chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse and refers to a 14 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 18-JAN-2017. On 07-FEB-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M038860 with expiration date of 13-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 21 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
The patient was administered an improperly stored dose; No adverse event; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.      On 30-AUG-2019, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S004548 with expiration date of 12-AUG-2020 (indication, strength, frequency, dose, route, and anatomical location were not provided) for prophylaxis. No adverse event reported. The vaccine was exposed to a temperature of 47.3 °F during a time frame of 20 minutes and called by a data logger.  This is one of multiple cases from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2005USA000302: US-009507513-2005USA000310: US-009507513-2005USA000317: US-009507513-2005USA000352: US-009507513-2005USA000356: US-009507513-2005USA000357: US-009507513-2005USA000359: US-009507513-2005USA000389: US-009507513-2005USA000401: US-009507513-2005USA000413: US-009507513-2005USA000431: US-009507513-2005USA000465: US-009507513-2005USA000488: US-009507513-2005USA000493: US-009507513-2005USA000495: US-009507513-2005USA000498: US-009507513-2005USA000505: US-009507513-2005USA000510: US-009507513-2005USA000512: US-009507513-2005USA000614: US-009507513-2005USA000624: US-009507513-2005USA000735:
Sore arm after 2nd dose; Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after 2nd dose) and PYREXIA (Fever after 2nd dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after 2nd dose) and PYREXIA (Fever after 2nd dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after 2nd dose) and PYREXIA (Fever after 2nd dose) outcome was unknown. Not applicable      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant details were provided No treatment details were provided     This case was linked to MOD-2021-020171.
Rash started 2/5 and became more diffuse thru night and AM 2/6; intense erythematous macules without confluency on face, trunk, arms, legs, palms and soles; no oral lesions noted; (+) itching; afebrile; mild UAC; (-) conjunctivitis.
Received shot at 4:00 PM, 2 AM that night symptoms started: fever, chills, nausea, vomiting, headache, body aches. Took Tylenol and all symptoms were gone in 48 hours
Arm soreness/under pain in arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had arm soreness. The reporter consented to follow up. The reporter wanted to know was this normal. This case linked with US2020AMR082455, reported by same reporter.
Swelling of face; Eyes swollen; Pollen allergy; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of face), (Eyes swollen), (Pollen allergy) and (Flu-like symptoms) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product(RINVOQ) for Rheumatoid arthritis.       On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2021, the patient experienced (Flu-like symptoms). On an unknown date, the patient experienced (Swelling of face), (Eyes swollen) and (Pollen allergy). At the time of the report, (Swelling of face) and (Eyes swollen) had not resolved, (Pollen allergy) outcome was unknown and (Flu-like symptoms) had resolved.            The patient had swelling in his face and eyes. Patient said it could be due to allergies from the pollen in the air. Patient was also sick for 2 weeks with flu-like symptoms after having the Moderna Covid booster and flu like symptoms was the only adverse event reported. Although patient never had a fever. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment medications were not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.
No adverse reaction. Patient was administered the wrong vaccine. Needed Pfizer Bivalent booster 12yrs+ but was given Pfizer Bivalent booster 5-11 yrs.
Information has been received from a nurse practitioner concerning an 87 year old female patient with hypertension, hyperlipidaemia and hypothyroidism, no drug reactions/allergies, who in approximately December 2007, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID and ACTONEL. On 7-DEC-2008 the patient had a rash which was red and vesicular. It did not cross the midline. Rather, it went down her right flank area, sown her back and down her right posterior leg. The patient had associated numbness and tingling. the patient was prescribed VALTREX. The patient sought medical attention. AT the time of reporting, the patient had not recovered. This is one of several cases from the same source. Additional information has been requested.
Reporter states pt did not seroconvert p/receiving Engerix series; all injections were administered IM;
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A, 038B21A and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Sulfa), Drug allergy (Erythromycin) and Allergy (Serious allergy to food, a vaccine component or latex).   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-424036 (Patient Link).
She got her vaccine, within 10-15 minutes she was talking to her sister and she put her hands out and she had not read any reactions.  She stretched out her arms in front of her and noticed that the middle fingers on the left hand was twitching. Then a little bit later there was a muscular contraction in the middle of her left thigh, midway between her hip and knee on the anterior side.  Was an intermittent muscular contraction on the same side she got the shot.  The twitching back and forth of her finger was 1/4 of he way.  She googled it and saw that it may be related to the vaccine.  Friday, it continued twitching back and forth like a metronome.  If she stretches her forearms out prone the ring finger, middle finger and especially the middle finger.  Saturday the symptoms were still there but not as much.   The thigh symptoms continued for about 2 hours.  She walked from her sisters house which is about 1/2 block and it disappeared.  The finger issues are more long-term and some numbness in the hand itself.  Her right hand at times this weekend had jiggling fingers, but the left is the worse.  It is intermittent movement and slight 1/8" movement on those 3 fingers still.  There is a general numbness in the fingers as well, not 100% like it's supposed to feel  This is going through the entire left arm and down into the hand.  It is not as constant that it was on Friday, getting better and just intermittent right now.  She has not contacted her doctor yet, but states that she will.   She noticed a clumsiness and a sense of unsteadiness with her walking and felt safe doing so.    She may have gotten COVD in Feb/March 2020, said she had almost every symptom from COVID and had lost her sense of smell, slight diarrhea, sore throat, runny dose, temp of 100.3.  She still has some loss of sense of taste.    She was told at one time that she had markers for Sjogren's.
Child into clinic for reactions to immunizations on 8/14/03. Immunizations given on 8/12/03. Mom noted on 8/13/03 swelling to right thigh where IPV and DTaP was given. Mom states right thigh swollen; decrease in swelling and redness on 8/14/03. Doctor noted right thigh swollen knee to hip; not red or tender at time of visit.
Feels like a prolonged asthma attack; shortness of breath; Coughing; Flu like symptoms; Fatigue; Muscle pain, aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Feels like a prolonged asthma attack), DYSPNOEA (shortness of breath), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms) and FATIGUE (Fatigue) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced ASTHMA (Feels like a prolonged asthma attack), DYSPNOEA (shortness of breath), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (Muscle pain, aches) and PYREXIA (Fever). The patient was treated with BECLOMETASONE DIPROPIONATE (QVAR) at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, ASTHMA (Feels like a prolonged asthma attack), DYSPNOEA (shortness of breath), COUGH (Coughing), INFLUENZA LIKE ILLNESS (Flu like symptoms), FATIGUE (Fatigue), MYALGIA (Muscle pain, aches) and PYREXIA (Fever) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported.  It was reported that after stopping treatment drug the event reoccurred and not resolved.
no adverse event; HCP called in to report a temperature excursion on VARIVAX and PROQUAD. HCP reports that 9 patients were administered VARIVAX. HCP reports that the VARIVAX administrations occurred on 6/21/22, 6/23/22, 6/27/22, and 6/28/22. The patients involved in t; This spontaneous report was received from the medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in June 2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin) subcutaneous injection, lot #U030591, expiration date: 29-MAR-2023, for prophylaxis (dose, strength, route of administration and anatomical location were not provided). The vaccine was administered after the temperature excursion (product storage error). No additional adverse event reported.; Sender's Comments:  US-009507513-2206USA008805: US-009507513-2206USA008806: US-009507513-2206USA008807: US-009507513-2206USA008808: US-009507513-2206USA008809: US-009507513-2206USA008810: US-009507513-2206USA008811: US-009507513-2206USA008804: US-009507513-2206USA008802: US-009507513-2206USA008801: US-009507513-2206USA008800: US-009507513-2206USA008799: US-009507513-2206USA008803:
The first day I had runny nose and runny eyes. The next day I was achy and had a temperature. I just felt really crappy. The hospital said I had a bit of a sinus infection. I ended up going to the ER twice.
Patient has a history of seizures. Patient was feeling fine, then found herself on the floor. She hit the top of her head with a small amount of blood (on blood thinners). No tongue biting, no urinary incontinence.
PATIENT RECEIVED TWO SHOTS, FLUZONE HD AND PNEUMOVAX23 IN HIS RIGHT ARM. THE ARM WAS RED AND SLIGHTLY SWOLLEN. IT WAS WARM TO TOUCH. THERE WAS NO REMARKABLE HARDNESS IN THE INJECTION AREA. ADVISED PATIENT TO TAKE TYLENOL AND USE ICE TO BRING SWELLING DOWN.
Sept.9 pt. received smallpox vaccine, urine Hcg negative at that time patients LMP: 8/14/03. On 9/22/03 patient's urine Hcg postive
Patient was given Moderna-2nd Dose Booster on 4/26/2022. Vial expired on 4/24/22.  Moderna and CDC-Agency notified.  Advised to re-vaccinate.
Urticarial rash covering the trunk, thighs, and arms beginning about 48 hours after injection worsened with time. Some resolution with benedryl.
Day of injection: Immediate injection site swelling, redness, pain and burning.  5/20/2020 - currently: Fatigue, hot sweats, fever, body aches, chills, joint pain (fingers), ringing in ears and headaches.  Menstrual cycle has also stopped.
Patient presented with ascending weakness and numbness, significant decline in ability to walk over 5 days, clinically improved but incompletely after 4d course of IVIG starting 12/30/21
Information regarding Flumist was received from a healthcare professional regarding a 30 year old female pt who experienced muscle aches, nasal burning, nasal tingling, nasal congestion and nasal bleeding. At 30 years of age, the pt received the first dose on 10/28/03. The pt experienced muscle aches, nasal burning, nasal tingling, nasal congestion and nasal bleeding on 10/28/03. At the date of the report, muscle aches and nasal bleeding has resolved; however, nasal burning, nasal tingling and nasal congestion had not resolved. The pt was being treated with Sudafed and Nasonex. No additional info was available at the time of this report.
Coldness in hands and feet; a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head; Headache; Nausea; Coughing; prevented her to drink or eat; experienced fever like symptoms; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL COLDNESS (Coldness in hands and feet), FEELING HOT (a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head), HEADACHE (Headache), NAUSEA (Nausea) and COUGH (Coughing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Asthma (Occasional requires an inhaler).    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL COLDNESS (Coldness in hands and feet), FEELING HOT (a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head), HEADACHE (Headache), NAUSEA (Nausea), COUGH (Coughing), FEEDING DISORDER (prevented her to drink or eat) and PYREXIA (experienced fever like symptoms). At the time of the report, PERIPHERAL COLDNESS (Coldness in hands and feet), FEELING HOT (a hot sensation but her temperature was normal at 98.6F/Hot sensation in the head), HEADACHE (Headache), NAUSEA (Nausea), COUGH (Coughing), FEEDING DISORDER (prevented her to drink or eat) and PYREXIA (experienced fever like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.6f normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include inhaler for asthma.  No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Non-significant follow-up
- stye on left eye - uncontrollable diarrhea - diagnosed with lymphocytic colitis - shortness of breath - blood in urine - hematuria
Information has been received from a healthcare worker concerning a 16 year old female with no known allergies who on 14-Aug-2007 was vaccinated with the first dose of Gardasil.  On 25-Oct-2007, she was vaccinated intramuscularly in the right deltoid muscle with the second dose of Gardasil.  On 25-Oct-2007, the patient experienced painful injection site which had gotten progressively more painful, starting after vaccination with Gardasil.  The patient had difficulty moving the arm because it was "very painful".  The pain in the arm was in an area 2 inches around the injection site and the area was not red or swollen.  The patient's painful injection site persisted.  The patient sought medical attention by calling the physician's office.  Additional information has been requested.
full dose then administered on second attempt; Vials had missing component that keeps vials secure; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2021-2022 season) (batch number A2AK3, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2021-2022 season (intramuscular) and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not report Health care professional reported Flulaval administered as a partial dose after the needle separated from the syringe, which led to accidental underdose. Health care professional reported full dose then administered on second attempt. Health care professional was unable to provide adverse event. The reporter was asked at what step was the defect discovered and when putting needle on and heared the click. The reporter was asked whether or not the product was administered or partially administered included statement to provide this information even if did not seem applicable and received a reply as 1 patient. The reporter was asked if health care professional preparing/administering vaccine was a new or experienced user, so got answer as experienced user. The reporter enquired to clearly describe which component was impacted and got answer as vials had missing component that keeps vials secure. The reporter was asked what type of needle was used and if any defect or damage on the syringe was noticed and got answer as no. The reporter was asked while removing the cap, was it pulled off or screwed off (as it should be), the health care professional was unsure. The reporter was asked about the needle connected and was it screwed on the device or pushed on, the health care professional was unsure. The reporter was asked if a problem was detected when screwing the needle on, did the customer continued to attempt to screw it on (perhaps stripping the locking mechanism), the health care professional stopped when they heard a click. The reporter was asked if the device began to spin around the syringe cone, did you hold the device in place when attaching the needle, the health care professional was unsure.
Headache from 2hrs post injection. the following week developed nasal congestion, sore throat, cough, runny nose. no fever.
Injection site following vaccination with PEDIARIX swollen and red 2/17/16 with abscess formation requiring I and D. Culture results no growth. 5/3/16 Probable seroma at injection site with PEDIARIX. Both developed about 1 month after vaccines administered.
I have had chills that does not seem to go away without a fever. Just random chills like goosebumps; I have had chills that does not seem to go away without a fever. Just random chills like goosebumps; Just random chills like goosebumps. After my first vaccine i got a weird cold sensation throughout my left arm and it happened again last night; This is a spontaneous report from a contactable consumer, the patient. A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL1284), dose 1 via an unspecified route of administration, administered in arm left on 18Jan2021 17:00 as dose 1, single and dose 2 via an unspecified route of administration, administered in arm left on 05Feb2021 (lot Number: EL3249) as dose 2, single (at the age of 22-years-old) for covid-19 immunization. Medical history reported as none. The patient concomitant medications were not reported. The patient had chills that did not seem to go away without a fever. Just random chills like goosebumps. After her first vaccine she got a weird cold sensation throughout her left arm and it happened again last night. The patient did not receive any treatment for events. The patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient visited the doctor or other healthcare professional office/clinic for the events. The patient did not have COVID prior the vaccination and did not test post vaccination. There were no allergies. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.