chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was retrieved via a search of scientific literature on 14 November 2011. The reporter for this case is the same as for case numbers 2011-11217, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11225, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results: CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 22 year-old patient (gender not reported) with a history of asthma had received on an unspecified date YELLOW FEVER VACCINE (manufacturer, lot number, route and site of administration not reported), TYPHOID VACCINE (manufacturer, lot number, route and site of administration not reported), DIPHTHERIA AND TETANUS TOXOIDS (manufacturer, lot number, route and site of administration not reported) and HEP A (manufacturer, lot number, route and site of administration not reported) and one day later developed Yellow Fever viscerotropic disease. The event was determined to be definitely related. No further information was available at the time of the report. The outcome was not reported. Documents held by sender: None.
RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 44 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26.cov2.s from unspecified manufacturer (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported, 1 in total administered for prophylactic vaccination (dose number in series 1). It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, 1 in total, administered on left arm on 01-DEC-2021 for prophylactic vaccination (dose number in series 2) which was an off label use as patient received less than 0.5 ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose).   No concomitant medications were reported. As per the report, the health care professional (HCP) withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5 mL but the caller mentioned that the math (she arrived at that by dividing 2.5 mL by 5 doses) did prove that they received approximately around 0.3 mL.(dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received less than 0.5ml (approximately around 0.3ml) of vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211210067, 20211210058, 20211209551, 20211209679, 20211209706, 20211209740, 20211209782, 20211209798, 20211209816, 20211209874, 20211209884, 20211209912, 20211210019, 20211210058, 20211209921, 20211210588, 20211210610, 20211210159, 20211210555, 20211210408, 20211209880, 20211210133, 20211209775, 20211212088, 20211212082, 20211210670, 20211210824, 20211210160, 20211210350, 20211210141, 20211210585, 20211210107, 20211210180 and 20211210385.
Fell; Broke ankle; Received 1st dose about 30 days ago; unsure when will receive her 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of FALL (Fell), ANKLE FRACTURE (Broke ankle) and PRODUCT DOSE OMISSION ISSUE (Received 1st dose about 30 days ago; unsure when will receive her 2nd dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (Fell), ANKLE FRACTURE (Broke ankle) and PRODUCT DOSE OMISSION ISSUE (Received 1st dose about 30 days ago; unsure when will receive her 2nd dose). At the time of the report, FALL (Fell) and ANKLE FRACTURE (Broke ankle) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Received 1st dose about 30 days ago; unsure when will receive her 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.
Continuous itching at the site since symptoms first began.   It is still itching 1.5 days since I received the shot.  There is no swelling or redness.
PCOS (diagnosed roughly 2 years after the shot), IBS, Obesity/rapid weight gain right after the shot, Muscle Spasms, Constant Diarrhea started after getting the first shot and last for 2+ years,  Blurry Vision/Dizziness, Insomnia, Depression, Joint Pain, Seborrheic Dermatitis (covered my face and body within weeks of receiving the first shot and worsened with each shot, went to dermatologist, none of the treatment work and was just extremely painful), Occasional Numbness in Legs, Painful Rashes, and Frequent Gallbladder Attacks for 3+ years/Cholecystitis. It?s been over 7 years and I still suffer with the PCOS, obesity, numbness, muscle spasms, insomnia, dermatitis, rashes, insomnia, depression, blurry vision and dizziness, and joint pain. All of these things happened very quickly after the first shot and became exacerbated by the last two. Never understood why my health took a turn so quickly when I was just a healthy kid who played outside all the time.
2 hours after getting the vaccine I started getting the full body pain and headaches. The headaches lasted until I got migraine medication which was last month. After first dose, I had severe migraines, my eyesight in my left eye was starting to get blurry and my eyeball hurt and they found hemorrhages my left eye and diagnosed me with migraines. I went to the hospital before getting the second dose because I had severe kidney pain. My kidney results came back fine but they could see that my kidney was swollen. My legs started getting swollen too. I was worried because I had kidney stones the year before and it felt like I was getting them again. I am going to see an allergist because I have a rash from head to toe that comes and goes.
Itchy throat. Was observed by EMS , able to take but had no difficulty breathing or speaking. Able to walk to own car without assist. No further eval required but was advised to contact EMS or PCP if symptoms reappeared.
pt experienced redness, throbbing pain at injection site. She also noted that the injection was given at a higher area than her previous dose. She took 1 tablet of APAP the evening of the vaccination. I recommended for her to use ice and continue with APAP as needed and will follow up with us
This spontaneous report was received from a Medical assistant referring to 3 patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported.  On an unspecified date in AUG-2016 (reported as 02-AUG-2016 or 03-AUG-2016) the patients were vaccinated with improperly stored VARIVAX. Concentration, dose and route of administration were not reported (lots # M000757 and L020002, expiry date 06-FEB-2018 and 02-JAN-2016  respectively). It was reported that the temperature excursion was for 9 hours at 9 F, according to the data logger. There was no previous temperature excursions. No symptoms were reported. Additional information has been requested.
He received vaccine 11/11/15 and called 11/13/15 to tell us that his arm became red, inflamed, and hard to touch. Advised patient to take BENADRYL to alleviate reaction and to contact PCP to let them know about rxn.
Left arm and shoulder sore and numb x 2 weeks, used ibuprofen w/ relief, no redness, pt limited activity.
Bladder infection; High fever; Cough; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0177), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He stated that the reason he called was he supposed to get a second shot on Monday and he have a bladder infection, high fever 2 days ago and cough. He is not sure if I should get the second shot right now. The patient received treatment due to the bladder infection with Cephalexin. The outcome of events was unknown.
Provider prescribed a Twinrix vaccine to this patient 01/06/2023. Patient picked up vaccine at Pharmacy. Patient brought vaccine to MA to administer to patient. MA gave vaccine with out  checking  experation date on vaccine . Vaccine expired 01/01/2023. They  went to pharmacy spoke with pharmasist about expired vaccine  TWINRIX. Pharmacist called manufacturer in regards to the expired vaccine. Manufacturer stated vaccine is valid 30 days after experation date. Medical Director made aware of error.  MA made provider aware also made patient aware.
This is a spontaneous report obtained from a contactable consumer through a Pfizer sales representative. A 19-year-old female patient received, on 21Aug2015, the first dose of TRUMENBA single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Aug2015, one or two hours after the vaccination, the patient experienced severe pain, induration, swelling and crying. The patient took ALEVE for the pain. Clinical outcome of the events was unknown at time of this report. Follow-up (22JAN2016): Follow-up attempts are completed. No further information is expected.
Patient stopped into pharmacy to report a painful shoulder and an inability to lift her arm after receiving her seasonal influenza vaccine. Patient states her pain has gotten progressively worse and spoke to her doctor about the issue. She said she can't lift her arm at all. She referenced a potential torn rotator cuff, but is undergoing an MRI in 2 weeks (around 10/31/21) to determine the extent of her ailment if her condition does not improve.
expired  5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired  5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported.  Reporter stated that Moderna vaccine pulled from freezer 16 Dec 2021, BUD date of 15 Jan 2022 printed in red and taped to the top of the boxes. On 26 Jan 2022, staff brought it to attention that it was still in the fridge and expired and 5 doses had been given. On 31 Jan 2022, responded that revaccination was not required.  No treatment information details were reported.
pt was beginning the Hep B vax as a new employee;had never had this series before;reported to work p/inj & soon began breaking out in a rash all over;MD dx urticaria & tx w/DPH;
I had lesions on my body from my neck to my toes; Date 04Jun needed it/ 1st dose date 11Mar2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2021 as dose 2, single (Lot number: EP7533), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DUPIXENT. Vaccination history included: BNT162b2 (Dose: 01, Time: Hospital, Anatomical Site of Injection: Arm, Batch/Lot number: EN6207), administration date: 11Mar2021, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Jun2021, outcome "unknown", described as "Date 04Jun needed it/ 1st dose date 11Mar2021"; SKIN LESION (non-serious), outcome "not recovered", described as "I had lesions on my body from my neck to my toes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin lesion.  Additional Information: The patient's life has been destroyed for about 1 year. Had lesions on body from my neck to my toes. Tons of creams burning off, cortisone shots and nothing helps. Just started Dupexent (On 2nd shot). Nothing still happening  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201224766 same patient/product, different dose/events;
Chills, fever, migraine like headache for 3 days, sensitivity to  light, flu like symptoms.  Unable  to work for 3 days and still not feeling well until 3/20/21 which was almost a week after the second shot.   Got really dehydrated and had muscle aches.  Actually went for a covid test which was negative.
Information has been received from a registered nurse and a mother of a student concerning another child in elementary school who was vaccinated with a dose of Varivax. It was reported that the patient now has breakthrough chickenpox after an outbreak occurred in the elementary school. Unspecified medical attention was sought. No product quality compliant was involved. Follow-up information from a health professional indicated that the index case was an unimmunized individual. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
I noticed rash at base of spine followed shortly by bouts of diarrhea that lasted 12 days. The rash spread all over my trunk, then down my thighs. I still have it although it is fading. Bouts of diarrhea got worse the second week but are intermittent now.
HYPOTENSION ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY CARDIOGENIC SHOCK 3/2/2022 &  7/13/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Vice like headache, heart rate increased, dizzy light headed. Weak, earring, stiff neck. I have had this for now 11weeks since first dose. Was healthy prior to shot.
20 minutes post vaccination at 17:05 upon walking out with son, patient felt dizzy. Initial evaluation was rapid regular tachycardia at 150, BP stable, systolic 140, 96% O2 SATS RA. EMS called at 17:25 when patient not improving; ECG showed rate of 106, sinus tachycardia. Poor R-wave progression. No acute changes of ischemia. After discussing options, initially son decided to take his mother home, but she began having dizziness and feeling poorly again with return of SVT. Transported to ED by EMTs. Observation for a few hours in the hospital and discharged home. Follow-up call on 12/29/2021 reveals patient doing well with no recurrence of symptoms.
Developed chest discomfort that happened only when sitting or laying down, Treated for Pericarditis. with Indomethicin for one week, Cholchine for three months. Still being treated, symtoms improving.
This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 41-year-old female patient who received FLUARIX quadrivalent (batch number 7994K, expiry date 16th June 2016). On 24th September 2015, the patient received the 1st dose of FLUARIX quadrivalent (intramuscular) .5 ml. On 24th September 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was recovered/resolved. The reporter considered the local swelling to be possibly related to FLUARIX quadrivalent. Additional details were provided as follows: The patient experienced red bumps (local swelling) on her upper torso following the administration of FLUARIX QIV vaccine. The bumps lasted for 5 or 7 days.
7 days post shot, swelling and heat at injection site. Itching and visible rash accompanied by extreme tiredness a s body aches
Info has been received from a nurse concerning her daughter with no medical history who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, between 2-6 years old, she developed chicken pox. No labs were done and the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. The child's brothers had similar experiences after vaccination with varicella virus vaccine live. Additional info has been requested.
Upper arm pain - shoulder and neck within one hour of flu vaccine being administered. Duration of 24-36 hrs. Ibuprofen and ice as treatments.
vaccine administered in the left hip due to their timed-release 7 day patches applied on their upper arm; normal soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine administered in the left hip due to their timed-release 7 day patches applied on their upper arm) and MYALGIA (normal soreness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No medical history was given.  Concomitant products included BUPRENORPHINE, MORPHINE, IBUPROFEN (MOTRIN CHILDREN) and MENTHOL (BIOFREEZE [MENTHOL]) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine administered in the left hip due to their timed-release 7 day patches applied on their upper arm) and MYALGIA (normal soreness). The patient was treated with IBUPROFEN at an unspecified dose and frequency and MENTHOL (BIOFREEZE [MENTHOL]) at an unspecified dose and frequency. On 06-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccine administered in the left hip due to their timed-release 7 day patches applied on their upper arm) had resolved. On 08-Apr-2021, MYALGIA (normal soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications included over the counter pain medications. Treatment medications include pain patches, prescription pain medications and pain killers.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non Significant Followup was received.
EXHAUSTION WITH VOMITING.  MUSCLE ACHES.  HEADACHE IN LEFT SIDE OF HEAD.  RINGING IN EARS.  TINGLING IN LEFT LEG.  BLURRED VISION TEMPORARILY.
Same as what I reported after 1st dose of Pfizer vaccine.  103 degree fever, blood vessels felt like they were constricting which resulted in severe chest pain. Additionally, throbbing pain behind my right knee. Also, had pain in my eyes, gums, and toes.
Patient received HIGH DOSE FLUZONE in left arm and PNEUMOVAX 23 in the right. Upon awakening this morning, her arm was red, swollen, and hurt to use. She went her healthcare provider and he prescribed CIPRO and prednisone.
Case number PHEH2014US022792, is an initial spontaneous report received from a consumer on 10 Nov 2014. This report refers to a female patient of unknown age. Reporter used to write a newspaper column and one woman responded to a column about flu vaccine. She was vaccinated with influenza vaccine (manufacturer and batch number unknown) on an unknown date. The woman "almost died" from the flu shot. Outcome of the event, seriousness and causality assessment was not reported. Seriousness assessment of almost died was upgraded based on information available in the source documents. No additional details available.
VOMITING, COUGH, FEVER, CHILLS, BODY ACHES, NAUSEA
This spontaneous report was received from a certified pharmacy technician refers to a patient of an unknown age and gender. The patient's relevant medical history and concurrent condition were not reported. On 07-APR-2018, the patient was inadvertently vaccinated with an expired dose of M-M-R II injection, lot#M011166 (expiry date: 31-MAR-2018), subcutaneous left arm for prophylaxis (dose not reported). Concomitant therapy included ZOSTAVAX; and sterile diluent (MRK) which was reconstituted with M-M-R II. The patient was in a 30 day period of expiration. The patient felt fine after vaccination, no adverse effect/ illness at the time of vaccination reported. No treatment was given for the event. No product quality complaint (PQC) was involved. There was no temperature excursion as a result of a reading from a digital data logger. Lot number [M011166] is an invalid lot number for M-M-R II.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, expire date and route not reported). Physician stated that on an unspecified date after getting ZOSTAVAX (Merck), the patient experienced a neuropathy in her face. The patient sought unspecified medical attention. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Tansient Ischemic Attack--not able to move her arm returned to work the following day didn't visit physician or hospital
5/3 Headache started that evening. 5/9 worsening headache, beginning rash. RX Vicodin and Zyrtec. 5/9 later -went to ER - Had CT of Brain, RX IV Benadryl 5/11 back to ER for HA, had spinal tap.