chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had ZOSTAVAX shot on Tuesday Feb. 16, 2010. Next day, Wednesday, had swollen arm size of tennis ball at injection site. On Thursday larger part of upper arm swollen and by Friday was swollen down to elbow. Called MD office, Triage Nurse said use BENADRYL and she did and she came in here and we told her to also use Ibuprofen. Called pt today, doing much better, swelling down.
flushed; face turned really red within a few minutes after receiving the vaccine; terrible trembling; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 Vaccine, Lot number was not reported), via an unspecified route of administration on 21Feb2021 as 1st dose, single dose for covid-19 immunisation. Medical history included autoimmune disorder from an unknown date and unknown if ongoing, cutaneous lupus erythematosus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The caller stated that she became very flushed and her face turned really red within a few minutes after receiving the vaccine (21Feb2021). She also states that later that evening (21Feb2021) she started to have "terrible trembling" and then the symptoms got better. The patient stated, "I don't think it had anything to do with the vaccine itself, I think it was because I have lupus and anything that I put into my body causes me to have a reaction." She had spoken with her HCP and they told her that she may not build any antibodies since she has an autoimmune disorder. Caller clarified that she was not on any immune suppressants for her condition. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Administration after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV  (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's comment: The reporter stated that there were multiple excursions over 21 days that it went below 34.7 Faraday temperature and was administered.  HCP(Health Care Professional) did not have patient's details, lot number or expiration dates.  No additional information provided. The reporter consented to follow-up. Additional Supportive Information: The administration of FluLaval Quadrivalent, Pediarix and Kinrix after being exposed to freezing temperature, which led to Incorrect storage of drug.
This case was reported by a healthcare professional and described the occurrence of injection site pain in a 55 year old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. Concurrent medications included Ramelteon (Rozerem). The Subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 09, November 2006 the subject received unspecified dose of Fluarix in the left deltoid. On 09, November 2006, less than one day after vaccination with Fluarix, the subject experienced injection site pain. The subject described the pain as "constant and five out of ten for the 1st three days, then 3 out of 10 since that time." At the time of initial reporting, 05, December 2006, the event was improved. Follow-up received on 28, December 2006 indicated that the subject's relevant medical history included chronic interstitial cystitis and chronic prostatitis. The subject has taken other influenza vaccines without problems. the reporter considered that the events were possibly related to the use of Fluarix.
fever reaching 104 F; chills; headache; severe body aches; joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Apr2021 23:45 (Lot Number: ew0162) as SINGLE DOSE (at the age of 34 years old) for covid-19 immunisation.  Medical history included chronic kidney disease from an unknown date and unknown if ongoing , bipolar disorder from an unknown date and unknown if ongoing , migraines from an unknown date and unknown if ongoing.Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported.  The patient previously took augmentin [amoxicillin sodium;clavulanate potassium] and experienced Known allergies: augmentin, vancomycin and experienced Known allergies: vancomycin, lamictal and experienced Known allergies: lamictal,  Historical vaccine information included BNT162B2 Pfizer, Lot number er8730, Administration date 28Mar2021 03:00 am in the Left arm, Dose number: 1 for covid-19 immunisation at 34 years old.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  On 19Apr2021 12:00 pm, the patient experienced fever reaching 104 F, chills, headache, severe body aches and joint pain. No treatment was received for the events. Outcome of events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
FIRST DEVELOPED A FINE RASH LIKE HIVES PER PATIENT AND THEN 1 WEEK LATER DEVELOPED CHILLS AND A FEVER 1/28/2011 AND SWELLING OF HIS TESTICLES WITH SORENESS ALSO STATES SOME SWELLING OF LYMPH NODES IN HIS NECK AREA
Swelling started on left upper thigh on 5-11-10. Decreased swelling 5-26-10. Today 5-27-10 still knot on thigh. Child in no distress.
Patient called with L deltoid swollen x 8 day.  Area red swollen, itching, hot to touch.  Dr prescribed Benadryl and Keflex.  Followed up with patient is doing fine now.
EN route to the hospital his COVID-19 PCR returned positive. He has received his first dose of remdesivir and dexamethasone per protocol.  Follow-up chest x-ray this morning was reassuring.  He is requiring 2 L nasal cannula. Transplant Infectious Disease has been consulted.  On-call critical care consultant is also aware of the situation.
1.  Palpitations with PACs and PVCs documented by 30 day Rhythm monitoring.   I am experiencing worsening symptoms.  2.  Profound sleep disturbances +  extreme dreaming
Administration Error: A 16-year-old female patient receives her booster dose of the Moderna vaccine, an action which does not comply with the established CDC booster dose guidelines.
Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022; Patient received Moderna vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 076C21A, 026L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Clonidine Hcl), Drug allergy (Diltiazem Hcl), Drug allergy (Tramadol), Drug allergy (Nitrofuran Derivatives), Sulfonamide allergy (Sulfa) and Allergy to antibiotic (Cephalosporins).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks/ stored in fridge on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The caller was a health care professional who stated that they administered the Moderna COVID-19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The caller explained that since the expiration date was not written on the vial they had not noticed it had already expired. Date the vial was initially stored in the refrigerator: 17-May-2022. The vial did not undergo any temperature excursions. Number of doses/vials: 26 doses. Treatment information was not provided.
Arm got a big red knot on it, heat coming off & had a fever, they think it got into lymph nodes. over a week per patient
Pt experienced drooling, fever, left hand tingling, neck swelling and rash at injection site
1 day p/vax pt exp "localized rxn". Pt upper left arm swollen 5 to 6 days. Fever for 24 hr. Pt also exp achiness,dizziness, nausea & h/a.
I feel like I'm getting pricked around my heart; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (I feel like I'm getting pricked around my heart) and HYPERSENSITIVITY (Allergic reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (I feel like I'm getting pricked around my heart) and HYPERSENSITIVITY (Allergic reaction). At the time of the report, CHEST DISCOMFORT (I feel like I'm getting pricked around my heart) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided.  No treatment medications are provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Added Event as Allergic reaction.
No additional AE; patient received first dose of VAQTA at age 6 months, and second dose at age 6 years.; patient received first dose of VAQTA at age 6 months, and second dose at age 6 years.; This spontaneous report as received from a medical assistant refers to a 6 month old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   On an unspecified date in July 2003, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated(VAQTA) (strength, dose, route, lot number, and expiration date were not reported) for prophylaxis. It was reported that the patient received the second dose of hepatitis a vaccine, inactivated(VAQTA) (strength, dose, route, lot number, and expiration date were not reported) for prophylaxis in approximately 2009 (reported as "at age 6 years"). No additional adverse events were reported.
Shingles diagnosis after second shot.  Back of right leg.  Took medication.  Shingles gone for 3 weeks Shingles came back same area of leg on 10/2.  Got prescription immediately
Fever of 103 degrees rectally night of immunizations and the next morning. Goes down w/TYLENOL.
Had influenza vaccine late afternoon 2/15/08. Had some leg pain that night. Woke up the next morning with leg pain and redness at immunization site. Redness progressed - was seen in ER and admitted to hospital for thigh cellulitis. Received IV antibiotics.  9/16/08 Reviewed hospital medical records for 2/17-2/18/2008. FINAL DX: cellulitis Records reveal patient experienced sleeplessness, crying, lethargic, decreased energy, diet refusal, swelling & redness left thigh, Fever & limping.  No reaction to prior immunizations.  Tx w/IV antibiotics & had allergic reaction to Vancomycin.  Improved & d/c to home w/pcp follow up next day.
This spontaneous report was received from a nurse refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # M003659, 20-SEP-2017, lot # L017407, 15-AUG-2017. No adverse effects reported. the vaccines reached 15.5 c for 3hours. Data logger was yes. Additional information has been requested.
This spontaneous report as received from a consumer refers to a 5 years old male patient. The patient was vaccinated with ROTATEQ (lot #, dose and route not reported). No other co-suspects and no concomitant medications were reported. The consumer reported that since an unknown date while on ROTATEQ the patient (her son) did not eat eggs any longer. The patient also had unspecified bowel issues. The patient visited the doctor and no treatment was given for the reported events. The outcome of the events was reported as not recovered. The relatedness for the reported events was not provided for ROTATEQ. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & shortly p/devel SOB, shakiness, vertigo & a feeling of throat closing; pt was seen in ER & treated w/DPH;
Soreness in arm, extreme chills, headache, body aches, dizziness and fatigue for 3 days. This is day 4 and most symptoms have passed except for dizziness and fatigue. It was like covid all over again. Hope shot number 2 is less severe.
A 10-year-old asthma patient who was fairly well controlled, has been receiving Nucala since May 2021 without adverse effects and has received the influenza vaccine in past years with no issues (per parent report), received Nucala 40mg SQ and influenza vaccine during an outpatient clinic visit on 10/5/2021. On 10/7/2021 this patient experienced a life-threatening event and died. Death does not appear to be connected to Nucala and Fluarix received on 10/5 Patient has a history of environmental and food/nut allergies.  There may be a correlation between allergies and the reaction.
Dime sized area of induration appeared immediately after injection. Ice applied to area off and on during the day.  Induration had lessened and was size of a quarter 6 hours later.  No redness or itching.  Area mildly tender to touch.
Cellulitis developed with red, hot and firm areas at and adjacent to injection site. Started on antibiotic, antihistamine, anti-inflammatory and ice packs. Upper left arm 3" X 6" into axilla.
INITIALLY WARM FEELING ON THE LEFT ARM, INJECTED ARM, WHICH RADIATED TO FACE AND DOWN LEFT SIDE.  24 MAR 2010 FLU LIKE SYMPTOMS:  RHINITIS, HEADACHE, SORE
Pt given vax 31AUG90 & 25OCT90; On 29OCT90 pt exp feb sz hospitalized & t107, rt tympanic memb red, urine cult-E. Coli, CSF cult-lymphocytes 10 & RBC 224; Later 2nd sz, t101.1, irritable, red, bulging lt tymp memb, OM, poss pyelonephritis
7 days p/vax pt devel fever 105;fever broke 2DEC95 & rash erupted;mom described the rash as being raised red bumps that started on stomach & eventually spread to head;4DEC95 mom reports rash starting to go away;clinic contacted during fever
Mother reports child became febrile at about 5 pm on 7/30/14. Forehead scan temp 101 degrees F/Rectal 99 degrees F/axillary not reported. Child appeared lethargic "not crawling much" Nasal congestion noted. Continues to breastfeed WNL. Mother reports pediatrician made aware with Childrens TYLENOL tx continuing.
This case was reported by a pharmacist via call center representative and described the occurrence of tingling in a 75-year-old female patient who received SHINGRIX (batch number M77B4, expiry date 8th February 2021) for prophylaxis. On 4th August 2018, the patient received the 1st dose of SHINGRIX. On 8th August 2018, 4 days after receiving SHINGRIX, the patient experienced tingling and generalized pruritus. On an unknown date, the outcome of the tingling and generalized pruritus were unknown.  The reporter considered the tingling and generalized pruritus to be possibly related to SHINGRIX.  Additional details were provided as follows: The patient experienced tingling and itching over the entire body. At this point it was unknown whether these reactions were subsided. No additional information was provided.
Patient had first dose of Phizer Covid vaccine on 4/20/21 by home health at home. Patient reports over the past 2 days has a productive cough of green mucous. Scattered blisters on RLE and a more condensed area of small blisters under abdominal skin fold near pubis/peri area. Peri area ia painful when cleaned. Patient is afebrile. Breath sounds decreased BLL, otherwise clear. Patient continues to be bedbound since fracture acetabulum on 3/2/2.
Cramping in intestines. Loose stool 6:30 til 3 am on 3/19/21,  7:30 am on 3/21/21 cramping still at 11:30 while completing this form. Lack of appetite.
I received my first Moderna vaccination on 2/2/2021 at 3:10PM. About 3 days afterwards, I felt extremely fatigued and had headaches and body aches. About 3 weeks later, I then developed severe pain in the right knee. It was so intense I could barely move or walk. I went to the doctor, who gave me anti-inflammatory medication and recommended that I also take Tylenol; the medication helped. I also underwent a CAT scan, and it showed that everything was normal aside from some arthritis. The pain gradually improved until it finally went away about a week later; because of the pain, I was unable to work for a week. I wore a knee brace, which also helped, and went to a physical therapist 3 times.
Fever, chills, body ache, head ache and general fatigue and drowsiness.
Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from a nurses. This case is linked with case 2018SA206713 for same patient. This case involves a 17 years old female patient who was exposed to vaccine ADACEL while pregnant, patient was seven weeks pregnant. The date of last menstrual period was reported as 26-May-2018. The estimated due date is 02-Mar-2019. The patient's past medical history and family history were not provided. No concomitant vaccines given. On 24-Jun-2018, the patient received a 0.5ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, lot U5852AA, expiry date 16 Jan 2020 via unknown route in the left deltoid. It was an actual medication error due to vaccine exposure during pregnancy. It was reported that received ADACEL following a foot injury and the patient was seven weeks pregnant at time vaccine given. Lab data was not provided. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Did not feel well after second dose; Feeling sick; Fever; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not feel well after second dose), MALAISE (Feeling sick), PYREXIA (Fever) and FATIGUE (Exhausted) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION COMPLICATION (Did not feel well after second dose), MALAISE (Feeling sick), PYREXIA (Fever) and FATIGUE (Exhausted). At the time of the report, VACCINATION COMPLICATION (Did not feel well after second dose), MALAISE (Feeling sick), PYREXIA (Fever) and FATIGUE (Exhausted) outcome was unknown.            No concomitant medication was provided by reporter.  No treatment information was provided by reporter.   This case was linked to MOD-2021-378344 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Non-Significant Follow up-Document attached
Mild soreness at site of injection; A spontaneous report was received from a Moderna employee from social media concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild soreness at site of injection.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unreported date in 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unreported date in 2020, the patient experienced mild soreness at the infection site. No treatment information was provided.   Action taken with the drug in response to the event was not reported.  The outcome of the event, mild soreness at site of injection, was not reported.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# not provided), who experienced an expected event of mild soreness at site of injection. The patient details, Lot# for the vaccine and time to onset for the events of mild soreness at site of injection was unknown. The reporter did not provide the causality assessment for the events.