chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.  Diluent was not involved in the temperature excursion.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQU; This spontaneous report was received from a nurse and referred to a 12-month-old-female patient. Concomitant medication included sterile diluent. The patient's has a history of asthma and seasonal allergies. The only medication is seasonal allergy medication (no specific type provided). The patient's concurrent condition was not provided.   The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was improperly stored during a supported temperature excursion. Temperature was 7 Fahrenheit degree (F). Time frame was 1 hour 37 minutes. Previous temperature excursion did not occur. Sterile diluent was not involved in the temperature excursion. On 16-MAY-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (1 dosage form, lot # was reported as W024980, expiration date was reported as 05-FEB-2024 anatomical location was left thigh) intramuscularly for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).
Pt received shingrix in left deltoid then complained of pain then pt complained of dizziness a few minutes later. Pt then stated she could not breathe and a code was called. Pt was turning grey and diaphoretic. Pt received epinephrine per doctors orders, oxygen and legs were elevated. Pt vitals were in the low 40s and 30s, oxygen was in the 80s and blood pressure was 100/50 and pt was unresponsive. After pt received the epinephrine her vitals started to come up and she became responsive.
This spontaneous case reported by a consumer, describes the occurrence of ageusia (I am having an issue about tasting my food I can't taste it well) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced ageusia (I am having an issue about tasting my food I can't taste it well). At the time of the report, ageusia (I am having an issue about tasting my food I can't taste it well) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not reported.
INTERCHANGE OF VACCINE PRODUCTS; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE PRODUCTS) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE PRODUCTS). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE PRODUCTS) had resolved. Not Provided          No treatment information was provided by the reporter. No Concomitant medicines were reported. Patient had taken Pfizer as one of the COVID-19 immunization doses and patient wanted to know what to take as booster dose  either Moderna or Pfizer .
Developed face and neck urticaria 11 days after Moderna vaccine.  No other identified triggers.  No prior history of urticaria or allergies.  Standard treatment for urticaria with antihistamines, advised to get second COVID-19 as normally recommended.
WALNUT SIZED, WARM LUMP AT INJECTION SITE; TENDERNESS ON HER ARM; SEVERE CHILLS; PAIN AT INJECTION SITE; SWELLING AT INJECTION SITE; FEVERISH; SICK FEELING FOR 2-3 DAYS; WARMTH AT INJECTION SITE; BRUISING TO INJECTION SITE; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 190 pounds, and height was 62 inches. The patient's past medical history included: esophageal narrowing, and concurrent conditions included: hay fever, cats allergy, allergy to environmental, and pre-osteoporosis. The patient experienced drug allergy when treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-JUN-2021, the patient experienced warmth at injection site. On 04-JUN-2021, the patient experienced bruising to injection site. On 04-JUN-2021, the patient experienced sick feeling for 2-3 days. On 04-JUN-2021, the patient experienced severe chills. On 04-JUN-2021, the patient experienced pain at injection site. On 04-JUN-2021, the patient experienced swelling at injection site. On 04-JUN-2021, the patient experienced feverish. On an unspecified date, the patient experienced walnut sized, warm lump at injection site, and tenderness on her arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warmth at injection site, bruising to injection site, and pain at injection site, and sick feeling for 2-3 days, severe chills, and feverish on JUN-2021, had not recovered from walnut sized, warm lump at injection site, and tenderness on her arm, and the outcome of swelling at injection site was not reported. This report was non-serious.
This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 52 year-old male patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 30/40 which was not suggestive of malingering (<6). The patient was diagnosed with mild mircosmia (18th percentile). The PEA (phenyl ethyl alcohol) test score was -3.62 bilateral. The Whole-Mouth test identification test score was 93% correct. The outcome was not reported. Reporter's comments: The authors reported that this was a rare occurrence in an adolescent individual. The smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
This spontaneous report was received from a Licensed Practical Nurse (LPN)referring to a female patient of unknown age. The patient's pertinent medical history, current conditions and concomitant therapies were not provided. On 17-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II (lot # K021952, expiration date 10-NOV-2016) subcutaneous. No adverse effect was reported. No further information was provided. Additional information was requested.
This spontaneous prospective pregnancy report was received from a 38 year old female patient who was also a physician assistant. The patient did not have drug Reactions/Allergies and concomitant medications. Medical history and concurrent conditions were not reported. On 21-MAR-2018, the patient was vaccinated with VARIVAX (lot and expiry date not reported) as a job requirement because her varicella titers were low and she had no record of previous varicella vaccination. The day after vaccination (22-MAR-2018), the patient took a home pregnancy test that was positive. The patient said she was 4 weeks pregnant and her last menstrual period occurred on 21-FEB-2018. The date of conception was 07-MAR-2018 and the estimated due date for delivery was on 28-NOV-2018. The patient said that she had not seen a physician and said that she currently did not have a physician. No adverse clinical effects were reported.
At 16:00 on 10/06/2003, patient noticed soreness in left arm.  About 20:00 she noticed left arm was warm to touch and swollen.  Unable to sleep off discomfort of arm.  Today 10/07/2003, evident edema from just above anticubital space extending to about 6 inches below left shoulder.  Generalized redness and warmth.  No lumps, knots, or bruises noted.  Able to use left hand.  No numbness or tingling noted.
Pfizer-BioNTech COVID-19 Vaccine: Within fifteen minutes of vaccination patient reported chest and facial flushing , mild facial swelling, and feeling of heart racing. Initial vital signs: blood pressure 117/58 mmHg, pulse 91 beats per minute, and oxygen saturation 97% on room air. Patient administered oral diphenhydramine 50 mg once and observed for a total of one hour from vaccine administration during which symptoms improved. Vital signs were checked every five minutes and remained within normal ranges during entire observation period. Patient given water and juice and left in stable condition.
This spontaneous report was received from a healthcare worker refers to multiple unknown patients of unknown age and gender. Medical history, concurrent conditions and concomitant medication were not reported. On multiple unknown dates, patients were vaccinated with improperly stored (temperature: 1.3C, for 1 hour and 30 minutes, because of a "data logger") GARDASIL 9, lot # M005714, exp: 03-OCT-2017; lot # M004116, exp: 12-OCT-2017; lot # L045711, exp: 08-MAY-2017; lot # L048459, exp: 22-FEB-2018; lot # M007728, exp: 21-MAR-2018, (dose and frequency not reported). No adverse effects were reported. No previous temperature excursion was reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
After receiving the first Moderna vaccine on Feb 24, 2021,  I noticed that my toes started to turn purple sporadically.  Aproximately 14 hrs after receiving the 2nd Moderna Vaccine I experienced a SEVERE pounding headache and SEVERE muscle pain especially lower back no relief after taking NSAID's or Tylenol.  Non stop sever pain for 24 hrs.  Discoloration purple toes still persistent. Extreme fatigue and no appetite. 72 hrs after 2nd dose of Moderna still very fatigue. Sever pounding headache and severe muscle pain gone.
This spontaneous report as received from the patient's grandfather refers to a 1 year old female patient with no allergies or drug reactions history. On 13-MAR-2015, the patient was vaccinated with a dose of MMR II, subcutaneous (dose, lot # and expiration date were not provided). On 13-MAR-2015, the patient experienced muscle tightness. At the time of the report the outcome of muscle tightness was reported as recovered. The patient subsequently experienced an underdose while she was vaccinated with (Oka/Merck) VARIVAX (MARRS 1503USA008473). This is one of several reports received from the same reporter. Additional information has been requested.
patient woke up at 3 A.M 10/18 the morning after her vaccination and had a rash in her groin area, she had called the pharmacy about the rash and we told her to take a Benadryl and call us back if it got worse, she called back and the rash had started to spread up her stomach and on her arm and her tongue was swollen. I told her to call her primary, they had her come in and gave her two shots (she was not sure what they both were (maybe a steroid) to help with the reaction).  She said it is getting better.
This is a spontaneous report received from contactable reporter(s) (Other HCP). A 52 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "breast cancer" (unspecified if ongoing); "difficulty remembering" (ongoing); "multiple sclerosis" (ongoing). Concomitant medication(s) included: Ocrevus; Colecalciferol; Vitamin B Complex. The following information was reported: PAIN IN JAW (non-serious) with onset 06Jun2021, outcome "recovered", described as "her jaw hurt from being so cold". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
slight headache next morning with more achiness in injection site than previous dose.  By next afternoon, terrible headache - to the point my hair felt like it was throbbing; overall body aches and extreme tiredness and chills with nausea.   all resolved by second day after the vaccination.
Two months after dose 4 of the Moderna Vaccine, I started feeling lethargic on 6/20/2022, so I took a Home Covid test and tested positive. Went to my Dr the next day and was tested for Strep, Covid and for the Flu, I only tested  positive for Covid. My Dr. gave me a choice of taking a pill (antiviral) or using an IV in the hospital. Since I have a problem with pills, I chose using the IV, however it would've be 4 more days until I could get in to the hospital to have it done. I started feeling a little better, so I decided now to have it.
Systemic: Dizziness / Lightheadness-Severe, Systemic: blacked out immediately post vaccine administration (1-2 min)-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: PT stated passing out post vaccine is normal / occurs (why he used nasal flu shot in 2020 and not injection).  blacked out post vaccination, RPh held patient at head and shoulders in chair to prevent fall from chair or injury to neck when as when he blacked out he fell back in his chair.  post black out we provided water and monitoring. PT stated during recovery light headed, tingling in fingers / numbness. vision impared (like post concussion when hit in head/face).
Patient had swelling in her collarbone area and she went to her doctor and the doctor ordered an ultrasound which indicated she had severely swollen lymph nodes.
Profound weakness, shortness of breath, saddle pulmonary embolism diagnosed by CT angiogram at healthcare facility on 4/.5/2021.
still got the flu; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced still got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, strength, formulation was unknown)  via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious still got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu).  At time of reporting, the outcome was Unknown for the event still got the flu.
Swollen neck, swollen throat top and bottom, painful throat, hard to breathe, light headed,  weak.  Over the course of 55 minutes.
Massive Heart Attack. Was given stent and Dr believed the injection possibly pushed me over the edge with blockage
"rash" on L arm @ site of vaccine, like a "pimple" with small dots around it, also same rash on both legs.  Slight fever.
About 30 minutes after dose he passed out and had a seizure that lasted 10 -15 seconds. This happened a couple times. He went to hospital had low blood pressure and oxygen. He stabilized and was released. He has a follow up appointment with his primary care doctor.
Pt c/o pain. Blacked out. Voided on herself and came to within 30 seconds.
she was not feeling well; she had chills which woke her up all night; she had chills which woke her up all night; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she was not feeling well), MIDDLE INSOMNIA (she had chills which woke her up all night) and CHILLS (she had chills which woke her up all night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MALAISE (she was not feeling well), MIDDLE INSOMNIA (she had chills which woke her up all night) and CHILLS (she had chills which woke her up all night). On 12-Mar-2021, MALAISE (she was not feeling well), MIDDLE INSOMNIA (she had chills which woke her up all night) and CHILLS (she had chills which woke her up all night) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment medicines were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-048160, MOD-2021-041860, MOD-2021-054920 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Follow up received on 22 Mar 2021 and contains no new information and  Dates of events were reported one day earlier. Kept dates from original report; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048160: MOD-2021-041860:Mother's Case MOD-2021-054920:Father's Case
PT STATES A FEW DAYS AFTER IMMUNIZED, SHE BEGAN TO NOTICE SMALL ITCHY AREAS CONTAINING 2 INDIVIDUAL DOTS IN VARIOUS AREAS MAINLY ON FOREARMS AND LEGS.  ONCE SHE WOULD SCRATCH THEM, THEY WOULDNT ITCH ANY LONGER AND WOULD TAKE 4-5 DAYS TO CLEAR UP. SHE DID HAVE ONE APPEAR ON HER FOREHEAD, ONE ON HER BREAST, BUT MAINLY ON ARMS AND LEGS. PHARMACIST ADVISED HER TO TREAT ITCHING WITH BENADRYL SPRAY OR HYDROCORTIZONE.  IF IT CONTINUED, SEE HER DR FOR DIAGNOSIS.
pt recv vax & devel an earache, sore throat, lethargy, & h/a;
Numbness on entire left side of body including hands, legs, face. The vaccine was given on the left arm.
I believe the 2nd covid vaccination reactivated the shingles virus.  I had shingles in about 2009.  I have not been vaccinated for shingles but will once this bout has cleared up.
Pt. vaccinated w/Measles virus vaccine, live on 11-APR-90.  18-APR-90 or 19-APR-90 developed fever.  20-APR-90 developed rash pt was hospitalized on 24-APR-90 w/dx of measles w/dehydration & chest pain.  Rule out pericarditis.
Pharmacist administered Janssen Covid vaccine instead of second dose of Moderna  on 07/23/2021(friday) . It was a vaccination error .  I contacted patient on 07/24/2021 (saturday) , patient was fine. I also submitted error report to health department.
This spontaneous report as received from a certified medical assisted refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The medical assistant reported that those patients were administered with a dose of GARDASIL that had been improperly stored (doses, route of administration, indications, lot#, expiry dates unspecified) between 13-OCT-2013 and 13-NOV-2013. No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Received Pfizer COVID vaccine 12/26/2020 and 1/16/2021.   On 4/25/2021 developed loss of taste/smell, fever, and nasal congestion.  Tested positive for COVID.
A nurse reported that a child received an injection of Prevnar and subsequently, developed an injection site reaction characterized by an area of redness and swelling which was "about the size of a quarter". The pt recovered in less than 48 hours. No further information was available at the date of this report. The reporter indicated that 4 children experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. This is 1 of 2 reports from this facility of injection site reactions following receipt of Prevnar.
Soft tissue swelling and erythema at site of injection which tracked down into elbow. Not suggestive of cellulitis. Appeared to be non absorbed medium causing localized reaction.
After the vaccine I got tired, more joint pain, headaches, I'm short of breath, and I forget things. I went to my doctor and they put up doses of joint medication and gave me an anxiety medication, but it has made me feel badly and I stopped it.
A non-serious spontaneous report of FLUMIST administered to a 20-month-old was received from a registered nurse in the USA.  The reporter confirmed that there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  The case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Additional information was obtained on 21-Nov-2008 and incorporated into the narrative: patient demographics, FLUMIST administration date and route of administration, event outcome and other authorities informed.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "
after the first shot he had mild arm soreness; This is a spontaneous report from a contactable physician reporting for self. This male physician (patient) with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient reported that after the first shot he had mild arm soreness with no other symptoms. The outcome of event was unknown.   Information on the lot/batch number has been requested.
AFTER ADMINISTRATING VACCINES PATIENT FAINTED FACE FORWARD ON THE FLOOR LANDING ON HER FACE.. PATIENT WAS UNRESPONSIVE, PUPILS DILATED. EMS WAS CALLED . PATIENT STARTED HAVING TONIC SEIZURE THAT LASTED 30 TO 45 SECONDS, SHE THEN RECOVER CONSCIOUSNESS FOLLOW BY CRIES. PATIENT WAS TRANSPORTED TO THE ER VIA EMS FOR FURTHER EVALUATION DUE TO TRAUMA, SYNCOPY AND TONIC SEIZURE
COVID19 Positive after fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID19 Positive after fully vaccinated) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported.   This case was linked to MOD-2021-255524 (Patient Link).