chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose a few years ago, 2nd dose about 3 months ago; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix a few years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The pharmacist stated that the patient did not come back for the second dose until about 3 months ago from reporting date. The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule. The patient came back on the day of reporting expecting a third dose, but a third dose was not administered. The reporter was trying to determine if a 3rd dose needed to be administered so she called for recommendations. After the information was provided to the healthcare professional, she stated that she would not be administering a 3rd dose. The registered pharmacist (RPh) was in a rush to receive information stating that she had a long line, thus did not probe any further for additional information. She also declined to have contact information stored and follow up. The reporter did not consent to follow up.
Symptoms started in left ear with itchiness around March 24 and by March 26 the itchiness had spread to his  arms, legs,  hands, and neck with a fine red rash and some areas with red lesions. Warm water made it worse. Worst areas on knuckles and near his elbows along with the back of his neck. Took Benadryl with no resolution.  He saw his doctor on Monday, and received a steroid shot and prescriptions for prednisone and hydroxyzine. By April 2, he was almost done with his Medrol dose pack and felt much better. He felt pretty normal by his call to the health dept. On April 7.
Patient developed edema at injection site at 24 hrs post-injection and lymphedema in (L) hand 48 hours after injection. RPh saw patient had Hx breast CA but gave inject SQ in LA anyway because patient wanted to cook holiday dinner with (R) arm. RPh should have insisted on (R) arm since (L) mastectomy.
This spontaneous report was received from a pharmacist concerning a female patient with unspecified age, gender, pertinent medical history or drug reaction/allergies. On October 2011, the patient was vaccinated subcutaneously with first dose of PNEUMOVAX 23 (dose was not reported). Recently, in approximately 2012, the patient received the second subcutaneously dose of PNEUMOVAX 23 (dose was not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, after received the second dose, the patient's arm was very red and swollen and she experienced loss of function (disability) for which she reported went to the emergency room (ER) of hospital. An unspecified treatment was given for the event. The patient's outcome was unknown. Additional information has been requested.
Myalgia, Arthralgia, Fever, NauseaVomiting, Soreness at injection site Narrative:
PATIENT RECEIVED FLU SHOT, A FEW MINS LATER FAINTED. WAS RESPONSIVE AFTER A FEW SECONDS AND NORMAL BREATHING. CALLED 911. EMS CAME, CHECKED VITALS. PATIENT WAS GOOD AND ABLE TO LEAVE WITHOUT AMBULANCE.
10/3 body/muscle aches, sore arm at shot sight, 10/4 fever began and stayed between 101 and 103 for two days. 10/5 diarrhea began, lasting two days - very tired/weak/slept most of day/night for two days.  Today 10/6, no fever, no aches, slight diarrhea, very tired.
THROAT SENSATION LIKE TICKLE; COUGH; SHORTNESS OF BREATH; LIGHT PRESSURE ON CHEST; FELT LIKE HAVING AN ALLERGY; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's past medical history included anxiety, and endometriosis, and concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced watery eyes when treated with ibuprofen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site pain. On 10-APR-2021, the subject experienced throat sensation like tickle. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced light pressure on chest. On 10-APR-2021, the subject experienced felt like having an allergy. On 12-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Laparoscopy (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt like having an allergy, throat sensation like tickle, and injection site pain, and had not recovered from cough, shortness of breath, and light pressure on chest. This report was non-serious.
pt arm became red & hot around the site approx 15 mins p/shot given; pt started to feel hot & flushed; c/o SOB & pointed to throat; taken to ER;
itchy; hives; redness; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), URTICARIA (hives), ERYTHEMA (redness) and RASH (rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy), URTICARIA (hives), ERYTHEMA (redness) and RASH (rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy), URTICARIA (hives), ERYTHEMA (redness) and RASH (rash) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Treatment details included Tylenol, antihistamine.
She was sitting in a chair in our post vaccination area required after vaccination is administered and passed out and fell to the floor.  We immediately called 911 and I checked for breathing and pulse and she had both. She was non responsive for a minute or two but eventually became aware of what happened. I waited with her until paramedics arrived. Paramedics/EMT's arrived at the scene within 10 minutes and rendered aid. She was taken to the Medical center.
I have an eczema like rash that appears, and goes away. Mostly in late evening, but at other times as well. These are mostly small (lots of them) bumps on arms, torso, behind, sometimes legs or feet. It seems like it could be drive by outdoor plants (weeding yard). I have never had such a reaction when weeding. (I am not even allergic to poison ivy).  - - Problems not bad enough to go to Doctor at this time (although if it continues, I will). It is just different than what I am used to, and annoying.
My daughter is having ticks/twitches.  Her head keeps having small jerks.  She?s never had this before.
Information has been received from a pharmacist concerning a 12 month old female with no allergies or medical history who on approximately 26-MAY-2006 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. In May or June 2006, the patient developed a fever. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested
Patient described chest "tightness" and felt she was getting warm about 15 minutes after the vaccine.  She was given water, and felt that she was "feeling less warm" after about 5 minutes (20 minutes after vaccine), but was still experiencing chest tightness.  The clinic staff was informed, and they took over care of the patient.  They did an EKG which was normal, and thought the chest pain was not cardiac related.
I've had worse flue's bugs; Initial information received on 28-Nov-2021 regarding an unsolicited valid social media non-serious case received from a consumer or non-healthcare professional via social media via Agency.  This case involves a patient (unknown demographic) who had worse flue's bugs (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious had worse flue's bugs (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got my shoot & fighting the flue now , I've had worse flue's bugs."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Was offered the Twinrix shot ( Hep.A and Hep. B) during an HIV clinic.  The client spoke some english and needed an interpreter(which was in the room).  After the HIV counseling was almost done, he was asked if he wanted a Hep. A or Hep. B shot.  After he was counseled for it, he stated he wanted the combination shot.  Twinrix was given.  After client left, it was discovered client had recieved a Hep. B shot in STD clinic, prior to HIV counseling.
I had numbness and tingling and tremors in my body subsequent weeks following receiving my vaccine. I had neurological problems so I contacted my doctor and informed her about my condition, and she did nothing in regards to prescribing me any medication or therapy to help with my problem. She sent me to a specialist, and he didn't address any of my numbness or anything. I haven't gone to anymore doctors since then because the doctors I went to wrote me off.
It started 4-5 hours after my shot. I woke in the middle of the night with aches, fever, nausea, headaches, and fatigue. The worst of it lasted about 24 hours, but the headache lasted about a week.
Information has been received from a physician concerning an adult male who on 09/21/03 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast).  The physician reported that in approximately October 2003, the pt's urine drug screen was positive for cocaine.  It was noted that the pt felt his vaccination with hepatitis B virus vaccine rHBsAg (yeast) may have caused the positive cocaine result.  Unspecified medical attention was sought, but no treatment was required.  Additional information has been requested.
Low grade fever turning into sore throat lasted until 11/11/2012. Chest congestion, cough, nasal drainage 11/12/2012 through current.
Extreme muscle soreness in shoulder of arm injected. Shoulder joint pain also present. Restricted movement of arm at the shoulder joint due to pain. Has persisted for 4 weeks now.
I have a deep pain in left arm and great weakness in left arm. June 10, 07 fever and chills all night.
(Report per patients wife ) Patient took his usual nap around 12pm. She found him lying in the bed unresponsvie at 2pm. EMS was not called. Patient's wife called the Funeral home.
PE; This is a spontaneous report from a contactable other health care professional (HCP). A 39-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included deep vein thrombosis (DVT), pulmonary embolism (PE). Patient had not covid prior vaccination. It was reported that patient received concomitant medications within two weeks of vaccination, no details reported. It was unknown if patient received any other vaccines within four weeks prior to the COVID-19 vaccine. On 28Sep2021 patient experienced pulmonary embolism (PE). Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. It was unknown if patient was treated for the event. It was unknown if patient was covid tested post vaccination. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
pain from injection site towards up to the neck; bad irritation; Ear was aching; Felt like crook in the neck; pain from injection site towards up to the neck,When she would touch the injection site and it was still sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN (pain from injection site towards up to the neck), HYPERSENSITIVITY (bad irritation), EAR PAIN (Ear was aching), MUSCULOSKELETAL STIFFNESS (Felt like crook in the neck) and INJECTION SITE PAIN (pain from injection site towards up to the neck,When she would touch the injection site and it was still sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00TM20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced NECK PAIN (pain from injection site towards up to the neck), HYPERSENSITIVITY (bad irritation), EAR PAIN (Ear was aching), MUSCULOSKELETAL STIFFNESS (Felt like crook in the neck) and INJECTION SITE PAIN (pain from injection site towards up to the neck,When she would touch the injection site and it was still sore). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, NECK PAIN (pain from injection site towards up to the neck), HYPERSENSITIVITY (bad irritation), EAR PAIN (Ear was aching), MUSCULOSKELETAL STIFFNESS (Felt like crook in the neck) and INJECTION SITE PAIN (pain from injection site towards up to the neck,When she would touch the injection site and it was still sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported that, patient had a bad irritation and had to put a heat pad on it. The patient was concerned that the pain lasted a few weeks. The patient visited the doctor and the doctor did not find anything.
Tingling lips; they did not swell, just felt tingly. Went away after a couple hours.
no adverse event; The patient received one improperly stored dose of VARIVAX; This spontaneous report was received from a nurse prescriber concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On 11-MAR-2020, the patient received one improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot # S028920 and expiration date 16-SEP-2021 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with properly stored sterile diluent (lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion of 6°F to 14°F (5.69F) degrees Fahrenheit for 1 second, as recorded by a data logger. There was a previous temperature excursion of 6°F to 14°F (5.81F) for 28 minutes. No additional adverse effect reported.
on 20APR93 pt woke up having no appetite & chills; these sx lasted 3 days; On 20APR93 pt lt arm also began to hurt severely, became swollen from shoulder to elbow, was difficult to move;
Pt came in 2 days after ZOSTAVAX injection and his entire upper right arm area was swollen (around injection sight) from elbow to under arms no pain, just very red & swollen - he gave him BENADRYL.
nausea, shortness of breath light headedness loss of vision loss of hearing tingly fingers to right hand.
J96.00 ACUTE RESPIRATORY FAILURE 12/21/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Elevated BP" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Patient did not have any known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: Elevated; SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300000098 Same patient, different product and event;
GSK has profiled vaccine syringes.  They may have been around for awhile, but we just started using them.  The syringes feature a uniquely colored band around the plunger to differentiate between vaccines which is nice.  The thing I particularly dislike is how small the print is on the syringes.  It has to be 5 print!!!  I can't imagine how nurses feel when I myself have problems reading them upon dispensing.  The syringe on the left is a pediatric flu vaccine (FLUARIX) and the syringe on the right a DTaP (INFANRIX).  I know for vaccines the lot and exp typically needs to be recorded when administering.  So practitioners administering these are going to be interpreting the smaller print unless they happen to notice the print on the other side of the syringe.  Error did not reach the patient.
After 1st dose had Shingles 8 times; 1st dose 4 years ago, no 2nd dose yet; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included giant cell arteritis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK receipt date :04-NOV-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient had giant cell arteries before beigning treatment with actemra to received first dose of shingrix vaccine and experienced shingles,before had the second dose of shingrix. His/her rheumatologist suggested to wait. That was 4 years ago. The patient had light case of shingles 8 times since. The patient had been clear for almost year.   The doctor suggested patient to get shingrix again. The patient asked whether he/she should received the second dose only or series over again. Additional Supportive information:Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Both times patient got horribly ill; Initial information regarding an unsolicited valid non-serious case received on 14-Dec-2020 from a consumer (patient) via social media.  This case involved a patient for whom it was reported that both times patient got horribly ill(Illness), while patient received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient ingot the shot twice, both times patient got horribly ill (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was reported as Unknown for reported event.  There will be no information available on batch number for this case.
Body aches, fatigue, blisters inside mouth, swollen glands, sores on lips and gums, swollen lips.
Severe itching behind right and left knee and left arm. Swelling of the left ankle and left arm. Skin erythema left arm and left and right calves Time for 7 days
Patient developed severe HA, nausea, profuse vomiting less than 36 hours after being vaccinated.