chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose administered to the patient after exposure to room temperature for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to the patient after exposure to room temperature for more than 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022 at 4:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Apr-2022 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to the patient after exposure to room temperature for more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to the patient after exposure to room temperature for more than 24 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  A vial was taken out of the freezer on 23-Apr-2022 and was punctured at 24-Apr-2022, 11 A.M. The vial was left out in room temperature until a dose was given from the vial to the patient at 25-Apr-2022 4 P.M. The pharmacist would urgently like to know if the dose was appropriate that was administered.  The vial was initially stored in the refrigerator on 23-Apr-2022.  The vial did not undergo any temperature excursions.  The total amount of time for which the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) was 29 hours.  No treatment information was reported.   Reporter did not allow further contact
2.5 cm Induration, 6x4.5 cm erythema and treated with antibiotics.
This case was reported by a nurse and described the occurrence of injection site pain in a 31-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline).  On 13 April 2009, in the morning, the subject received 1st dose of BOOSTRIX (0.5 ml, route unknown, right arm).  On 13 April 2009, almost immediately after vaccination with BOOSTRIX, the subject experienced injection site pain, stiffness in neck and down left arm.  The events were "much improved" two days later.  At the time of reporting the events were improved.  Follow-up received from the reporting healthcare professional on 13 May 2009:  BOOSTRIX was administered intramuscularly.  The events resolved on 24 April 2009.
Suspected vaccination failure/Had Shingrix, has a case of Shingles; shingles; This case was reported by a physician via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a case of shingles (which confirm) at the time of reporting. The patient wanted to know if he should have Shingrix again since it had been over 4 years. The patient asked if there was any current guidance on whether a repeat series should be necessary in an immunocompetent patient and in his case, when would it be safe to gave another series if he wanted one and if it were not contraindicated. No further details were provided on web form. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule and laboratory test confirmation were unknown at the time of reporting. The reporter consented to follow-up.
Pain, inflammation, swelling, weight loss, rashes, fatigue, insomnia, weakness, depression since onset have seen several specialists (from 9/25/05 to present) (multiple treatments).  10/2/07 Reviewed hospital medical records which reveal patient experienced diffuse body myalgias, arthralgias, pain in left subcostal area,intermittent diarrhea, night sweats, anorexia & weight loss of 52 # since 9/2005.  Admitted 2/3/06-2/9/06.  Had exposure to bat w/?rabies 9/2005 & received IVIG.  GI, ENT, cardiology, pain management & psych consults done.  Remain stable in hospital & d/c to home. FINAL DX: nonspecific myalgias & myositis; depression; mild restrictive lung disease; gastric ulcer disease; intermittent diarrhea; gastritis; esophagitis.
Bells Palsy on right side of  face, loss of taste on right side of tongue, inability to move right side of mouth, paralysis of right side of face from forehead to chin. Inability to close eyes, move lips raise brow, tinnitus right ear.
She got her vaccine, while she was in the car coming home she started with a headache in the back of her head, and also felt spacy, night right.  Had this with the first one but that was minor.  By the time she got home (1 1/2 hours), her stomach felt funny and had vicious diarrhea immediately and started throwing up.   She still cannot hold down anything.  She does take Zofran on a regular basis to hold down liquids.  She has not been able to eat food since the vaccine.   She went to the ER after being sick for 5 days, and she was admitted as her potassium was under 2 and she had to go the cardiac unit as she was susceptible for a heart attack and a stroke.  They gave her 4 bags of potassium and her potassium level actually went down due to the vomiting and diarrhea, and then took potassium pills and drink to get it up to 3 so that she could leave the hospital, which she did on 5/20/21.   She was okay during this time and very exhausted and still not able to eat.  Was discharged home with Compazine and Zofran.  On June 31st she started throwing up again and has no energy and still cannot eat and having the diarrhea again.  She is forcing fluids after taking the Zofran and then throws up again.  She has not called her PCP to inform them that she is still throwing up.
FEVER 103, VOMITING x 5 DAYS PERSISTENT PAIN IN ALL JOINTS x SEVERAL MONTHS AND STILL PERSISTING SEVERE WEAKNESS x 3 DAYS
This spontaneous report was received from a pharmacist technician referring to an 84 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-FEB-2017, the patient received an expired dose of ZOSTAVAX subcutaneously, lot # K019388, expiration date 20-JAN-2016 for prophylaxis. No adverse effects were reported. No further details were provided. Additional information has been requested.
woke up 4-15-21 with sore R arm from elbow down. 4-16-21 Had pain fRom deltoid to tingling in her fingerz She   had pain to R axillaRy region to upper lateral breast.  stated " It Feels just like Mastitis".   Rx: Bactrim DS BID x 7days
Swelling erythema warmth around site of injection extending 4cm. 3 days later with T 100 and erythema extending distally about 6cm.
Within hours, patient had soreness in the shoulder where the flu immunization was administered.  The pain continued to get worse.  Two weeks later she went to the doctor.  He stated she had an infection in the bursa and the pain was related to the immunization being administered in the bursa.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.Patient took other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19,drug ineffective started on Jul2022 and stop date Jul2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a medical assistant, referring to an unspecified patient of unknown age and gender that on an unknown date was vaccinated with an incorrect stored dose of PROQUAD lot # M048201 expiration date 05-JUN-2018, for prophylaxis; which experienced a temperature excursion to -13.4 Centigrade degrees for 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
I was fine for 12 hours after the vaccine just tired and sore arm. I fell asleep early and woke up at midnight covered in sweat with severe all over body bone pain. It hurts to walk or move around. My arm has a lump from injection and it is very sore.
Pt was given a varivax immunization on 2/9/22 slotted for adult vaccinations. CDC has been contacted and their instruction was the following: there is no indication that a dose of this vaccine even one slotted to an adult age group will have any adverse effect on the patient, CDC informed us that the Pt does not need a re-dose, or follow up care beyond these reports. Pt has not reported any adverse effect.
Information has been received from a physician concerning a male patient who "quite some time ago", was vaccinated with a dose of PNEUMOVAX 23 (route and lot number not reported). On an unknown date "quite some time ago", the patient experienced cellulites like reaction around the injection site after receiving the PNEUMOVAX 23, "it got really red and swelled up". The physician reported that the patient had deceased and stated that it was unrelated to the PNEUMOVAX 23 vaccine. It was unknown if the patient sought medical attention. Outcome of cellulites like reaction around the injection site was unknown. Additional information has been requested.
persistent rashes; This spontaneous report was received from a lawyer regarding a case in litigation and referred to an adult patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route, lot number and expiration date were not provided). On an unspecified date (reported as subsequently), the patient experienced persistent rashes. On unspecified dates, the patient was treated by healthcare providers for the event. The outcome of the event was not reported. The lawyer considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt woke up with CP and SOB in the early morning hours on 1/22/09 and got tachycardic and SOB trying to climb stairs later that day. Went to health services for evaluation and was sent to local ER and diagnosed with myopericarditis. Was hospitalized overnight and sent home on ENDOCIN. Symptoms: Chest Pain, Dyspnea (shortness of breath).   5/18/09 ED and hospital records received DOS 1/22/09 to 1/23/09 FINAL DIAGNOSIS: Myopericarditis, elevated troponin and chest pain, normal coronary arteries, normal left ventricular systolic function. Post vaccination: intermittant chest discomfort, dull ache, pain worse with deep breathing and lying flat.  5/26/09 medical records received DOS 1/22/09 to 2/3/09. FINAL DIAGNOSIS: Acute Myocarditis Post vaccination presented with chest pain, shortness of breath, tachycardia.
12days after the vaccine,  I developed a large injection site reaction; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration administered in left arm on 17May2021 at 15:30 (at 16 years old) as single dose for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. Medical history included hyper igd Iga nephropathy from unspecified date. The patient had known allergies (Known allergies: Yes). Concomitant medications included magnesium, colecalciferol (VITAMIN D), iron, and multivitamin; all from unspecified date. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient reported 12 days after the vaccine, the patient developed a large injection site reaction, which was non-serious on 29May2021 at 07:00. Treatment for adverse event included diphenhydramine (BENADRYL). Outcome of the event was recovering.    Information on the lot/batch, further information has been requested.
Information has been received from a Certified Medical Assistant concerning a pateint who was vaccinated with a dose of Pneumovax 23 and on 11-MAY-2007 was seen in the office with large red blotches on the arm that the injection was administered in. The patient was started on unspecified antibiotics. The patient's outcome was unknown. Additional information has been requested. The reporter indicated that another developed red blotches after receiving a dose of Pneumovax 23.
Information has been received from a physician via a company representative referring to a 74 year old female patient. The patient's history condition included she was a stem cell patient. The patient's concomitant medication and drug reactions/allergies were not reported. On 26-FEB-2019, the patient was vaccinated with GARDASIL 9 (route, dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis. Physician reported the patient did not experience any adverse effects from receiving dose of GARDASIL 9.
booster; blood sugar rise; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization, reaction(s): "blood sugar rise"; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization, reaction(s): "Blood suger rise". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar rise". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101742491 same patient, vaccine, AE and different dose;US-PFIZER INC-202101741528 same vaccine, AE and different patient;US-PFIZER INC-202101744010 same vaccine, AE and different patient;US-PFIZER INC-202101744009 same vaccine, AE and different patient;US-PFIZER INC-202101742765 same vaccine, AE and different patient
A moment after getting the HPV vaccine the patient slumped over toward MA as she was placing syringe down. When she and mom who had come over raised him up he appeared conscious and was laid down on table.   He was observed in the office. He was alert with clinician went in to examine a few minutes later and per medical assistant may not have lost consciousness unless only momentarily. He felt dizzy.  He had not had fluids or breakfast.  Orthostatic Vitals: Lying  HR 45 127/67, Mean 87; Standing HR57 124/66, mean 85; Sitting HR48, 118/55, Mean 76
3 to 4 days after had extreme dizziness, where the room spun completely.; Had mild flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Had mild flu like symptoms) and DIZZINESS (3 to 4 days after had extreme dizziness, where the room spun completely.) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Glaucoma. Concomitant products included LOSARTAN for Hypertension.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Had mild flu like symptoms). On 25-Jan-2021, the patient experienced DIZZINESS (3 to 4 days after had extreme dizziness, where the room spun completely.). On 23-Jan-2021, INFLUENZA LIKE ILLNESS (Had mild flu like symptoms) had resolved. On 25-Jan-2021, DIZZINESS (3 to 4 days after had extreme dizziness, where the room spun completely.) had resolved. Not Provided      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.   Other concomitant medication included eye drops for Glaucoma. No treatment was received by the patient.   This case was linked to MOD-2021-116597 (Patient Link).
I developed a red inflamed area about 2.5 inches in diameter at the injection site and it was itchy. I seems to be getting better and this is the 6th day after the itching and redness started.
Severe vomiting  lasting  10.5 hours, Fever 101.7, headache, chills, hot sweats. All all lasting between 12am-10:30am.  After the vomiting subsided I was able to take Tylenol for the fever and all symptoms resolved.
Swelling in throat, red eyes & difficulty breathing. Went to ER then admitted to hosp stat.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Additional Details: patient's mother told that pt has sickle cell's disease. As rph wasn't unsure the disease's effect on covid 19 vacicne. Rph asked pt to stay in resting area for 30 minutes. Approximately, 25 minutes after the patient got the shot, her mother reported her having allergic reactions. Patient reported as having dizziness, not being able to hear, nausea, and some eye blurness. I gave water, candy, and benadryl. Also 911 called just in case. By the time emergency team arrived, pt was doing fine back
About 9 days after first vaccine, began experiencing loud Tinnitus./ took second vaccine still have Tinnitus and it has not gotten better; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 11Mar2021 at 08:30 (at the age of 61-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies to food, medications or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unspecified indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021, about 9 days after first vaccine, the patient began experiencing loud tinnitus. She took her second vaccine at the same location and still had tinnitus and it had not gotten better. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event loud tinnitus and still had tinnitus and not gotten better was not recovered.   No follow-up attempts are needed. No further information is expected.
METALLIC TASTE; SLIGHT HEADACHE; This spontaneous report received from a parent via a company representative concerned a 3 decade 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 not reported, batch number: Unknown) 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 metallic taste, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste, and slight headache. This report was non-serious. This case, from the same reporter is linked to 20211017006.
A few minutes after my second dose vaccine I developed a rash. I received steroids and topical cream and also take Cetirizine medication. I did not think much of it because the time frame date correlates with spring time. As far of today but I still have the rash and it has not gone away. My Doctor told me that she does not believe it is correlated to the vaccine, but it was an allergic contact to the vaccine. I changed all my detergents but my allergy still persists. I can also say that all my symptoms occurred after receiving my second dose vaccine. I have three years in this location and I will be having a new appointment with my PCP soon and I am still constantly taking antihistamine medication today.
Severe rash started from the area near the vaccinated site then spread all over the body. The child is still suffering from severe and daily life interesting rash all over the body from head to toe as of today (2/5/2015).
Swelling, itching, slight redness, warm to touch and induration. Redness and induration 2 inches in diameter. Induration has decreased in firmness from what it felt like this AM, according to nurse who examined him in AM. Waited until today to ice arm. Refused to use any antihistamine or IVP for pain. Was given ice pack at 4 PM to take home with him, 1/10/12. Suggested again, taking oral medication for allergic reaction and to buy Benadryl cream to rub into left deltoid. It would cost them money.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/23/21 2nd dose01/13/21 Diagnosed covid positive:08/21/21 Symptom onset:09/19/21 Exposure: Symptoms:fever, cough, muscle aches,diarrhea,fatigue, chills,runny nose,HA
No additional adverse events; a patient was administered an improperly stored VARIVAX that was reconstituted with properly stored DILUENT.; a patient was administered an improperly stored VARIVAX that was reconstituted with properly stored DILUENT.; This spontaneous report was received from a medical assistant referring to a 3 week old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concurrent condition were not reported.    On 02-DEC-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (dose, strength and route were not provided; lot# S020464, expiration date reported as 21-JUL-2021, but internal generated as 02-JUL-2021; lot# S021928, expiration date 15-JUL-2021) for prophylaxis (product storage error and product administered to patient of inappropriate age). The vaccine was reconstituted with properly stored diluent. The temperature/time frame included 15 degree fahrenheit to 46 degree fahrenheit (35.7 F) for 2 hours. There was no previous temperature excursion. No data logger was involved. No additional adverse events were reported.