer receives treatment. Outcome was recovered. Documents held by sender: office records, including complete vaccination record and laboratory report.
Pfizer COVID-19 Vaccine EUA.  Patient presented to ED with complaints of pruritus, lip swelling, rash to neck,shortness of breath, dry throat, right side of throat swelling and pain. Patient was treated with methylprednisolone 125 mg IV, Diphenhydramine 25 mg IV, Famotidine 20 mg IV. Epinephrine 0.5 mg IM was administered 17 minutes after other medications.
This case was reported by a pharmacist via claims management company and described the occurrence of adverse event(s) in a male subject of unspecified age who was vaccinated with FLULAVAL TETRA (GlaxoSmithKline). On 25 January 2014 the subject received a dose of FLULAVAL (unknown details). In January 2014, within days of vaccination with FLULAVAL, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
Pfizer-BioNTech COVID-19 Vaccine EUA Localized inflammation, erythema, induration, swelling, pain, itching. Began on post-vaccine day one and continues into post-vaccine day two with less pain and slight reduction in swelling. Iced it on day one with some relief of swelling and pain.
Redness, itchiness to immnization site begining 7 days after immunization.  No pain, no swelling, no fever.
some redness & swelling to rt leg vax site since 3MAR, 10MAR95 whitehead formed twenty five cent hard area, mom got small amt of pus out; MD advised hot compress BID, bacitracin; RTC if further problems;
received vaccine at external site 5/3/21 Had onset of Right facial weakness, diagnosis of Bell's Palsy on 5/23/21
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination. Concurrent medical conditions included HIV disease (All of them were under treatment for this illness). Concomitant products included Insulin Glargine (Toujeo), Benztropine [Benzatropine], Mirtazapine, Ritonavir, Amlodipine, Darunavir Ethanolate (Prezista), Dolutegravir Sodium (Tivicay) And Rosuvastatin Calcium (Crestor) for an unknown indication. On 01-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had no known allergy. It was reported that the patient was administered Moderna COVD-19 Vaccine which was stored in the fridge for more than 30 days. Patients treatment details were not known to the reporter, as reporter did not know if any adverse events had occurred.
LEG CRAMPING; HEADACHE; SPORADIC NERVE PAIN/ HEATING SENSATION IN ARM NECK AND FACE; FELT TINGLING SENSATION IN HER ARM, NECK AND FACE/PRICKLING AND TINGLING IN BOTH LEG; NECK STIFF; FACE FLUSHING; PAIN IN LEGS; This spontaneous report received from a consumer concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced sporadic nerve pain/ heating sensation in arm neck and face. On 08-APR-2021, the subject experienced felt tingling sensation in her arm, neck and face/prickling and tingling in both leg. On 08-APR-2021, the subject experienced neck stiff. On 08-APR-2021, the subject experienced face flushing. On 08-APR-2021, the subject experienced pain in legs. On 08-APR-2021, the subject experienced headache. On 15-APR-2021, Laboratory data included: Blood test (NR: not provided) Not reported, CAT scan (NR: not provided) not reported, and EKG (NR: not provided) not reported. On an unspecified date, the subject experienced leg cramping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face flushing, and headache on 10-APR-2021, had not recovered from felt tingling sensation in her arm, neck and face/prickling and tingling in both leg, and pain in legs, and the outcome of sporadic nerve pain/ heating sensation in arm neck and face, neck stiff and leg cramping was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required per standard procedure as the case assessed as non-serious.
Frozen shoulder - developed on Nov 7, 2022 and although it's improved, it has not resolved. Spent months in physical therapy, received steroid shot, and it still has not fully resolved.
Symptoms started the night of the vaccine, symptoms included headache, soreness in arm, itching, yellow circle size of dime at injection site, red patch that goes down arm about 3-4 inches down, and chills.Has not tried seeing doctor or self medicate
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 29-JAN-2013 the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date not reported) intramuscularly into the hip muscle. On 28-FEB-2013 the patient was vaccinated with dose 2, GARDASIL (lot#, expiration date not reported) intramuscularly into the hip muscle. No known adverse events. Additional information has been requested.
Fatigue, body ache and fever begin to set in. High discomfort in passing urine. Fever peaked at 11:30 pm at 102.1 and began to subside at at 1:30 AM. Extreme joint pain continued through most of the night, but painful urination subsided around 1:30 AM. Generally achey for the day of 09/19/2012. Temperature returns to normal by 3:00 PM on the 19th.  Primary Physician runs viral test but test result is negative. Injection site is still mildly itchy on this date 12/24/2012.
TMJ dysfuntion; intense pain when trying to eat etc; I woke up with intense pain on my right side TMJ; limited movement; pain in the ear; popping sound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2021 17:00 (Lot number: 330368D) as dose 1 , single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NAPROXEN. The following information was reported: TEMPOROMANDIBULAR JOINT SYNDROME (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "TMJ dysfuntion"; EATING DISORDER (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "intense pain when trying to eat etc"; ARTHRALGIA (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "I woke up with intense pain on my right side TMJ"; MOVEMENT DISORDER (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "limited movement"; EAR PAIN (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "pain in the ear"; EAR DISORDER (non-serious) with onset 02Jan2022 07:45, outcome "not recovered", described as "popping sound". Therapeutic measures were not taken as a result of temporomandibular joint syndrome, eating disorder, arthralgia, movement disorder, ear pain, ear disorder.  Additional information: The patient was not diagnosed with COVID-19 prior and since the vaccine. The patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
pt recv vax 23JAN97 & 16MAY97 pt devel chickenpox w/50-60 lesions described as vesicular on an erythematous base, an URI & t100;25MAY97 pt recovered;
Fever of 104.5 for 18 hours, chills, severe muscles cramps, body aches, headache
A report was received from a health care professional concerning a 22 year old female vaccinee who inadvertently administered last years Fluvirin formulation on 24Oct02. On 24Oct02, the vaccinee inadvertently administered last year's Fluvirin vaccine. No adverse event was reported to be associated with the incident. There was insufficient information to determine the reporters causality assessment. Ref: PJP200200654; PJP200200652;PJP200200650; PJP200200653.
Since receiving the vaccine, I have experienced four outbreaks of herpes simplex (cold sores).  Prior to those, it had been nearly two years since the previous outbreak.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191; 2019SA267208; 2019SA267209; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves (an elderly) male patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020 via intramuscular route in the left deltoid on an unspecified date which was 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant vaccine was Pneumococcal Conjugate Vaccine 13.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Documents held by sender: none.
Shakes for one day, next day started with red skin, face in particular. By 3 (10/25) face was very red. Red and swollen until Friday/Saturday. Blistering on Sunday, peeling on Monday. Mild nausea.
5x4 inch red area around injection site. Very warm and itchy. Used ice on are. Started 2 days after shot, 1/23/2021, itching stopped 3/1/2021, red mark went away 3/5/2021
Pt presented to ED at the recommendation of the PCP for low hemoglobin where he reported having increased generalized weakness for the past month, dyspnea on exertion, occasional lightheadedness.  On arrival to ED was found to be hypotensive, with elevated WBC count, mildly elevated lactic acid level, and anemic at Hgb 7.5.  An incidental finding of a positive COVID-19 nasal swab was found despite receiving Pfizer COVID vaccinations on 1/30/21 and 2/20/21.  Pt admitted for additional management of sepsis, hypotension potentially secondary to COVID-19 infection and/or RLL developing pneumonia.  Pt currently still hospitalized with worsening acute respiratory failure due to COVID and acute pulmonary embolism.
Patient reports right side tongue swelling resulting in blue/black color as well as a lump and bruising in her inner right forearm. She is a nurse so she began advil and benadryl and proceeded to the ER at Hospital. They evaluated her but did not do any other treatment or tests and advised her to follow up with her PCP for complete blood work, to continue OTC medications as needed, and to contact the administration site.
subsequently experienced ''bad pain" and swelling in her shoulder muscles two days later on 14-NOV-2019; subsequently experienced ''bad pain" and swelling in her shoulder muscles two days later on 14-NOV-2019; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's concomitant therapy included an unspecified "progestin only pill". And the patient doesn't referred allergies or pertinent medical history.  On 12-NOV-2019, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection in the left shoulder, for prophylaxis (dosage schedule, route, lot number, and expiration date were not reported).         On 14-NOV-2019, the patient experienced ''bad pain" (injection site pain) and swelling in her shoulder muscles (injection site swelling). The swelling had persisted for two and half weeks. The patient visited the physician for medical attention, and she didn't received treatment for the events. Also, no laboratory diagnostics or studies were performed.   The outcome of injection site pain and injection site swelling was reported as not recovered.   The causality between the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Muscle soreness around the rib cage travelling upwards along the back then settling into limbs within the next 24hrs. Swollen elbow and swollen wrists, both arms, severe forearm muscle pain left arm, aching elbow and wrist joints.
Right Red swollen hot to touch- entire thigh, Zyrtec, Hot pack, Augmentin ES 600
Information has been received from a nurse practitioner concerning a 20 year old female who on 01-JUL-2008 was vaccinated with the first dose of GARDASIL (lot no. 0250X) (route not reported). Concomitant therapy included birth control pills (unspecified), lithium (unspecified), SYNTHROID and CECLOR. On 03-JUL-2008, two days after vaccination the patient experienced eye twitching. The patient was testing for Lyme disease, thyroid dysfunction, vitamin B12 deficiency and the patient had a magnetic resonance imaging (MRI) done to rule out an aneurysm. No diagnosis was given. The patient sought medical attention by calling the physician. Additional information has been requested.  11/06/2008  Records received from OBGYN. Exam 7/1/08 with normal PE. Pt will not be getting 2nd HPV vax due to developing an eye twitch 2 days s/p 1st vax on 7/1/08. Has seen PMD, Neuro and endocrine with no dx.  12/19/2008 MR received from PCP beginning 7/18/-12/2/2008. Initially seen 7/18/08 with c/o of feeling unwell and intermittent eye twitch, lid lag and torso twitches. Seen in ER and dx: sinusitis-tx-abx. PE (+) for ptosis and R eye lateral and upward deviation, RUE and R upper eyelid weakness. Concern for MS or MG.  DX: Palsy, parial 3rd nerve.  Muscle fasculations. Referred to neuro who felt either sinusitis or psychiatric etiology.  Returned 8/11/08 with c/o throbbing head pain/pressure on R side of head. Assessment:  Muscle fasiculations.  H/A etiology unclear. Ophth exam (=) for ptosis but no ocular componant to h/a. Seen in referral  for 1 mon hx of eye twitching and muscular fatigue on exertion.   ROS (+) for 18# wt loss, eye twitching, hip soreness, acne, hair loss and abnormal bruising.  PE (+) for R eye lag. DX: Hypothyroidism.  Muscle fasciculations. OV 9/19/08 in f/u. Dx: Infection, viral. Rx: Doxycycline. Flu vax 12/2/08. F/u for ER visit for SOB/sore throat. DX: Strep throat.
increasing body wide weakness 1 day after vaccine, found to be in fulminant renal and hepatic failure with +troponin and rhabdomyolysis with no other preceding symptoms or significant history
This spontaneous report as received from a nurse concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On unspecified dates on or after 01/03/2018, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot N000291, exp 02/23/2019; lot M037248, exp 02/21/2019; lot N009802 exp 12/19/2019) for prophylaxis, which had a temperature excursion of 32F up to 35F for 12 Minutes. It was reported that the vaccines did not have previous temperature excursion and It was detected because of a data logger. No adverse events were reported.
Approximately 10 minutes after receiving FLUAD, the patient stated she felt intense pain in her groin region and had difficulty walking. She was asked to sit down and stay sitting down to be monitored. She refused the offer to call an ambulance. After approximately 20 minutes, the patient stood up and walked a few feet with a cane. She then proceeded to walk to a bathroom several feet away. Upon returning, the patient stated that she was feeling better but had never felt as bad or as sharp of a pain ever before. She has no previous reactions to the same vaccination.
Site soreness 30 day after receiving flu shot - lump under skin - soreness lasted 2 days then left.
patient has had a bump and area has been red and that it hurts on and off since getting the shot. Patient was seen by a dermatologist and he told her to report it to us.
Patient asked to lay down because she usually gets dizzy after receiving vaccines. Patient closed eyes and briefly became unresponsive to conversation, but awoke again with a sternal rub. Patient was monitored for 30 minutes and left at baseline.
couldn't see/focus & finally collapsed as I reached a cot/faded; couldn't see/focus & finally collapsed as I reached a cot; strange taste in my mouth; strong pre-syncope symptoms/faded in and out 5 times in an hour; Felt very hot; sweating profusely; weakness in arms; couldn't see/focus & finally collapsed as I reached a cot; blood pressure & heart were high; blood pressure & heart were high; shook in recovery for 5 hours; Dizziness; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at 46-years-old) as a single dose for COVID-19 immunisation. Medical history included Dysautonomia postural orthostatic tachycardia syndrome (POTS), Mast Cell Activation Syndrome, Ehlers Danlos Hypermobility Type, past thyroid cancer, past cerebral venous sinus thrombosis (CVST), migraines, vertigo, dystonia, Meibomian Gland Dysfunction, pituitary gland enlargement, gluten allergy, and dairy allergy, all from unknown dates and unknown if ongoing. Concomitant medications were unspecified, reported as too many to list. The patient previously received diphenhydramine hydrochloride (BENADRYL), fentanyl, and nitrous oxide, all from unknown date for unknown indications and experienced allergy. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in four weeks. The patient reported she was fine for 25 minutes and at 15:30 she began to experience strange taste in her mouth. Then she had strong pre-syncope symptoms. She felt very hot, was sweating profusely, had weakness in arms, couldn't see/focus and finally collapsed as she reached a cot. Her blood pressure and heart were high, which was not normal for her in presyncope. She reported she faded in and out 5 times in an hour, which was also not normal. She shook in recovery for 5 hours, which was also not normal for her. She reported dizziness & presyncope had persisted for 5 days so far. The patient reported medics on site took vitals and gave cool cloths. The clinical outcome of dizziness and presyncope were considered not recovered; the outcomes of the other events were reported as recovered with lasting effects. Since vaccination the patient had not been tested for COVID.
Fatigue; Feel ill; This case was reported by a physician via sales rep and described the occurrence of fatigue in an unspecified number of child patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose and Bexsero at an unknown dose. On an unknown date, unknown after receiving Menveo and Bexsero, the patient experienced fatigue and feeling unwell. On an unknown date, the outcome of the fatigue and feeling unwell were unknown.   It was unknown if the reporter considered the fatigue and feeling unwell to be related to Menveo and Bexsero.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician stated that it has come to her attention that the patients seem to have more fatigue or feel ill when both Menveo and Bexsero are given at the same time. The reporter did not agree to follow up from GlaxoSmithKline
Initial information received on 05-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult (unknown demographic patient) patient who administered an expired vaccine MENACTRA. 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 (D CONJ) VACCINE lot number not reported. It was an actual medication error due to expired vaccine used. It was not reported 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.