chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report was received from a female pharmacist of unknown age who refers to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were not known and could not be calculated. The pregnancy outcome was pending. On unknown date, during the administration of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) to an unspecified patient, a few drops of the reconstituted vaccine came out of the needle and went on her own skin. No adverse symptom was reported. Additional information is not expected because there was no consent to contact the reporter.; Sender's Comments: US-009507513-1703USA008814:
Myalgia, Fever, Diarrhea, NauseaVomiting, chills, excesively tired Narrative:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient waited 15 minutes then checked out. She then walked to the water fountain/restroom area where she fainted. Patient woke up shortly afterwards and we had her remain laying down and elevated her legs. When she felt better we had her sit on the floor for a bit, then moved her to a chair when she felt comfortable. Patient drank 3 small bottles of water and felt better. Patient's husband came to the pharmacy to assist patient in getting home.
fever; sneezing runny nose; sneezing runny nose; headache; diarrhea; vomit; fatigue body ache; fatigue body ache; rash on stomach (upper leg, calf, private area); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHINORRHOEA (sneezing runny nose), SNEEZING (sneezing runny nose), DIARRHOEA (diarrhea), PYREXIA (fever) and RASH (rash on stomach (upper leg, calf, private area)) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack in 2000 and Knee surgery NOS. Concurrent medical conditions included Hypertension, Obesity and Arthritis. Concomitant products included MELOXICAM (MOBIC) and ACETAMINOPHEN for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced RASH (rash on stomach (upper leg, calf, private area)). On 01-Feb-2021, the patient experienced FATIGUE (fatigue body ache) and MYALGIA (fatigue body ache). On 05-Feb-2021, the patient experienced VOMITING (vomit). On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 07-Feb-2021, the patient experienced HEADACHE (headache). On 08-Feb-2021, the patient experienced RHINORRHOEA (sneezing runny nose) and SNEEZING (sneezing runny nose). On 10-Feb-2021, the patient experienced PYREXIA (fever). On 31-Jan-2021, RASH (rash on stomach (upper leg, calf, private area)) had resolved. On 07-Feb-2021, DIARRHOEA (diarrhea) had resolved. On 09-Feb-2021, RHINORRHOEA (sneezing runny nose) and SNEEZING (sneezing runny nose) had resolved. At the time of the report, PYREXIA (fever), FATIGUE (fatigue body ache), MYALGIA (fatigue body ache), VOMITING (vomit) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consulted Jan 27 and 28 Jan: Medicine prescribed by physician follow adverse events include Zyrtec daily four days and Benadryl daily four days.
The pt experienced abdominal pain, nausea, vomiting, and diarrhea. Treated with pepto bismol. 60 day follow-up states the pt also experienced pradnial pain, diagnosed with gastroparesis, neuropsychological problems, auditorial deficits, memory loss, concentration loss, nausea, loss of fine motor skills, loss of complex visual memory, back pain,  headaches, candida esophagus, ammenorrhea, decreased immune system, and multiple illeus's.
5 month old baby was administered kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B vaccine (received Hepatitis B vaccine on 23rd November 2021). Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (DTAP VACCINE), POLIOMYELITIS VACCINE INACTIVATED (IPV (INACTIVATED POLIO VACCINE)), HIB VACCINE and VAXELIS.   On 26th April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 26th April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-May-2022 Reporter's Comments: Nurse reported a 5 month old baby was administered kinrix. Vaccine history (DTAP,Inactivated Polio vaccine, Hepatitis vaccine, HIB- Merck- Snaofi- Vaxelis) in February 2022 and on 23rd November 2021: Hepatitis B vaccine. The Healthcare professional said that she would call back with patient information and other details as she did not have permission to give it out. The reporter consented to follow up. Additional Supportive Information: The 5 month old patient was administered with Kinrix, which led to inappropriate age at vaccine administration.
Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported  No Treatment information was reported.
07/03/22 presents to Emergency room for "fall". PMHx of "osteoporosis" " covid in 04/2022"
This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot# M032649 with expiration date on 11-NOV-2018; and lot # L048848 with expiration date on 09-AUG-2018) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hives on 10/01/2003 at 18:45.  Benadryl.
1st few days expected to be sick. Then the ?pause? so expected to be nervous, but 2 weeks out started the dizziness, panic attack, heart arrhythmia headache, brain fog, muscle soreness and overall unwell feeling.  I have lost time at work. The money this is going to cost me out of pocket for ER visits. Wasting peoples time.  I meditate have good people in my life, I?ve never had this typ of panic and feeling and legit arrhythmia. On beta blocker. Told to schedule a cardiologist visit.  Prob gonna need some anti anxiety meds.  There is no help out there for this. Thought doing the right thing to get vaccine.  I?m not antivax but this is super upsetting.  I?m an otherwise normal healthy social person. I cannot even go to friend house b/c of dizziness racing heart and panic
Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
38 YO  was administered Engerix-B 0.5ml; 38 YO  was administered Engerix-B pediatric; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 38-year-old female patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: No reactions were reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received a pediatric dose of Engerix B, which led to underdose and adult use of a child product.
patient states that she has soreness from injection site to neck area and axillary areas. states that her shoulder is stiff as a rock. instructed patient to take some acetaminophen and to ice the area. told patient that per manufacture localized reactions resolve within 3-5 days.
After 2nd injection, no cooing, has not bubbled since vaccination. CT of head negative. Hearing screen-pending;
Chest Pain, Heavy/Strong heartbeat, Indigestion/Heartburn Feeling, Constipation, Headache. All still ongoing.
The patient's mother lied and said the patient was 12 years old.  After the vaccince was given and processed through facility, the facility sent back a message saying that the patient wasn't 12 years old even though the mother attested that her daughter was 12.
Shaking chills; Significant headache 8/10 pain; temp of 101.5; Nausea; Emesis; Energy not quite back; This is a spontaneous report from a contactable Other-HCP (patient).  This 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246), via an unknown route, on 07Jan2021 (at 15:15) at single dose at left arm for COVID-19 immunisation, administered at hospital. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EH9899) on 18Dec2020. No other vaccine was received in four weeks. Relevant medical history included mild seasonal allergies. Patient allergies included erythromycin-hives. Relevant concomitant medications included colecalciferol (VITAMIN D), and cetirizine hydrochloride (ALLERTEC) as antihistamine therapy. Pre-vaccination and post-vaccination COVID tests were not performed. On 08Jan2021, after 12 hours of receiving the 2nd dose, the patient had shaking chills followed by significant headache 8/10 pain, temp of 101.5 and significant nausea with emesis, very difficult to take  paracetamol (TYLENOL) or get in fluids. She was absolutely fitful for 30 hours. In bed wondering if it would stop, then after fever broke rest of symptoms slowly let up. Day three low grade temp of 98.9, energy not quite back but feeling better. The patient was not treated for the events. She was recovering from the events.
I26.99 - Other pulmonary embolism without acute cor pulmonale N17.9 - Acute kidney failure, unspecified
This spontaneous report as received from a pharmacist refers to a female patient who was younger than 50 years old. "About a year ago", in approximately May 2012 the patient was vaccinated subcutaneously with ZOSTAVAX (0.65 ml, lot # not reported). It was reported that the patient developed a rash in approximately May 2012. The patient stated that the rash at the injection site was transient and resolved on its own. There was no treatment given for the event. No lab diagnostics studies were performed. The pharmacist did state that the patient did not see a physician concerning rash. The patient sought medical attention to pharmacy. VZV packet declined. Additional information is not available.
Shot #1 - severe headache, chills, nausea vomiting, muscle aches pains all over lasted 24 hours I had a headache everyday up until lady week, I now get a headache 3-4 times a week. I also have extreme fatigue, I go to bed 6-7 pm every day.  I have had a rapid heartbeat 90-115 & higher with any exertion e.g. climbing stairs, walking ..  Shot #2 - massive headache... fatigued
Swelling of entire right thigh, began within 2 hours of immunization, generalized papular rash. Local swelling left thigh.
Numbness and tingling to mainly L face as well as L arm and foot. Feeling as if I am going to pass out at any time. Have not passed out, just very "Fuzzy". Started approximately 15 minutes after injection and slightly worsened for the next two hours. After one night sleep, L face and L hand remain mildly numb and tingly as well as the foggy feeling mentally.
Patient admitted to the hospital 3/16/21 2 weeks post #2 Moderna COVID-19 vaccination with sepsis, atypical pulmonary infiltrates, and hypoxia. Patient treated for pneumonia and discharged home 3/19. Patient readmitted to hospital 3/31/21 with dyspnea, CT with worsening miliary appearing pattern.
Fevers and rash 1 w after vaccines, now red bumps everywhere. Mom thinking MMR vax reaction. no current fever, just irritable. Mom does not know how high fever was, low grade per mom and some vomiting 2x in one day, none since.
16 weeks pregnant, received the Janssen vaccine and had typical symptoms (chills fever aches ) but also had  vomiting and had intense sharp pain from lower right side of abdomen that shot up to my lung area that caused me to double over and cry (this lasted for 1-2 minutes prior to vomiting. I feel better today minus a headache  and did not require an in person visit but my ob recommended that I report since vomiting isn?t as common of a symptom and there isn?t much  data on pregnant women
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: ER8732), in left arm, on 23Apr2021 as dose 2, single (Lot number: EW0164), in left arm and on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Major depression" (unspecified if ongoing); "generalized anxiety" (unspecified if ongoing), notes: generalized anxiety. There were no concomitant medications. Past drug history included: Compazine, reaction(s): "known allergies Compazine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache for over a week and hasn?t gone away. Sore throat getting worse.
Mildly tachycardic 5 minutes post injection. Patient reported feeling anxious & warm. No rash, swelling or redness in face. Pulse rate every 10 minutes post injection 90, 88, 76. Released patient after 30 minutes, recommended BENADRYL & to contact PCP if symptoms worsened or continued. Called patient 1 hr after event & she said her symptoms resolved.
DIZZINESS; SHORTNESS OF BREATH; PULMONARY EMBOLISM; This spontaneous report received from a physician concerned a 48 year old male. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. The batch number was not reported and has been requested.  No concomitant medications were reported. On APR-2021, the patient experienced pulmonary embolism.  Laboratory data included: Computerized tomogram thorax (NR: not provided) positive, Ear, nose and throat examination (NR: not provided) negative and Platelet count (NR: not provided) 197.  On 04-APR-2021, the patient experienced dizziness and shortness of breath. Full neuro, cardiac, Ear, nose and throat workup and evaluation was negative in Erectile dysfunction and follow up clinics. Patient had a Wells Criteria of zero, and was hemodynamically stable, platelet was 197. Patient started with DDIMER which was 560 and later chest Computerized tomogram thorax was positive for right lower lobe Pulmonary embolus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, shortness of breath and pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s-Pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Nausea post vaccination History of vaso/vagal response after a shot was given (blood was drawn)  Patient was given crackers, juice, water Improved symptom of nausea Patient was sent home
Patient had a reaction to Moderna Booster within a month of vaccination.  Her tongue would pucker and rash a bit when she would try to taste something and she could not taste her food.
Lost consciousness, convulsed 20-30 seconds, layed down with wet paper towel on head started to leave and lost consciousness again while walking. Very grey in color. No color to lips. Sat down in chair. Convulsed. Lay down with towel, Coke < 5 minutes.
Immediate large, red itchy bump formed.  White center with red the size of arm where injection was given. This followed by headache and stomach ache. The next morning very tired and sore muscle type pain in body.  Arm still itchy night of day 2.
Patient had severe pain after getting the vaccine, so he reached out to his doctor, he had to do a MRI on his shoulder and he was diagnosed with shoulder injury related to vaccine administration (SIRVA). He is currently getting physical therapy
I was injected with the Pneumonia and Shingrex vaccine on 4-22-19. By 4/23/19 I began to experience headache, body aches, fatigue, soreness at the injection site. By 4-27, 2019 I wasened with a deep dry cough, fever, extreme fatigue and body aches. I had begun then to stop eating. On 4-29-19 I visited the ER and was diagnosed with pneumonia and hybotremia. After the first round of antibiotics, my pneumonia had worsened. I began a second round of Levitrin, and confined myself to bed rest and trying to eat/drink. This is the sickest I have been in my 67 years! I continue to believe I had an adverse severe reaction to the vaccine, as was completely healthy (exception of ulcer) before. Thank you!
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX in an unknown arm. An unknown amount of time after vaccination with KINRIX, the subject experienced swelling of the arm at the injection site where the vaccine was administered. At the time of reporting the outcome of the events was unspecified.
Moderna COVID?19 Vaccine EUA:  persistent, high-pitched ringing in both ears, noticeable at all times of day and night.
On May 3rd I received my first jab.  Days 2 and 3 my arm was pretty sore. Like a Charlie horse combined with a sore arm workout.  Day 4 that soreness went away but I felt fatigued. It was like I was trying to move around under water. That lasted only one day.  Day 5 my lymph node under my arm started to get sore. That lasted 3 days.  Day 8 - Last night my outer arm started to feel funny. I looked down and had this good sized welt raised up. It was about 5? by 1?.  On May 24th I received my second jab.  About 4 hours after my jab  my face became flush. The tips of my ears got hot. I went to bed and woke up with a fever between 100.4 to 100.9 in the morning.  My body ached, my eyeballs hurt to move side to side.  In the afternoon I had swelling in my scrotum sack and testicles ached. My fever topped out at 101.2 in the evening. The next day my fever went away and the swelling in my scrotum was gone.  My testicles still occasionally ache during the day.
Bad headache in morning. Very unusual for me. In my eyes. Hard to concentrate on work at computer. After an hour took a short nap and completely went away. Several days before had sharp pain in my calf but thought it could be a muscle cramp. That was also very unusual.
Vaccinator reported that the needle barely punctured the skin causing some vaccine to be lost down the arm and the remainder of vaccine 0.2 ml left in the syringe. Per CBC guidelines, since less than half a dose was administered, the vaccination was repeated.
Patient fainted (was pale, clammy, not responsive with thready pulse), was not able to see for 5 min after recovery, was hypotensive. Legs elevated, smelling salt, glucose tablet and water. 4:55 pm to 5:30. Symptoms resolved (S/P felt norm).