chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The following information was obtained from the above-referenced literature article received on 11 September 2008. The article included background information on vaccine hypersensitivity and a detailed algorithm that provided a rational and organized approach for the evaluation and treatment of patients with suspected hypersensitivity. Also included were cases of suspected allergic reactions to vaccines to demonstrate the practical application of the algorithm. Information in this case pertains to a patient who experienced an allergic reaction, described as follows: "A 1-year-old child received hepatitis A (dose 1), pneumococcal conjugate (dose 4), and HiB (dose 4) vaccines. The next day, she developed low-grade fever (38.2 degrees Celsius) and diffuse hives except on the palms and soles. She was taken to an urgent care clinic, where she was given acetaminophen and diphenhydramine. The fever resolved, but the hives persisted for 4-5 days. She did not have any other symptoms. She was previously healthy with no relevant medical history, allergies, or atopic disease. The impression was that this most likely represented a serum sickness-like reaction, although an IgE-mediated, immediate-type reaction could not be ruled out. Also, an intercurrent infection could have caused the symptoms, which persisted for 5 days, and the vaccine may have played no role in the pathogenesis." The article did not report vaccine trade names, manufacturers, lot numbers, route/site of administration and date of administration. Application of the algorithm to this case was then described: "We recommended checking hepatitis A titers and referral to an allergist for skin testing before her next hepatitis A dose, beginning with a prick test to the full-strength vaccine followed by intradermal tests at 1:100 and 1:10 dilutions. Skin testing could have been performed to the pneumococcal conjugate and Hib vaccines, but this was considered optional because no additional doses of those vaccines would be needed. Negative skin tests suggest that the patient is unlikely to have an immediate-type reaction with future doses; however, skin tests have not been shown to have predictive value for serum sickness-like of other types of non-IgE mediated hypersensitivity reactions. As per the algorithm, if the skin test is positive, if she had hepatitis A antibody concentrations that are presumed to be protective, then we would withhold subsequent doses. If skin testing is positive but antibody concentrations are low and there is a significant concern about the risk of hepatitis A exposure, then a graded rechallenge with hepatitis A vaccine in a controlled environment that has the personnel and equipment to manage appropriately anaphylaxis or another serious adverse reaction would be recommended. This case is reported in the same literature article as case 2008-02851.
muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain. On an unknown date, the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter wanted to know how long he/she should expect the muscle aches, after receiving Shingrix, to last. Additional Supportive Information: The follow up would not possible as no contact details were available.
Date and time of vaccination: (list both if they received both shots):  02/18/21 no time indicated, face broke out with a rash (doctor gave her prednisone shot) 03/09/21 5 days later face broke out with a rash, a light circle rash around the injection site  stated she felt weak  Brand and lot of vaccine:   Pfizer  Lot 1# EN6198 Lot 2# TN6206 Doctor gave her prednisone to alleviate her symptoms
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Cold (Really bad). Concurrent medical conditions included Allergy to NSAIDs (Aspirin), Multiple sclerosis, Allergy to animals, Penicillin allergy, Juvenile diabetes, Type 2 diabetes mellitus and Anxiety. Concomitant products included METFORMIN, DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE (NUEDEXTA [DEXTROMETHORPHAN HYDROBROMIDE;QUINIDINE SULFATE]), FAMPRIDINE (AMPYRA), EMPAGLIFLOZIN (JARDIANCE), GABAPENTIN, SEMAGLUTIDE (OZEMPIC), CEFIXIME (FLEXERIL [CEFIXIME]), ROSUVASTATIN, VITAMIN C [ASCORBIC ACID], LORATADINE, DICLOFENAC (VOLTAREN [DICLOFENAC]), ACETAMINOPHEN and OCRELIZUMAB (OCREVUS) for an unknown indication.  On 16-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  It was reported that patient had a fever and other stuff after the vaccinations. No treatment medications were reported.
pt recv vax;pt would not stay awake per mom;mom stated p/ vax,given apap;next am, to pc to ped, was told to call hlth dept; pt has no problem at this time;
Pt recvd vax & 12NOV92 6PM devel joint, muscle & stomach pain along w/nausea h/a; sx lasted for 2 days;
Low grade fever, body aches and a headche  1st , 05/17/2021, 6.15 oz
Patient developed symptoms of bilateral posterior chest wall pain 2 weeks after the second dose, resolved after 2-3 days, also cough, runny nose 4 weeks after vaccination( chest CT scan showed multiple nodules)then had left leg cramps, 5 weeks later developed  severe left and then posterior pleuritic pain  had CT A PE study with small bilateral pulmonary emboli.
HIgh fever 101-102.  Severe leg aches. Fatigue.  Chills. Thirst.  Overall malaise.
Severe hypoglycemia episode. It started about 4 hours after the vaccine. I did two rounds of basquimi glucagon at home, one round in ambulance and two rounds of Dextrose 50 in hospital er.
patient received the Pfizer vaccine already,received moderna vaccine; non-Moderna COVID19 Vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (non-Moderna COVID19 Vaccine administered) and OVERDOSE (patient received the Pfizer vaccine already,received moderna vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced WRONG PRODUCT ADMINISTERED (non-Moderna COVID19 Vaccine administered). On an unknown date, the patient experienced OVERDOSE (patient received the Pfizer vaccine already,received moderna vaccine). On 27-Jan-2021, WRONG PRODUCT ADMINISTERED (non-Moderna COVID19 Vaccine administered) had resolved. At the time of the report, OVERDOSE (patient received the Pfizer vaccine already,received moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This is a spontaneous report from a contactable nurse (from physician's office) via a Pfizer sale representative. This nurse reported events for three patients. This is one of the three reports. An elderly (over 65 years of age), male patient of an unspecified ethnicity started to received PREVNAR 13 (lot J67647), via an unspecified route of administration, on an unspecified date, as a single dose. Medical history and concomitant medications were not reported. The patient experienced severe itching and little bumps at the injection site on an unspecified date; per the reporting nurse there was no redness and no swelling. The clinical outcome of severe itching and little bumps at the injection site was unknown.
Patient purports experiencing overwhelming muscle weakness so much so she could not sit up in bed. She slid off the side of her bed yet could not move and lay on the floor for 2.5 hours before she could maneuver to her bathroom. She experienced severe muscle weakness and dizziness and blurred vision for several days and says she did not feel normalcy until 8/25/18.
Abdominal pain began on 3/31/21 and lasted 5 days. Went into urgent care on 4/4/21. was referred to ER, diagnosed with appendicitis and emergency surgery was performed 4/4/21.
her eyes feel "like there is sand in them"; the medication spraying in caller's eye s; the medication spraying in caller's eye s; This spontaneous report was received from a medical assistant regarding to herself; a 25-year-old female patient. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patient had drawn  hemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB)  into a syringe and needle of syringe malfunctioned and retracted resulting in the medication spraying in caller's eyes.  Caller states she did rinse eyes out with water but states her eyes feel "like there is sand in them" (foreign body sensation in eyes). Strength, dose, frequency, route of administration, lot number and expiration date of the suspect vaccine were not reported.  The outcome of foreign body sensation in eyes was unknown.     The causality assessment between the event and the suspect vaccine was not provided.
Initial information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medication, drug reactions or allergies were not reported. On 07-AUG-2015 the patient was vaccinated with an expired dose of GARDASIL 9, intramuscular, lot number reported as J011960, expiration date 06-AUG-2015, (anatomical location, dose and dose number were not reported). No adverse effects were reported. Lot number J011960 is an invalid lot number for GARDASIL 9. Additional information has been requested.
Received vaccines on 09/01/2005 at 1pm, next am welp noticed on left leg later that day spreading to back, arms, eyebrows. Now subsided but small amount of welps on right leg. Rash comes and goes. Mom used hydrocortisone cream on rash as per ER recommendations. Resolving now.
Patient started with really bad leg cramps early morning next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Patient started with really bad leg cramps early morning next day after receiving 1st dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN and POTASSIUM for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Mar-2021, the patient experienced MUSCLE SPASMS (Patient started with really bad leg cramps early morning next day after receiving 1st dose). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. On 22-Mar-2021, MUSCLE SPASMS (Patient started with really bad leg cramps early morning next day after receiving 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines included Diabetic medications, Blood pressure medication, seizure medication, Cholesterol medication   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received and  Patient declined for further contact.
I was unable to sleep the night following the injection due to back and neck aches.  Several hives that appeared on my back that night and the following day may have been symptoms of an allergic reaction to the medication.
Information has been received from a certified nurse practitioner concerning a 26 year old female with no medical history, who in June 2007, was vaccinated IM with a first dose of GARDASIL (Lot# 658554/0928U). There was no concomitant medication. Subsequently, the patient experienced pain. On an unspecified the patient was vaccinated with a second dose of GARDASIL. Subsequently, the patient experienced pain. On 20-FEB-2008 the patient was vaccinated with a third dose of GARDASIL. Immediately post vaccination the patient experienced extreme pain at the injection site that was much more painful then after the first and second. The patient did not seek medical attentio. Laboratory diagnostics were performed. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested.
Pt recv vax on 11/25/98; on 12/2/98 pt exp fever (100), joint pain
shingles; Off label use; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 8th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and off label use. On an unknown date, the outcome of the shingles and off label use were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced internal shingles. The patient's physician ordered a 2nd dose to be administered earlier than recommended, which led to off label use. At the time of reporting, 2nd dose was not administered.
none-pt was given Gardasil inj instead of flu shot-pt was subsequently given flu vaccine-no reaction to either vaccine.
Pt was given Varicella ad PROQUAD, PROQUAD in error, should have been given MMR instead. Called mother 5-20-15 to check on patient and baby is doing fine.
Less than 48 hrs post vaccination, patient awoke at 1AM with heart racing at 188bpm for 10 minutes, then continued to have tachycardia or arrhythmia event for 1 hr. Patient visited her healthcare provider the morning after to report event and to be evaluated.
I started experiencing symptoms two hours after my second dose. I experienced, chills, headache and elevated blood pressure for about 6 hours following the began of symptoms. I called my dr. because I knew something wasn't right and my Dr. told me to relax,  and get some rest and alternate ibuprofen and Tylenol, if I didn't feel better within to call back so I could come in for an immediate visit. So, I went in to see my Dr. the next day and he checked my blood pressure and I told him I was still experiencing the headaches. He ordered an MRI and prescribe me some meds for Fioricet for the headaches and had me to titrate up on my BP meds. to get my BP down. The next day after that, I felt fine. Since then, I have fully recovered.
itchy huge rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy huge rash) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), ARIPIPRAZOLE (ABILIFY), CLONAZEPAM and OLANZAPINE (ZYPREXA) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced RASH PRURITIC (itchy huge rash). At the time of the report, RASH PRURITIC (itchy huge rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
Chills & Tired, went to bed at 9:00pm on 10/11/2021 Woke up at 1:15pm on 10/12/2021 with fever-100.3 and body aches, especially in lower back.  Took Tylenol 500mg-2 tablets at 1:30pm Rechecked temperature at 2:58 and now 98..7 and only slight body aches.
Patient stated she felt nausea. Later became lightheaded and had to be transported to the Emergency Department.
Pt visited for Well Exam on 10/04/22. Provider ordered Kinrix and Proquad vaccines. Pt received one vaccine that day but it was not documented in pts chart. Due to Temp excursion pt was unable to receive Kinrix. Pt's mom made appt to come back on 10/18. On 10/18, MA noted vaccine orders for Kinrix and Proquad from 10/04 listed as pending. MA administered both vaccines to pt. Prior to, mom expressed concern to MA that vaccine received on 10/04 was not on immunization record.  MA proceeded with the orders inputted by provider. Mom brought up her concerns again and MA brought it to supervisor's attention. Supervisor reviewed chart and provider called pt regarding re-administration of Proquad. Mom felt better after speaking to doctor
Headache, Nausea, Chills, Body Aches, Paleness, Tightness in Chest, Pain.
Patient under age 18 was vaccinated with Moderna 020B21A, which is a vaccine error, on 3/29/2021. He received his second vaccine  Moderna  002C21A on 4/26/2021, Troubleshooting: Neither original dose vaccinator/screener nor second dose vaccinator validated birthdate.  Unreported as error, found in data mining. He was eligible for the second vaccine per standing orders. A policy requiring vaccinators/scribes to check age was instituted shortly after his first vaccine to prevent this from occurring again.
DIARRHEA; PAIN IN NECK; LIGHTHEADEDNESS; LOWER BACK PAIN; FEVER; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 2021, the subject experienced pain in neck. On 2021, the subject experienced lightheadedness. On 2021, the subject experienced lower back pain. On 2021, the subject experienced fever. On 2021, the subject experienced nausea. On 2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102 to103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, pain in neck, lower back pain, and nausea on 2021, had not recovered from lightheadedness, and fatigue, and the outcome of fever was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
eggs smells bad like fish oil; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (eggs smells bad like fish oil) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007m20a and 024m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced PAROSMIA (eggs smells bad like fish oil). At the time of the report, PAROSMIA (eggs smells bad like fish oil) outcome was unknown.            No Concomitant medications were provided No Treatment information provided
Petechial rash started on 3/8, was all over body with some concerning brushing on 3/9 when he was seen in our office. That night went to the ED and was evaluated and diagnosed with ITP.  Treated with steroids and then discharged home. Platelet counts rebounded nicely.
Vision problems and seeing objects moving; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision problems and seeing objects moving) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VISUAL IMPAIRMENT (Vision problems and seeing objects moving). At the time of the report, VISUAL IMPAIRMENT (Vision problems and seeing objects moving) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated he saw water on the floor in kitchen moving and a statue in one of his rooms moving upwards or doubling up.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Pt found to have extensive petechial rash 9 days after receiving Tdap. Admitted for ITP to hospital.  11/21/2007 MR received for DOS 9/16-18/2007 with D/C DX: ITP.  Child with hx of ITP following vaccines in 2001 (VAERS 179311) presented with platelet count of 3,000 and petechial rash on feet and legs.  Pt had a 30 minute nosebleed which was diffficult to control. Admitted to current hospital with platelet count of 20,000. Pt reported high fever with rigors on day of tetanus booster 9/6/07 and currently c/o nasal congestion, rhinorhea, and a sore throat. Pt txd with IVIG with increase in platelets.
This spontaneous report was received from a physician assistant and refers to a 47 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 29-NOV-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 39 degrees Fahrenheit for 1008 hours (42 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
Bilious vomiting x5 since AM at ER. U.S. done in ER: ileal cecal intussusception. Transferred to another hospital and observed x24 hours - resolved.
This spontaneous report was received from the registered nurse refers to patients of unknown age and gender. No medical history and concurrent conditions reported. On an unknown date the patients were inadvertently administered with improperly stored, GARDASIL 9 vaccine, lot # K026246 exp: 28-JAN-2017 (dose, route therapy type not reported). No adverse effects reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Pt had CP and shortness of breath , dizziness started 24hr after moderna #1, 2 weeks ago now.  Treated with steroids x 2 weeks but still having pain.  Worse when lying down - Acute idiopathic pericarditis  - Primary