chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse, concerning a female patient of an unknown age. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis (reported as "vaccine"). It was unknown whether she experienced side effects from this first dose. On an unspecified date, the patient was vaccinated with the second dose of GARDASIL 9 (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis (reported as "vaccine"). On an unspecified date, the patient experienced joint pain (arthralgia), so she was hospitalized for an unspecified time period and the reporter could not provide any details about treatment specifics during the hospital admission. At the time of the report, the outcome of the arthralgia was unknown. There was no product quality complaint (PQC) involved. The causality between the adverse event and GARDASIL 9 was unknown. Additional information is not expected, as the reporter did not wish further contact.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 11:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:09 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 19.47 on 28-Feb-2021 and 19.55 on 28-Mar-2021.  Concomitant products were not provided  On 28-Feb-2021, Excursion time was 9 AM and 1 PM, temperature were 27 and 26 respectively, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 28-Mar-2021, Excursion time was 10 AM, temperature was 35 respectively, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
The shot itself was very painful and the injection site was so painful, I had trouble using my left arm.  The muscle too sore.  Wed, the next day, my torso, front and back, broke out in small red extremely itchy bumps.  Seriously itchy.  I used topical creams: Caladryl, hydrocortizone, anti-itch creams, vinegar and baking soda.  I wrote a medical team member in my Patient Portal about the reaction I was having.  The itching continued for a total of 2 weeks, and I still had red bumps into the 3rd week.  One month after I got the shot, all bumps were gone.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    This case was for 29th patient out of 77 patients reported.  No concomitant medication information provided.  It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Vaccine was administered 3 days after vial expiration. Parent notified by provider. Provider has chosen not to revaccinate.  Parent agreed, child doing well.
Report a side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effect) 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
A few hours after receiving the Pneumovax23 vaccine, pt states she started feeling pain and numbness in the immunized arm. These sensations were to the point that she could not lift her arm or use that arm in any capacity. Two days after she received the vaccine, the patient reported being able to feel her hand and forearm again and having the ability to lift a glass of water. She still reported pain in the immunized arm and took Tylenol with codeine, which she had from an injury previous to this incident. Three days after receiving the vaccine, pt states that now she feels her arm is swollen, whereas she did not before. She states that she has regained a little more feeling up her arm, but still is in pain.
Information has been received from a physician concerning a 47 year old female with sinusitis, asthma and drug hypersensitivity to Ceftin who in approximately 2001 was vaccinated with a first dose of Pneumovax 23. The physician reported that her response "was not as expected." In July 2006, the patient was vaccinated with a second dose of Pneumovax 23. Subsequently, a recent titer showed response to 4 of the 12 Pneumovax 23 types tested. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. Additional information is not expected.
Dizziness, Headache, NauseaVomiting, insomnia, weakness
Pt recvd 3 doses of Engerix-B & did not convert; pt recvd booster dose of Engerix-B JAN92;
I was weak,had no energy; Listlessness; Fever of 103°F; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I was weak,had no energy), LISTLESS (listlessness) and PYREXIA (fever of 103°F) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced ASTHENIA (I was weak,had no energy), LISTLESS (listlessness) and PYREXIA (fever of 103°F). At the time of the report, ASTHENIA (I was weak,had no energy), LISTLESS (listlessness) and PYREXIA (fever of 103°F) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-265360 (Patient Link).
-16 weeks pregnant at time of booster shot or 3rd dose, weight 175, due date 4/14/2022 -no adverse reactions to first or second dose -Started mild itching on 11/10/2021 morning, by evening entire chest enflamed with hives, heat all over body. Hives moving from one spot to another. After 3 days of hives contacted primary doctor and OBGYN prescribed with Prednisone. OB said not pregnancy related rash and primary doctor unsure. Allergist appointment scheduled for December. Not food reactive after eating, constant motion and flare ups throughout morning and evenings on day 19 of hives 11/29/2021. Only change over last 6 months other than pregnancy is the COVID19 vaccine. -
13 month old female with a history of low grade fever to 100.7 associated with redness at injection site right anterior thigh.
Caused existing tinnitus in right ear much worse.  Noise is louder and hearing is reduced.  No dizziness.
24DEC conjunctivitis; 25DEC fever 105 & pt taken to ER w/tachycardia, poss lt ventricular hypertrophy; dx viral synd r/o bacteremia
Patient received COVID 19 Pfizer dose instead of receiving Flucelvax Quad dose. Patient was supposed to receive a Flucelvax Quad dose but received COVID 19 dose instead.
This spontaneous report was received from a healthcare worker and refers to two unspecified patients of unknown age and gender. No information about patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 29-JUL-2015, the patients were each vaccinated with one dose of improperly stored PROQUAD (Merck) lot# L005293, expiration date 17-AUG-2016 (strength, dose and route of administration were not reported). No adverse effect reported. Additional information has been requested.
Muscles pains, with spasms; Muscles pains, with spasms; Nausea; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit.; Too weak to perform normal activities/slept for 2 days straight; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient (pregnant: No) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: El1284 and Expiration Date unknown) via intramuscular route of administration on 05Jan2021 11:00 AM (Left arm) at single dose on arm for COVID-19 immunization. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: Eh9894) via intramuscular route of administration on 17Dec2020 05:00 PM (Left arm) at single dose for COVID-19 immunization. No other vaccine in four weeks. The patient's medical history included known allergy and None other medical history. The concomitant drug was reported as Birth control medication. On 06Jan2021 1:30 am the patient woke up with severe all over muscles pains, with spasms that Tylenol 1000mg did not resolve. The patient had nausea, lymphadenopathy on the left side of my arm, chest, neck with pain in my armpit. The patient slept for 2 days straight, too weak to perform normal activities. The patient continued to have some symptoms 3 days later. No treatment received for the adverse events of nausea, lymphadenopathy, pain in armpit, slept for 2 days straight, too weak to perform normal activities. No COVID prior vaccination and no COVID tested post vaccination. The outcome of event was recovering.
A few hours after receiving vaccine began to feel weak and mild fatique, then a cough started.the next day felt worse with a low grade fever; on second day was completely washed out with a fever - stayed in bed all day. On the third day, felt better and the fever subsided, took my pulse and it was 100 - normally 70. It's the rapid pulse that concerns me. TWill call the Doctor as soon as his office opens.
Inpatient consult has been requested on a 20 y/o patient hospitalized for severe thrombocytopenia and ITP in association with the receipt of vaccines.  Symptoms:  Petechiae, Lymphadenopathy, axillary.  7/14/09 Hospital records received DOS 4/27/09 to 7/8/09. Assessment: Thrombocytopenia NOS. Idiopathic thrombocytopenic purpura. Patient presented with mild left axilla pain and axillary lump. Bruise right politeal fossa, followed by mottling bruise / rash on feet, ankles, legs. MUltiple petechiae on lower legs, ecchymotic bruises on calves. Vaccination site - large purplish hued leasion with a darkish scar/old blood central area left deltoid. IVIG administration. Dyspepsia. Headache 'behind eyes', photophobia. 'Feeling terrible'. Not well hydrated, not active, uncomfortable, acutely ill.
Patients received wrong doses of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patients received wrong doses of the Moderna COVID 19 vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patients received wrong doses of the Moderna COVID 19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (Patients received wrong doses of the Moderna COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that five of the seven patients received a 3rd dose instead of the booster dose, while two of the patients received a double dose of the 3rd dose.  No treatment information was reported.
Mother was driving patient home after administration of vaccines and pt started to have swelling of her eyes and lips with hives and itching all over body. Mother brought patient back to the clinic, and pt brought back to room immediately and physician notified immediately. Physician assessed patient. Epinephrine 0.15mg (0.15mg/0.3mL) administered IM in pt's left thigh. Pt then given po Benadryl 7.5 ml (12.5mg/5ml) and Orapred 15.2 mL (15mg/5mL) in clinic. 911 called and pt transferred to Emergency Department. ED notified of pt's condition.
2 weeks post-vaccine significant onset of confusion, disorientation, hallucinations, cognitive decline. Hospitalized?> ?encephalopathy ? of unknown origin
I got the second booster at my pharmacy at 10:00am. That night around 1:00am I went into rapid afib. I was taken to hospital by ambulance. I was hospitalized for several day before my heart rate went into normal rhythm under medication. I had never had afib before.
Patient received Kinrix instead of Pediarix/Kinrix was the 3rd Dtap and IPV dose for patient; 12 month old patient received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included pediarix (1st dose received on 11th August 2022), pediarix (2nd dose received on 10th November 2022) and hepatitis B vaccine (received 3 hapatitis B vaccine on an unknown date).   On 19th May 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th May 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments: The health care professional (HCP) called to report a medical error, patient was supposed to receive Pediarix but received Kinrix.  On 19th May 2022, a 12 months female baby received a Kinrix vaccine.  This was the third Dtap dose on patient's schedule.  It was the patient's 3rd dose of IPV too.  The reporter consented to follow up. Additional Supportive Information: The patient was administered with kinrix instead of Pediarix, which led to Wrong vaccine administered and inappropriate age at vaccine administration.
Acquired hemophilia A; This literature-non-study case was reported in a literature article and describes the occurrence of ACQUIRED HAEMOPHILIA (Acquired hemophilia A) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.      No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACQUIRED HAEMOPHILIA (Acquired hemophilia A) (seriousness criterion medically significant). At the time of the report, ACQUIRED HAEMOPHILIA (Acquired hemophilia A) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered ACQUIRED HAEMOPHILIA (Acquired hemophilia A) to be related.    No concomitant medication and treatment medication were reported.  Company Comment: This is a literature non-study case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected, serious (medically significant) event of Acquired hemophilia A, immediately after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a literature non-study case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected, serious (medically significant) event of Acquired hemophilia A, immediately after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Cardiac change- new delta wave noted in EKG on 7/25/21.  No cardiac abnormalities prior to vaccine.
Breakthrough case after 3 vaccines Moderna 1/18/21 Lot# 010M20A;  Moderna 11/12/21 Lot# 034F21A;  pFizer 5/16/22 Lot# FP4554
She got her vaccine, she was just sore around the vaccination site and thought she had a little achiness.  She was then doing fine, had no other reactions and then on 4/26/23 she took a home test as she was having slight dry cough, headache, and then she was very very tired, and slept for about 3 days.  She took a home test and was positive for COVID.  It took her about 3-4 days to get over the symptoms, and then was OK, had some body aches for that 3-4 days and is still testing positive for COVID.   She did contact her doctor and was informed to drink lots of fluid and use OTC things for the body aches and headaches, get plenty or rest and use a vaporizer.   She is still having some congestion and sometimes she has a cough, but can breath through her nose, and never had a fever.  She is still a little bit tired, but pretty much back to normal.    She was with the V-safe system and felt that we needed to know that she tested positive after 5 vaccines.
ON 12/05/2022 I started experiencing a sore throat, bronchial spasms, coughing and extreme fatigue. I went to Urgent Care on 12/19/2022 I had a Chest x-ray, Strep test and COVID-19 all negative. They suspected that it was RSV and was prescribed an inhaler. My symptoms lasted for 12 days however I have had a lingering cough since mid Jan/2023.
Extreme full body eczema flare up that lasted about five months.  Treated with oral prednisone which unusually did not help subdue the inflammation.   Severe dyshidrosis on hands, feet, and legs which has been an ongoing condition
Patient received second dose on day 22, 7 days prior to when it should have been administered
Happened after 2nd set of vaccination on 5/19/06.  Within 24 hours of vaccines mom describes high pitch cry, questionable mental status changes, (maybe increased sleepiness only) last 72 hours.  Over last 2 years, story has changed to include possible decrease tone and lethargy.  I'm now having difficulty sorting out the story , the true events.  ? had fever after Hep B #1 at birth as well.