chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 07Jul06 from a health care professional. A 14 year old male pt with a past medical history of asthma had received his first dose of Menactra, lot number U1877AA, on 16Jun06. The route and site of administration were not reported. Reportedly, the pt had no current illnesses, and was not taking any other medications at the time of vaccination. Approx 17 days post immunization, on 03Jul06, the pt developed a fever of 102 to 104 degrees and lumbar puncture were negative. Lab work showed bilirubin 4.41, alkaline phosphatase 221, SGTP 90, SGOT 52, and CRP 9.41. The WBC's and differentials were normal. The pt had elevated liver enzymes, and tested non Hep A, B, and C. The pt was treated with unspecified antibiotics for two days. His condition improved, and he was discharged from the hospital on 06Jul06. The recovery status of the pt was reported as not recovered.
dental issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TOOTH DISORDER (non-serious), outcome "unknown", described as "dental issues". Additional information: It was reported that the reported wanted to know if patient can take pain reliever due to dental issues.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TOOK VIVOTIF WHILE ON AUGMENTIN; This spontaneous case report was received from a pharmacist (PVX2019-365) on 08-Feb-2019. The report describes a female consumer who "took Vivotif while on Augmentin". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis and Augmentin (amoxicillin and clavulanic; one daily) for an unknown indication.  It was reported that the consumer started Augmentin 21 days ago, taking it every day until today (start date: 18-Jan-2019 and end date- 08-Feb-2019). She started Vivotif 8 days ago and completed the course (start date: 31-Jan-2019 and end date- 06-Feb-2019).  The action taken with Vivotif and Augmentin with respect to the event "took Vivotif while on Augmentin" was not applicable.  The clinical outcome of the event "took Vivotif while on Augmentin" was unknown.  Company's Comment: The causality of the event "took Vivotif while on Augmentin" was considered as not applicable. ; Sender's Comments: Company's Comment : The causality of the event "took Vivotif while on Augmentin" was considered as not applicable.
PT RECEIVED FIRST J AND J VACCINE ON 4/21/21 AT THE DRUGGIST AND RECD A PHONE CALL NEXT DAY FROM THE DRUGGIST STATING THEY HAD BEEN GIVEN EXPIRED MODERNA VACCINE INSTEAD. DR CONSULTED AND OK TO RECD J AND J SINCE 2 WEEKS HAD PASSED. PT RECD J AND J VACCINE TODAY.
TESTED POSITIVE AGAIN; This spontaneous report received from a consumer via a company representative concerned a 31 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced tested positive again. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive again was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000218982 This case, from the same reporter is linked to 20220256345.
A few minutes after receiving the vaccine, his older brother fainted and within a few minutes after that patient fainted as well. Patient went pale, pupils dilated and though eyes remained open, patient was unresponsive for about 10 sec. After a few minutes in Trendelenburg, color returned and patient went back to normal.
This spontaneous report was received from a pharmacist regarding an 88 year old female patient. The patient's medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On 21-MAR-2017, the patient was vaccinated in error with an expired dose of ZOSTAVAX vial 19400 Plaque-forming unit (PFU) (dose was not reported) subcutaneously (lot number: L037791; expiration date: 30-DEC-2016) for prophylaxis. The patient was also administered sterile diluent injection (strength and dose were not reported) subcutaneously (lot number: L035498; expiration date: 01-MAY-2018). Additional information has been requested.
Patient received 0.5ml of Moderna Booster Vaccine instead of the CDC recommended 0.25ml
When the pharmacist gave me the shot, it felt like I had been punched in the arm.   My right arm has been sore and felt bruised since that night.
slight swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (slight swelling at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (slight swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (slight swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Chills and Fever (101) started on Dec. 04, 2009.  Then had fever of 102 from Dec. 5 through Dec. 7, 2009. Other symptoms: nausea, loss of appetite, weight loss. No respiratory symptoms noted.
swollen throat; Her doctor diagnosed that it was an allergic reaction to the vaccine.; weird sensation while swalloing; Reflux; Sporadic sharp pain in the tip of the tongue; This spontaneous case was reported by a patient and describes the occurrence of PHARYNGEAL SWELLING (swollen throat) and ALLERGY TO VACCINE (Her doctor diagnosed that it was an allergic reaction to the vaccine.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included LISINOPRIL for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (swollen throat) (seriousness criterion hospitalization), ALLERGY TO VACCINE (Her doctor diagnosed that it was an allergic reaction to the vaccine.) (seriousness criterion hospitalization), DYSPHAGIA (weird sensation while swalloing), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and GLOSSODYNIA (Sporadic sharp pain in the tip of the tongue). The patient was treated with CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency; MONTELUKAST at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROXYZINE at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (swollen throat), ALLERGY TO VACCINE (Her doctor diagnosed that it was an allergic reaction to the vaccine.), DYSPHAGIA (weird sensation while swalloing), GASTROOESOPHAGEAL REFLUX DISEASE (Reflux) and GLOSSODYNIA (Sporadic sharp pain in the tip of the tongue) 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.   Concomitant medications include birth control pills.  Treatment medications also include d18 days with IV corticoids and other days orally.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse refers to a 1 year old male patient. On 21-JUL-2014 at 06:30 PM the patient was vaccinated with the first dose of VARIVAX (Merck) lot # J012773 expiry date 09-OCT-2015, subcutaneous in the left arm. On 21-JUL-2014 at 06:30 PM, concomitant vaccines included M-M-R II and PREVNAR. VARIVAX (Merck) was improperly stored. No adverse symptoms reported. This is one of four reports received from the same reporter. Additional information is not expected.
Received Adacel and Menactra vaccines on 7/31/07 prior to college admission.  Treated for upper respiratory infection on 08/28/07 with cefaclor per urgent care.  Developed Bell's Palsy on 08/31/07.  Treated in ER with prednisone.
Patient came to store 325 on 11/07/2022 around 2:30pm to receive his Moderna Bivalent and Fluzone HD vaccines. He claims that the vaccines were administered in the incorrect area of his arm. He said he went to his doctor as well and the doctor said the same thing. He came in the store around 12:15pm on 11/16/2022 to report the incident to store management who then escorted him to the pharmacy to make use aware of the complaint. The Pharmacy Manager, Operation Specialist, and Pharmacy District Manager were all informed and the incident report was fi led. No monetary reimbursement was provided. The patient stated that the vaccines were correct but they were just given wrong causing him nerve damage in his arm to where he can "barely move it or tie his shoes".
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated unknown doses of improperly stored GARDASIL 9 (dose, frequency and route were not reported, data logger was involved), lot # was reported as 1024993 with expiration date 17-OCT-2017. The GARDASIL 9 was improperly stored at 9 centigrade for 30 hours and then back in range. No adverse effects were reported. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine administered 08/28/01. Came to the Health Dept again on 08/30/01, wanting a doctors excuse, says "can't move arm", "swollen", no "feeling in arm and shoulder". No visible swelling, no local reaction resides holding forearm bent. Sent to PMD.
I had neck stiffness, Shoulder (both) pain and weakness, Elbow (both) stiffness and pain, sharp pains in both arms. I had my 2nd and last Moderna booster on Nov 17 2022. I had almost never ending symptoms that just went totally  away on May 16th 2023. I changed nothing in my daily meds, diet or  anything else to make my symptoms go away.
ATC Vaccination Services was operating a COVID vaccination clinic . On 6/10/21 it was discovered that Lot # EW0186 was removed from the freezer on 6/4/21 (lot expiration date was 8/31/21). The CDC,  Department of Health and Pfizer hotlines were consulted by the lead nurse at the site and informed that the vaccine was to be in the freezer no longer than 14 days. The vaccine arrival log was checked and showed the vaccine was to be in the freezer until 5/14/21. The vaccine was administered to 899 individuals during the period of 6/5/21 to 6/9/21. All patients were attempted to be contacted. A list of patients, their date of birth and contact information. No side effects were reported when patients were contacted.  NYC Department of Health, NYCEM Plan Revision/Vaccine Operations provided the script with which to contact the patients and advise them of what happened and that they should get another dose of the vaccine. An email was also sent to the patients. The remaining doses of the lot number involved were wasted.   I am making this report in good faith based on information provided by healthcare professionals that were at the vaccination clinic. All records, dates and care was provided by clinical staff at the vaccination site on the applicable dates.   , RN
Swelling, redness, could not use arm for 2 days, missed 1 day work, fever, chills for 24 hours, Treatment ice packs.
Clt. seen in clinic, received Tdap & TWINRIX vaccine on 10-11-11 called & reported pain, tingling, numbness on 10-19-11. Advised on use of cold & hot compresses; ibuprofen & BENADRYL and moving arm. Saw MD on 10-20-11 & was told had large hematoma pressing on nerve - to continue hot compresses, exercising arm & pain meds. Bruise occurred 1 wk after injection, still painful.
sore arm/I woke up in the middle of the night and I had pain in the arm; Headache; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiration Date: 31May2021), dose 2 via an unspecified route of administration on 03Feb2021 04:00 as 2nd dose, single dose for covid-19 immunisation. Patient took ibuprofen (ADVIL [IBUPROFEN]), via an unspecified route of administration from an unspecified date to an unspecified date, (I took Advil this morning two) for an unspecified indication. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) for covid-19 immunization on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced sore arm/woke up in the middle of the night and had pain in the arm, headache. Now confused because some people say don't take anything before or after, so you don't lessen the effectiveness of the vaccine, was told yesterday that could take Advil or Tylenol if I needed today. So, want to know is the answer, can take something. Patient received treatment of advil this morning too. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
HEART RATE WAS WAY HIGH; ARM NUMB FROM ELBOW TO FINGERTIPS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart rate was way high, and arm numb from elbow to fingertips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm numb from elbow to fingertips, and the outcome of heart rate was way high was not reported. This report was non-serious.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information was provided on medical history and/or concomitant medications. On 31-JUL-2012 the patient was vaccinated with PNEUMOVAX23, and was mistakenly vaccinated with another dose of PNEUMOVAX23 on 08-OCT-2013. Lot number(s), route of administration and action taken were not provided. No adverse effects reported. Additional information has been requested.
4cm erythematous indurated skin rxn devel approx 8-10hr p/vax; pt c/o felt tingly all over;
Burning red rash 3? X 2.5 ? raised like a giant hive. With several small 1? hive like circles also raised.   Very red Very itchy Rough and raised   Nothing else going on. No fever not feeling ill. Never experienced this type of reaction before to any  flu injection.  BUT DID HAVE SIMILAR REACTION TO ANTHRAX VACCINE IN 2006 to 2007.   Otherwise feeling fine.   Duration of rash so far 3 days and getting bigger.
This vaccine was given 4 days past the BUD (6/23/22).  Moderna was contacted and the lot was analyzed.  Per Moderna this lot was still active and patient did not need to be revaccinated.
Silver dollar sized raised and itching spot around injection site - told her to use cold compress and take BENADRYL.
This spontaneous report as received from a physician refers a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route were not reported) lot # L002213, expiration date 21-JUL-2016. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
7 days after vaccine, patient developed redness, swelling and itching at left deltoid to just above left elbow.  also itching around mouth. she took benadryl 3 times a day and finally had improvement of symptoms.  No dyspnea, dysphagia.
Information has been received regarding a case in litigation, from a lawyer, regarding a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 15-DEC-2015 (reported as on or about 15-DEC-2015), the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the health provider. On unknown date, the patient experienced shingles (herpes zoster) and on 11-DEC-2016 (reported as on or about 11-DEC-2016), the patient was treated for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) and suffered serious physical, emotional, and economic damages, as a result of patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffered (emotional distress, pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (quality of life decreased and condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The reporter considered all aforementioned adverse events to be related to ZOSTAVAX. The reporter considered the events to be disabling, life-threatening and medically significant.
VACCINE EXPOSED TO TEMP OUTSIDE OF REC STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.
Pt recvd 3 doses of Engerix-B, 3rd given 20NOV90; 19FEB91 titers indicated no seroprotection p/3 doses; 4th dose given 22APR91; 5th dose given 17MAY91;
Pt arrived to the ICU from the Hospital post arrest and in DKA. Pt was also found to be COVID positive, and brother that she lives with is also COVID positive.
Tremors (could not walk, lost sight in both eyes, Extremely high BP (220/110), Could not breathe (put on ventilator in ICU), Found blood in brain) Fluid built up in lungs.  All over 4 1/2 days starting on 05/08/2021
Patient received wrong vaccine for her age. Patient has no adverse event. She is well and her primary doctor is closely monitoring .
This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On 13-NOV-2013 the patient was indicated to be vaccinated with PNEUMOVAX 23 may have received a dose of vaccinated with ZOSTAVAX, 0.5 ml, intramuscular in the right arm. This was reported to be a possible documentation error and not product confusion. No adverse effect reported. No other information was available. Additional information has been requested.
Individual developed a maculopapular rash at the varivax injection site, on 5/25/2009.
This spontaneous report as received from a pharmacist refers to an unknown age and gender patient. on 26-JUN-2013 the patient was vaccinated with less than a full dose of ZOSTAVAX (lot# unspecified), formulation and route unspecified, (dose and frequency unspecified) due to a syringe leakage. No adverse symptoms reported. Additional information has been requested.
right eye swelled up; Itchy all over; could not breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old patient received BNT162b2 (BNT162B2), on 23Sep2021 as dose 2, single (Lot number: FC3184) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FC3184; Anatomical location: Arm Right), administration date: 31Aug2021, when the patient was 49-year-old, for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 23Sep2021 at 01:45, outcome "recovered with sequelae", described as "Itchy all over"; DYSPNOEA (non-serious) with onset 23Sep2021 at 01:45, outcome "recovered with sequelae", described as "could not breathe"; EYE SWELLING (non-serious) with onset 23Sep2021 at 01:45, outcome "recovered with sequelae", described as "right eye swelled up". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of eye swelling, pruritus, dyspnoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not  received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The report was not serious.
I'm a healthy 32 year old female who has been experiencing bleeding for 2 1/2 weeks now, fatigue, and excruciating cramping after the second dose of Pfizer vaccine shot. I had to go to my OBGY in order to  help me in stopping the bleeding and cramping , in which I couldn't get out of bed, she has put me on Naproxen Sodium 550mg twice a day. I am still bleeding though.