chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2022 at 12:52 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Mar-2022 at 12:52 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 19-MAR-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The patient received vaccine past its 30 days expiry date on 19-Mar-2022 at 12:52:43 PM. Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment information was provided.
Initial report received from physician on the 17/Oct/2005. A three and half year old male child developed redness and swelling at the injection site down to the elbow after receiving the injection of Fluzone, lot number U1753AA in the right deltoid on 9/19/05. the pt received in concomitant Havrix, lot number AHABV0711AA in the left deltoid. The pt was seen by a physician on 9/21/05 and was started on Zyrtec and corticosteroids. As per reporter the pt completely recovered within hours. Follow up information received on 12/21/2005 from a health care professional. the route of administration of the Fluzone was IM. To previous dose of flu vaccine were received prior to this vaccination. The adverse events of redness and swelling did extend to the elbow. The pts adverse events were treated with Prelone one teaspoon times two days, then one half teaspoon times two days, then on fourth teaspoon times two days, then stopped. No further information is expected.
The patient noticed her top lip was swollen the morning after the injection, then noticed swelling in top and bottom lip by the afternoon.  She took diphenhydramine.  The second day after the injection, she had some additional swelling and also noticed they felt tight and burning.  No breathing trouble was noticed.  She had taken additional doses of diphenhydramine.  She stopped by the pharmacy at this time and I suggested she talk to her PCP or go to urgent care.  Later that day she had a prescription of prednisone from urgent care.  She said the provider gave her some IV steroids which helped her.  The doctor did not think the vaccine was the likely cause of her symptoms, but it could not be ruled out.
This case was reported by a nurse via call center representative and described the occurrence of injection site tenderness in a adult patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number EF4Z9, expiry date 22nd June 2019) for prophylaxis. On 1st October 2018, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (subcutaneous) .5 ml. On 1st October 2018, unknown after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced intramuscular formulation administered by other route. On 2nd October 2018, the patient experienced injection site tenderness, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site tenderness, injection site swelling and injection site erythema were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site tenderness, injection site swelling and injection site erythema to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) stated that her co-worker was inadvertently administered FLULAVAL QUADRIVALENT 2018-2019 season subcutaneously instead of the indicated intramuscular route, which led to inappropriate route of vaccination. The HCP stated that the patient had redness, swelling, and tenderness at the injection site on the date of reporting, one day later. The HCP did not provide the patient information for this adverse event but did provide the lot number and expiry date for the adverse. This case is 1 of 15 cases, reported by the same reporter.
During 30 minute observation after 1st dose of covid vaccine patient began experiencing palpitations/dizziness with BP of 157/99, requested transfer to ED for further evaluation. Began experiencing scratchy sensation to throat, difficulty swallowing with hoarseness of voice 5 minutes after vaccination. Received epinephrine 0.5mg IM once, protonix 40mg IV once, and solu-medrol 125mg IVPB once in ED. Patient was observed in ER for 3 hours and reported having EpiPen and Benadryl at home, was discharged with Prednisone 20mg, 2 tablets daily for 3 days.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, 2 doses of improperly stored GARDASIL 9 lot# M005714 with expiration date: 03-MAR-2017 and 1 dose of improperly stored GARDASIL 9 lot# L020015 with expiration date: 16-AUG-2017 (dose and route of administration were not reported) were administered to the patients. Administered doses of GARDASIL 9 underwent temperature excursions at 49.5 Fahrenheit degrees for 1 hour. Data logger was not involved. Product quality complaint (PQC) was not involved. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
itchiness; numb on right hand pinky; 1st dose of Johnson&Johnson vaccine and booster dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), HYPOAESTHESIA (numb on right hand pinky) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Johnson&Johnson vaccine and booster dose of Moderna) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OL19E21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson&Johnson vaccine (Received 1st dose of Johnson&Johnson vaccine in April by a doctor at a diagnostic hospital. Had Severe itchiness and which went away.) in April 2021. Past adverse reactions to the above products included Itching with Johnson&Johnson vaccine. Concurrent medical conditions included Acid reflux (oesophageal) and Knee swelling (Does not take any medications because of her kidneys.).    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced PRURITUS (itchiness), HYPOAESTHESIA (numb on right hand pinky) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Johnson&Johnson vaccine and booster dose of Moderna). On 22-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of Johnson&Johnson vaccine and booster dose of Moderna) had resolved. At the time of the report, PRURITUS (itchiness) and HYPOAESTHESIA (numb on right hand pinky) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.  Company Comment : This is a spontaneous case concerning a 68-year-old female patient with relevant medical history of Pruritus after first dose of Johnson&Johnson COVID 19 vaccine, who experienced non serious, unexpected events of Pruritus and Hypoaesthesia. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Relevant medical history of Pruritus after first dose of Johnson&Johnson COVID 19 vaccine remains a confounder for the event Pruritus. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old female patient with relevant medical history of Pruritus after first dose of Johnson&Johnson COVID 19 vaccine, who experienced non serious, unexpected events of Pruritus and Hypoaesthesia. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Relevant medical history of Pruritus after first dose of Johnson&Johnson COVID 19 vaccine remains a confounder for the event Pruritus. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Vestibular neuritis starting on January 29 2021 and continuing through July 2021
Presented w/ SOB, nausea, decreased appetite, has been on supplemental O2 at home for several years. Covid +. Expired after cardiac arrest secondary to acute chronic hypoxic/hypercarbic respiratory failure d/t to Covid 19 pneumonia
difficulty breathing and stridor; difficulty breathing and stridor; noises on inspiration; dizziness; headache; sore throat; Anaphylaxis developed within 2 hours of injection; This is a spontaneous report from a contactable other health professional (patient).  A 57-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration in arm left on 08Jan2021 09:00 at single dose for covid-19 immunisation.  Medical history included Idiopathic Angioedema, Hypothyroidism. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient's concomitant medications were not reported.  Reported Event: Anaphylaxis developed within 2 hours of injection. 9:00 am injection;  9:05 am Developed sore throat, 9:20 am Developed dizziness and headache, 10:00 am developed noises on inspiration, 10:20 am Presented to Emergency Services, 10:40 am IV (intravenous) diphenhydramine (BENADRYL) and dexamethasone (DECADRON), 10:45 am difficulty breathing and stridor, 11:00 am intramuscular Epinephrine, 11:10 am Racemic Epi Nebulizer, 11:20 am Breathing improved, 14:00 Discharged home. The adverse events result in Emergency room/department or urgent care. The outcome of all the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis reactions considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition included Idiopathic Angioedema. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a "between 60 and 65 year old" male consumer who on unspecified date was vaccinated with one dose of Zostavax. There was no concomitant medication. The patient noticed red spots on his arm after vaccine administration, it was reported that the red spots were not at the injection site. Unspecified medical attention was sought. At the time of the report, the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
muscle pain is so strong that I can't have my foot firmly on the floor; muscle pain is so strong that I can't have my foot firmly on the floor; Fever; strong headache; muscle pain generalized; tiredness; This is a spontaneous report from a contactable other Health Professional. A 41-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. Medical history included fibromyalgia, Cardiac arrhythmia, allergy to crustaceans. The patient's concomitant medications were not reported. The patient previously took aspirin [acetylsalicylic acid] and experienced drug allergies, and the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular on 21Dec2020 09:30 AM at a single dose on left arm for COVID-19 immunization. The patient experienced fever, strong headache, muscle pain generalized, tiredness on 08Jan2021, and "muscle pain is so strong that I can't have my foot firmly on the floor" on 08Jan2021 07:00. No treatment was received for the events. The outcome of the events was not recovered. The events were assessed as non-serious. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information about Lot/Batch has been requested.
On 4/27, the pt's arm was really sore. It was still sore on 4/28. On 4/28, the pt also started to feel extremely tired, had 100.2?F fever, ear pressure, & chills. He took Tylenol & the fever, ear pressure, and chills subsided. On 4/28 near bedtime, he developed itchy hives on his right inner forearm (his 2nd Covid-19 Vaccine dose arm) and on the lower half of his back. He had corizone cream applied to the areas before going to bed. By the next day, 4/29, all symptoms resolved.
This case was considered medically important. Follow-up information provided outcome. Initial information regarding PREVNAR was received from a consumer then confirmed by the healthcare professional regarding a 2-month-old female patient who experienced partial seizures. At 3 months of age, the patient received the first dose on 02-Mar-2009. The patient also received a dose of ROTATEQ (Merck & Co Inc) on 02-Mar-2009. Concomitant therapy included H-B-Vax administered on 04-Feb-2009. Shortly after being administered the first dose of PREVNAR on 02-Mar-2009, the patient experienced partial seizures. The child was taken to the Emergency Room. Electrocardiogram, CT scan and blood test were done. results were unknown. The child was sent home. Since then, she has had 9 more seizures (03-Mar-2009, 04-Mar-2009, 07-Mar-2009 (2 seizures), 08-Mar-2009 and the last one on 10-Mar-2009), Electroencephalogram was done on 09-Mar-2009 which revealed an abnormality explained as the EEG showed that the child "would have had a seizure or seizures eventually". The patient recovered (2009). No additional information was available at the time of this report.
Edema and erythema at injection site 1 day after injection L thigh 10x9cm
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), on 29Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "sciatica" (unspecified if ongoing); "restless leg" (unspecified if ongoing); "BCC" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events VACCINATION FAILURE and COVID-19 and BNT162B2.
Beginning the evening of the same day when vaccine was administered, patient developed swelling in his armpit. The swollen lump measured about 4-5 inches in length and 2-3 inches in width, about 0.5-.75 inch raised from normal tissue. The swelling persisted for four days and then resolved.
Information has been received from office staff concerning an 8 year old female pt with "ADHD" and an allergy to "Dexadryn" who on 04/01/01 in the AM was vaccinated SC in the right arm with a first dose of varicella virus vaccine live.  There was no concomitant medication.  On 05/19/03, in the AM, the pt's throat was red but the throat culture was negative. On 05/19/03, in the PM (previously reported as 05/20/03), the pt developed a "varicella rash/chickenpox" with "nearly 100 lesions" on her face, arms, ears, trunk, hands, fingers, legs, back and buttocks, also described as mild "itching, multiple lesions" that were all papular and non vesicular. On 05/20/03, "next AM", vesicules with fluid were scabbed. A throat culture was "negative for strep" (previously reported as no relevant diagnostic lab data). It was noted that the physician recommended diphenhydramine HCL (Benadryl) every 6 hours. Calamine lotion was applied for itching.  It was also noted that this case was 22 months after the vaccine and was not a vaccine reaction. Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently, the pt recovered. No further information is expected.
slight soreness in the injection site; headache; fever -not confirmed but she had chills and shaking; muscle and joint aches; body aches; arm swelled; arm red; sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), SOMNOLENCE (sleepiness) and VACCINATION SITE PAIN (slight soreness in the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (breast cancer 6/7 years ago) and Renal surgery (cancer surgery last September (seems fine now)). Concomitant products included OMEPRAZOLE, LOSARTAN, EZETIMIBE, MONTELUKAST, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CALCIUM and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (body aches), PERIPHERAL SWELLING (arm swelled), ERYTHEMA (arm red), SOMNOLENCE (sleepiness), HEADACHE (headache), CHILLS (fever -not confirmed but she had chills and shaking) and ARTHRALGIA (muscle and joint aches). On an unknown date, the patient experienced VACCINATION SITE PAIN (slight soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, PAIN (body aches), HEADACHE (headache), CHILLS (fever -not confirmed but she had chills and shaking) and ARTHRALGIA (muscle and joint aches) had resolved. On 14-Mar-2021, PERIPHERAL SWELLING (arm swelled) and ERYTHEMA (arm red) had resolved. On 16-Mar-2021, SOMNOLENCE (sleepiness) had resolved. At the time of the report, VACCINATION SITE PAIN (slight soreness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
5/23/22 pt to ED with weakness, SOB; had been seen earlier by oncologist and pt found to be hypoxic; sent to ED; found to be positive for COVID; CXR showed bilateral COVID pneumonia; steroids, Remdesivir; worsening oxygenation; transferred to ICU; ABX; condition worsened over time; DNR; transitioned to comfort care; pt passed away in the hospital
pt recv vax & 10DEC98 c/o joint pain & numbness of right hand digits (more than the lt hand), wrists, & non-specific calf soreness;
developed a large swollen knot in the arm where she received the Flublok vaccine; Initial information received on 11-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves 30 years old female patient who developed a large swollen knot in the arm where she received the influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past vaccination(s) included influenza vaccine for Flu vaccination and covid-19 vaccine for COVID-19 immunisation. The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (lot number , strength, formulation, dosage, expiry date - not reported) via intramuscular route in unknown administration site for Flu prevention (Antiviral prophylaxis). Information on the batch number was requested  On an unknown date the patient developed a large swollen knot in the arm where she received the influenza quadrivalent recombinant vaccine (vaccination site swelling) (unknown latency).  Reportedly, : Patient have had reactions in the past to both flu and Covid vaccines- Patient developed a large swollen knot in the arm where they received the FLUBLOK vaccine- it resolved with no intervention   Patient did not experience any additional symptoms/events.  There were no lab data/results available  Action taken was not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Recovered / Resolved on 11-Oct-2022 for the event.