chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu-like symptoms; Fever chills; Drug dose administration interval too long; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), PARACETAMOL (TYLENOL 8 HOUR), APIXABAN (ELIQUIS), ALPRAZOLAM, EZETIMIBE, LISINOPRIL, ROSUVASTATIN and TACROLIMUS for an unknown indication.   On 06-Dec-2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In January 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On 31-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long). In 2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and PYREXIA (Fever chills) had resolved.            On unknown dates, the patient experienced flu-like symptoms and fever chills. In 2022, the patient experienced waited three weeks instead of two weeks to take humira due to received covid booster resolved. On unknown dates, flu-like symptoms and fever chills resolved.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 02-MAR-2015, a healthcare provider at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 18-OCT-2016, the patient was treated by a physician's assistant for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 1 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, during the vaccination with a one dose of M-M-R II (exact dose, route of administration, lot #, therapy type and expiration date were not reported) and one dose of VARIVAX (exact dose, route of administration, lot # and expiration date were not reported), the patient moved his arm at the time of administration of one of the vaccines, resulting in an unknown portion of the unknown vaccine being deposited on the skin. The patient received only a partial dose of the vaccine. The reporter stated that it was unclear whether the incident occurred with the M-M-R II or VARIVAX. Revaccination was not performed at the time of the report. No product quality compliant was involved. Follow Up information has been received from  the reporting registered nurse on 14-FEB-2017 and stated that on an unknown date, the child was receiving a routine dose of M-M-R II and just before the entire dose was administered the child moved their arm  and  the needle came out of the skin and a very small amount of the dose squirted into the air. There were no adverse vaccine reactions. The nurse explained that she requested recommendation regarding if a repeat dose was needed and within what time frame. Subsequently, the child had received the repeat dose of M-M-R II. Additional information is not expected because all follow ups requested to complete the case were received.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 21Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "M.S." (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Feb2023) Positive, notes: COVID 19 Treatment; (28Feb2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Feet swelling; 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 PERIPHERAL SWELLING (Feet swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Feet swelling). At the time of the report, PERIPHERAL SWELLING (Feet swelling) outcome was unknown.            No concomitant medication included.  No treatment medication included.   Reporter did not allow further contact
Even though taking Tylenol - had fever the next day that became increasingly higher. Highest Fever 101.5 first day after with bad chills all day,  achy joints,  dull headache and no energy.   Low grade fever 100.5 second day after with Dull headache and low energy.
Pt contacted facility with complaint of mild vertigo and chest heaviness approximately 2 hours after vaccination.
Pt requested injecion is glutes. Developed erythema, edema and noted knot in area, exam revelaed 3-4 cm area of muscle mass and hyperpigmentted skin at superior upper gluteus maximus.
Information has been received from a medical assistant concerning a 30 year old female patient with no known drug allergies and no pertinent medical history who on 21-FEB-2011 (it was also reported that therapy started on 21-APR-2011, dose reported as 0.5 mL), was vaccinated with the first dose of RECOMBIVAX HB (route and lot number not reported). On 21-MAR-2001, the patient was vaccinated with the second dose of RECOMBIVAX HB (route and lot number not reported). On 23-AUG-2001, the patient was vaccinated with the third dose of RECOMBIVAX HB (route and lot number not reported). There was no concomitant medication. On 20-MAY-2011, the patient came into the office and the physician did blood work. The test and results were "Hepatitis B surface antibody and result was nonreactive and a Hepatitis Fab and results was 5.48 mIU/mL". The medical assistant stated that on 09-JUN-2011, the patient was vaccinated with a fourth dose of RECOMBIVAX HB (route and lot number not reported). At the time of the report the patient had not recovered. Follow-up information received on 18-JUL-2011 from a Registered Nurse who stated that the physician had nothing further to add and did not want to provide more information. No further information is available.
- 7 days after vaccination, a rash (~2" diameter) with redness, itching, and swelling/lump formed around the injection site.  - By ~24 hrs after symptoms first appeared, rash had spread to ~3" diameter and itching/swelling was worse. Took some over-the-counter Benadryl before bed; symptoms reduced by the next morning (itching/swelling reduced, rash down to ~1" diameter).  - Currently 48 hours after symptoms appeared; mild symptoms remain, continuing to treat with Benadryl.
Extreme headache (like a hang over). It lasted for 3 days with the second day being the worst then subsided.
Immediately after the vaccine was administered on 02NOV2018, noticeable swelling and rigidity occurred at the injection site. The mother of the patient treated the affected area with warm compress and massage. According to the patient's mother, the induration seemingly became worse after the next two weeks. On 16NOV2018, the mother and the patient returned to the immunizations clinic. The affected area was still rigid and had turned purple from bruising. The patient was referred to their PCM and advised to continue home treatment.
14 minutes Hypertension 200/120 Tachycardia 140 Facial and chest flushing Extreme dry mouth, chills
post-herpetic neuralgia in his upper body, particularly the shoulders; skin lesions developed on his head and forehead; Information has been received from a lawyer referring to a male patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. In or around January 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) being administered, the patient developed skin lesions developed on his head and forehead, and this resulted in post-herpetic neuralgia in his upper body, particularly the shoulders, that also persists to the present. The patient first learned of the link between zoster vaccine live (ZOSTAVAX) and injuries such those from which he (conflict information, also reported as she) suffered, on or about February 2019. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of the zoster vaccine live (ZOSTAVAX) that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the patient. The outcome of the events skin lesions developed on his head and forehead  and post-herpetic neuralgia in his upper body, particularly the shoulders was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events skin lesions developed on his head and forehead  and post-herpetic neuralgia in his upper body, particularly the shoulders to be disability.
Information has been received from a medical assistant concerning a 16 year old female who was vaccinated with a dose of Gardasil. A few days after vaccination, the patient experienced headache, dizziness and passed out. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), on 07Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 07Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Severe adverse side effects from fillers on" (unspecified if ongoing), notes: Severe side effects from fillers on face after Pfizer CoVID Vaccine. Ongoing treatment; "swelling" (unspecified if ongoing), notes: more than 12+ near and around the filler injection sites all over my face; "hard lumps" (unspecified if ongoing), notes: hard lumps more than 12+ near and around the filler injection sites all over my face. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine"; Codeine, reaction(s): "nausea"; Vicodin, reaction(s): "known allergies: Vicodin"; Vicodin, reaction(s): "nausea". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of drug ineffective, suspected 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: Linked Report(s) : US-PFIZER INC-202300298514 same patient and reported; different vaccine dose number and event;
Reported Symptoms:  10002391:ANGINAL PAIN; Narrative:  Pt reported unstable angina eventually requiring PCI approximately 3 months after 3rd dose of Pfizer Covid vaccine Other Relevant HX: No tobacco use
A report has been received from a Health Professional concerning an adult, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 01-Nov-2014. It was reported that, the Nurse informed medirep while on a office visit the afternoon, that she administered FLUMIST to her husband in november 2013 and some of the medication went into his eye which started on 01-Nov-2013. The patient recovered from the event of THAT SHE ADMINISTERED FLUMIST TO HER HUSBAND IN NOVEMBER 2013 AND SOME OF THE MEDICATION WENT INTO HIS EYE on an unspecified date. The report was considered to be non-serious.
On drive home anaphylactic reaction (trouble swallowing, swollen tongue), went to Emergency Room, treated with benadryl. Returned to ER a week later with new symptoms, severe headache, nausea, tightness in chest, trouble breathing .
UPON SUBMITTING THE VACCINE (AFTER ADMINISTRATION) IT WAS DISCOVERED THE PATIENT WAS UNDERAGE TO RECEIVE IT.
Some vials were used and returned to the freezer; experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F) 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)) 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)) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer), PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Some vials were used and returned to the freezer) and PRODUCT TEMPERATURE EXCURSION ISSUE (experienced excursion, from 13SEP2022 until end of NOV2022. Max 11.2 F & Min 20.3 F).    No concomitant medication reported.  Storage condition at the time of the excursion was frozen storage. Vial size was reported as both 2.5 mL or 5.5 mL. Bivalent batch numbers were AS7146B MFG Exp. Date: 27-MAY-2023, Lot# 019H22A MFG Exp. Date: 30-MAY-2023. Temperature was on & off out of range from 13-SEP-2022 until end of NOV-2022. Max: 11.2 F & Min: 20.3 F. Excursion duration was 1 month.  It was unknown when vial moved from freezer to refrigerator. Returned to the freezer and some vials were used. At the time of excursion there was no inspections done.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-686130 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-686130:
Pt became fussy and remained so for the afternoon. Pt cried inconsolably for one hour. Pt taken to urgent care and exam was normal.
significant pain at the injection site and pain upon any movement, chills, aches at joints and gums, extreme fatigue, migraine headache, nausea, diarrhea, stomach pain, headache, loss of appetite
Pt vaccinated at 10 am on 7/13/15 with DTaP #3 and Hep B #3. Parents returned to clinic at 3:10 pm with patient complaining of swelling of lips, hands and genitals. Pt's temp was 98.6 axillary. Parents advised to monitor swelling and temp and go to ED if any increase in symptoms.
fever; nausea; chills; headache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     Concomitant products included INSULIN for Diabetes mellitus, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication has been reported.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: 15 minutes after immunization, patient reported that she had tingling on the arm and in the fingers after injection. Pt said the tingling got better. I let pt know that it could be temporary due to nerve irratation, which should go away in a couple of days; however, it could also be nerve damage that may last longer and have a more severe impact. Pt will watch out closely for a few days and contact doctor if it gets worse or does not go away after 2-3 days. I will follow up 11/11 and/or 11/12.
5cm raised red urticarial rash w/central clearing; 3cm in diameter around inject site (HIB vax);
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 04-Nov-2021, the vial was initially stored in the refrigerator. The Vial did not go undergo any temperature excursion. The patient had no any adverse event post administration of expired vaccine. Treatment information was not provided.