chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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. 023H22Ab) 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) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse 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 aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    Vaccine administered after after 4 temperature excursions  No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 31th of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:Master case
pt recv vax 11MAR96 & called on 19MAR96 w/ c/o inj site red,swollen w/center hard to touch,instructed to come by clinic 20MAR96 to assess inj area-2 1/2" x 2 1/2" area red w/center approx 3/4",hard to touch-referred to PMD;
Pt got shot at 12:37 pm and asked to wait 15 mins Around 12:42pm he went to bathroom  and came back at 12:53pm, sat in waiting chair and begin to lose consciousness. Pharmacy tech associate noticed he was slumping over, breathing and making loud growling /  humming sound. Pharmacist came over , shake him for responsiveness. Management called Emergency responders. His eyes open and closed a bit. After one minute he came to.  We called code white, management, EMT and fire rescue came and took over. Escorted to hospital after that.
Severe immune deficiency, wild type and vaccine strain, developed signs of disseminated skin rash, severe varicella, currently taking Intera-Acyclovir.
Child immunized on 8/19 PM. Fever at 103.7 by 2300 on 8/19. Given infant Tylenol with results repeatedly over the course of 4 days. Able to get temp to 99 degrees on 8/20 x 1 hours. Developed raised red rash on 8/21 covering body. Inconsolable crying 8/19 - 8/23. Refusing to eat. Difficulty breathing: "wheezing". No further information is available. Mail that is sent returns. Moved with no forwarding address.
red and was moving to the back of the arm; itching; more swollen; hurt and at night it hurt more and couldn't lie on that side; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 20-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red and was moving to the back of the arm), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (hurt and at night it hurt more and couldn't lie on that side) and VACCINATION SITE SWELLING (more swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced VACCINATION SITE PAIN (hurt and at night it hurt more and couldn't lie on that side). On an unknown date, the patient experienced ERYTHEMA (red and was moving to the back of the arm), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE SWELLING (more swollen). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 500 mg. At the time of the report, ERYTHEMA (red and was moving to the back of the arm), VACCINATION SITE PRURITUS (itching), VACCINATION SITE PAIN (hurt and at night it hurt more and couldn't lie on that side) and VACCINATION SITE SWELLING (more swollen) outcome was unknown.            Action taken with mRNA-1273 in response to the events was  not applicable. Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up information received on 20-May-2021 and included no new information
Mild Guillain-Barre syndrome in arms and hands, resolved with no additional treatment within 8 hours
I was driving on the highway and experienced numbness starting in my lips.  This numbness then moved throughout my body into my limbs.  I had some mobility and was able to pull off of the highway down an exit but at one point, I could not lift my legs or control my hands.  I called 911 but it was very difficult to do so with the numbness.  I then started to regain my mobility but had some continued numbness around the left side of my mouth.  The paramedics tested my vitals and everything came back as normal.    They recommended that I have someone come pick me up. So I had a neighbor come pick me up and someone drive my car home.  I did not lose any vision or mental capacity throughout this.  It was just a wave of numbness throughout my entire body.  It lasted 5-10 minutes but felt like an eternity. I am lucky to be alive and to not have crashed my vehicle into someone or something.
raised rash in center of lower back, similar to poison ivy, but without blisters. Also, area around injection site is raised and itchy, but not painful
TOOK SECOND DOSE A DAY LATE; This spontaneous case report (PVX2019-2417) was received from a pharmacist on 23-Sep-2019. It described a female consumer who "took second dose a day late" (PT: Inappropriate schedule of product administration), while on Vivotif for an unknown indication.  Case report: The consumer took the second dose of Vivotif a day late. The doses were taken on 18-Sep-2019 and 21-Sep-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.
missed the window for getting the second dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the window for getting the second dose of the Moderna vaccine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (not related to the Moderna vaccine).    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the window for getting the second dose of the Moderna vaccine). On 04-May-2021, PRODUCT DOSE OMISSION ISSUE (missed the window for getting the second dose of the Moderna vaccine) had resolved.        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.   The pharmacist confirms the patient did not experience any adverse events after the first dose. The pharmacist did not know if the patient is on any daily medication. The pharmacist explained the patient received the first dose and then went for a routine surgery (not related to the Moderna vaccine) and was in the hospital longer than predicted and missed the window forgetting the second dose of the Moderna vaccine. no concomitant and treatment medications reported.
Swelling, redness of leg immediate area approx. 2x2 also with faint red splotches all down leg. Increased in coughing noticed day of shot and next. Treated with Benadryl and cool compresses.
Erythematous swelling of arm (resolved) at site of vaccination (pruritic).
Fever up to 102.8, large area left arm firm painful and warm, Bell's Palsy, body aches, terrible headache X 3 days
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-APR-2016, the patient was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event was not reported. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Severe Headache that will not go away; Joint pain; Dizziness; Swollen lymph node; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Apr2021 at 10:00 (at the age of 17-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included trazodone (MANUFACTURER UNKNOWN) and lithium (MANUFACTURER UNKNOWN) both for unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient experienced severe headache that did not go away, joint pain, dizziness and swollen lymph node. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events. The clinical outcome of the events severe headache that did not go away, joint pain, dizziness and swollen lymph node was not resolved, at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Throat felt Constricted; Throat felt / inflamed; developed hives / "hives on the inside."; This case was reported by a consumer via call center representative and described the occurrence of throat constriction in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies.   On 13th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than 2 weeks after receiving Shingrix, the patient experienced throat constriction, pharyngeal inflammation and hives. The patient was treated with methylprednisolone sodium succinate (Solumedrol) and ambiguous medication nos (Epipen (Nos)). In September 2020, the outcome of the throat constriction, pharyngeal inflammation and hives were recovered/resolved.   It was unknown if the reporter considered the throat constriction, pharyngeal inflammation and hives to be related to Shingrix.  Additional details were reported as follows: The patient reported that after having Shingrix vaccine in left arm, she developed hives and her throat felt constricted and inflamed. She described the sensation as hives on the inside. She was given 2 shots of solumedrol and an Epipen. The symptoms were resolved. The reporter did not consent to follow-up.
some arm soreness; slight headache; exhausted/ slept lot for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 10:40 (Lot number: EN6201) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Runny nose", start date: 16Mar2020, stop date: 2020, notes: 16Mar- runny nose (lasted for weeks); "No smell", start date: 19Mar2020, stop date: 2020, notes: 19Mar- no smell/no taste (lasted a month); "no taste", start date: 19Mar2020, stop date: 2020; "Cough", start date: 20Mar2020, stop date: 2020; "Tightness across shoulders", start date: 25Mar2020, stop date: 2020; "Exhausted", start date: 25Mar2020, stop date: 2020, notes: 25Mar- tightness across shoulders, exhausted, (lasted several more weeks. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Vaccination Date: 30Jan2021, Time: 3, Location: Arm left, Lot number: EL3248), administration date: 30Jan2021, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 18Feb2021, outcome "recovered", described as "slight headache"; FATIGUE (non-serious) with onset 18Feb2021, outcome "recovered", described as "exhausted/ slept lot for 2 days"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "some arm soreness". Therapeutic measures were not taken as a result of headache, fatigue, pain in extremity.  Additional Information: No, other product were taken together with those indicated above. Patient did not require visit to Emergency Room. No, AE(s) require a visit to Physician Office. On 24Mar2021 Patient Contacted doctor but had to fill in form only, no testing for covid available except if fever and hospitalized. Patient was unable to talk with her primary care doctor, so finally got now It was reported that patient was using Antipyretic. Ibuprofen 200 mg, Dose/Route of administration, 2(200) mg tablets, patient took ibuprofen several hours after first dose of vaccine and again, several hours after second dose of vaccine.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with doses of GARDASIL (dose, route, lot numbers and expiration dates were not provided), that were improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Fever. Pt seen less than 1 hr ago, per mom pt's eyes rolled to the back of his head, for about 4 min in the car.
FATIGUE; Skin pain; trembling; CHILLS/Teeth chattering; SKIN SENSITIVITY; NAUSEA; HEADACHE; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 9 hrs after receiving Shingrix, the patient experienced chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain. On an unknown date, the outcome of the chills, sensitive skin, nausea, headache, tremor and skin pain were recovered/resolved and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain to be related to Shingrix.   Additional details were provided as follows: Before 6 months from the date of reporting the patient received 1st dose of Shingrix. 9 hour after receiving the vaccine the patient experienced the patient described the skin sensitivity as pain on her skin all over the skin was sensitive to the touch, the chills were described as trembling and teeth chattering. The fatigue was better but still present at the time of this report.  The events were lasted approximately 8 hours.  For tolerance to 2nd dose refer linked case US2020AMR093114, reported by the same reporter. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR093114:dose #1
Pt got vaccine on 10/25 began to have symtoms that evening. Redness and soreness got worse went to urgent care on 10/27 at noon and was give MOTRIN 800 and cephalxin 500. Being treated for cellulitis.
Redness to chest & itchy all over. Pt has history of hives with codeine, tylenol. BP 120/79; HR94; RR 20. Pruritis resolved 20 minutes after Benadryl given
Around March 20, 2022 patient had a cough develop and it continued to get worse. On March 25, oxygen was only 85% and was given 2 nebulizer treatments that brought it up to 89%. He was take to ER and they admitted him to the hospital for heart failure and pneumonia. He had a BMP of over 1000. He had bibasilar filtrate in lungs. They did an x-ray and CT scan. He was treated with Lasik and Doxycycline. Patient was in hospital for 3 days and then released to a rehab hospital for one day. He currently in under home health care. A week after getting out of the hospital the patient experience a-fib and was given 2 new medications which has helped. He is still dealing with the heart failure but is getting better.
Fever on day 9 and full body rash starting on head and moving gradually moving down body on day 12
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX. Concomitant products included Levothyroxine. On 30th April 2018, the patient received SHINGRIX. On 30th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, fever, headache and myalgia. On an unknown date, the outcome of the injection site pain, fever, headache and myalgia were unchanged. The reporter considered the injection site pain, fever, headache and myalgia to be almost certainly related to SHINGRIX. Additional details were reported as follows: This case was previously not reported to anyone. The age at vaccination was not reported. The patient experienced soreness at the injection site. The patient also experienced fever (body temperature: 100.1 degree F).
PATIENT CALLED ON-DUTY PHARMACIST AT STORE TODAY TO REPORT HER ARM WAS ONLY NOW IMPROVING AFTER RECEIVING HER SECOND BOOSTER(4TH TOTAL) SHOT OF COVID-19 PFIZER FROM MAY 16/2022. SHE REPORTS HER ARM NEAR AND AROUND SITE WAS BLACK/BLUE, PAINFUL, SORE, AND NOT ROUTINELY RECOVERING AS WITH ANY OF THE PREVIOUSLY GIVEN VACCINES IN THIS OR ANY OTHER SERIES EVER. SHE REPORTS SHE DID NOT SEEK MEDICAL ATTENTION AT ALL UPON INITIAL ONSET, BUT CALLED TODAY TO REPORT DISSATISFACTION.  SHE REPORTS SHE IS "only now recovering", so I am recording as such in item 20.
Woke Up to use restroom after sleeping a bit. Fainted (full loss of consciousness) while seated on toilet, and ultimately landed on my head on the bathroom floor.
hypertension; This is a spontaneous report from a non-contactable other healthcare professional. An adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 31Mar2021 (Lot Number: en5318) as single dose for COVID-19 immunisation.  The patient had no relevant medical history. It was unknown if the patient was pregnant. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 31Mar2021 at 17:00 the patient experienced hypertension. The patient respirations were normal at 18, pulse normal in the range of 80s, trending blood pressure started at 152/100 and went up to 176 within 20 min. The adverse event resulted in emergency room visit. No treatment was received for the hypertension. The clinical outcome of the hypertension was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Hypertension cannot be excluded.  The case will be reassessed if additional information becomes available.  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.
Approximately 5 minutes after the injection my heart rate went up into the 160s.  I believe at it's highest it was 161. This lasted about a minute or so and then it came back down.  The nurse monitored me for 30 minutes and my heart rate maintained a normal rythem and no other symptoms arose so I was released.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.