chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has a rash on the left fore arm (same side of her body as the flu shot we gave yesterday). She said her doctors office told her to get benadryl and hydrocortisone cream to be used until she can be seen. She has an appointment with MD for further guidance. Looked like possible poisen ivy to me but she denied any contact with plants. She's following up with MD to see what she should be doing. Rash was about the size of a deck of cards. We sold her the benadryl and hydrocortisone and referred her to follow up with her doctor.
ON 11/5/17 IN THE EVENING PT NOTICED THAT SHE STARTED FEELING PAIN AND WARMNESS TO TOUCH AT THE SITE OF INJECTION AND AREA IS RED. SHE TOOK TYLENOL TO HELP WITH THE PAIN AND INFLAMMATION.
I was 35 weeks pregnant with my first child with a low risk pregnancy and had no prior signs of preterm labor. I went to pharmacy and had TDAP vaccine injection on 7/25/2017 and then on 7/ 27/ 2017 my membranes ruptured and I had a preterm birth at 5lbs 5oz. My baby was in the NICU for 48 hours and I was home with him within a few days.
Ten minutes after receiving the vaccine,  she developed a pruritic urticarial rash.  She took Benadry 25mg by mouth and symptions resolved.  When she awakened the next morning the rash and itching had recurred and she had swelling of the eyelids and a sensation of trouble breathing.  On exam she had a widespread urticarial rash.  Her throat was normal and her lungs were clear.  Her O2 saturation was 98% and vital signs were normal.  After a PO dose of Benadryl 25mg,  her symptoms resolved within 10 minutes.  She was observed for about an hour, then discharged with a Prednisone 10 mg,  6 day taper(60,50,40,30,20,10)  At a follow-up call several hours later she was feeling fine.
Patient called pharmacy a few hours after receiving vaccine and reported she needed to call an ambulance due to shakiness, temperature increase and blood pressure increase.  I don't think I know the full story, but she did not need to visit a doctor.  I don't think any medications were administered and she reported to be fine after the ambulance left.  I followed up with her husband 1 day later and he said she has been fine ever since.  She did state to me several times that she is very sensitive to medications and thought the high dose flu shot is too high of a dose for her (at time of administration, she did request high dose flu shot).
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-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 04-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2022 at 12:38 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Mar-2022 at 12:38 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-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 04-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 04-MAR-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 04-MAR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient allergies to medications, food and other products was unknown.  No concomitant information was reported. Vaccination date was reported as 04 Mar 2022 12:38:52.The patient received booster dose. Its 30 days Expiry date vaccine went into 2 to 8 °C thaw state on or about to 20-Dec-2021, this vaccine administered until its Mfg date of 04-Apr-2022.  No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
A consumer report has been received concerning a foetus of unknown gender. No information regarding relevant history, concurrent disease and concomitant medications was provided. The consumer reported that he and his wife had received nasal FLUMIST from their doctor on 24-Oct-2013 and his wife was pregnant for seven months. The foetus was exposed to vaccine via mother and at the time of reporting experienced no adverse event. Consumer asked if there was any risk to his wife and the foetus. The outcome of the event of no adverse event was unknown. The company physician assessed the event of no adverse event to be serious due to the criterion of important medical event.
pruritic area of irregular wheal 10 x 20mm w/ 100mm x 100mm erythema, no other s/sx.
Fever, cellulitis at and around injection site, swelling, redness, warmth of area around injection site.
depressed; tired all day; slight temperature; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DEPRESSED MOOD (depressed), FATIGUE (tired all day) and PYREXIA (slight temperature) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 20-Mar-2021, the patient experienced FATIGUE (tired all day) and PYREXIA (slight temperature). On 21-Mar-2021, the patient experienced DEPRESSED MOOD (depressed). On 21-Mar-2021, FATIGUE (tired all day) and PYREXIA (slight temperature) had resolved. On 23-Mar-2021, DEPRESSED MOOD (depressed) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Patient was treated with Fluids. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
feel freezing; temperature which read 104 degrees Fahrenheit; feel cold; she felt hot inside; A spontaneous report was received from a consumer, concerning  a 69 years adult female patient, who received Moderna COVID-19 Vaccine and experienced feel freezing/ Hypothermia, temperature which read 104 degrees Fahrenheit/ Hyperpyrexia, feel cold/ Chills, she felt hot inside/ Feeling hot.  The patient's medical history was not provided.  On 08Feb2021, prior to the onset of events, the patient received their first of two planned  A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced the event(s) feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), feel cold, feel freezing, she felt hot inside, temperature which read 104 degrees fahrenheit was unknown.  doses of mRNA-1273 (batch number: 031L20A) via unknown route for COVID-19 infection prophylaxis. On 08Mar2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: 027A21A) via unknown route for COVID-19 infection prophylaxis.  On 09Mar2021, patient began to feel cold then went to the supermarket where she began to feel freezing and left, at  home although the heat was on, she still felt cold and resorted to wearing a winter jacket and two blankets still feeling freezing but oddly enough, she felt hot inside so she took her temperature which read 104 degrees Fahrenheit. She then proceeded to drink 1.5 cups of cold sparkling water and gradually these symptoms subsided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The Outcome of the event (Cold,Hyperthermia,Feeling hot, Chills) was considered to be not unknown at the time of this report.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded.
2sd dose   Symptoms sore arm at 430 pm - woke next day(day 2) not feeling well  - body ached arm very painful /headache/ fatigue Went back to bed woke at 4pm   Felt terrible with flu symptoms. Had fever of 101    Woke day 3 feeling exhausted temp back to 98.7  arm hot warm to touch and very painful.
Second dose of Hep A was given too soon.  Dose given on 03/04/2020 and should not have been given until 05/12/2020.  Error found on 03/11/2020. Medical director informed and client's guardian was informed. Client will get second dose after 05/12/2020 per client's guardian.
This spontaneous report as received from a medical assistant refers to a 15 year old patient of unknown gender. On 10-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L037339 with an expiration date 09-FEB-2018). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Within 24 hours post vax, pt developed a fever of 102F, "aches, pains" and an injection site reaction characterized by redness and swelling. On 3/8/01, pt reported "she feels much better."
Case number PHEH2014US020032 is an initial spontaneous report received from a pharmacist on 02 OCT 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) on 01 OCT 2014. On the same day, she had a little bit of bleeding when FLUVIRIN was administered. She was not on any blood thinners. She was okay last night (unspecified). The final outcome was reported as unknown. Causality and seriousness were not reported. But reporter "did not think this was a big deal". Reporter refused to provide any more details.
Patient is 11 years old - patient was schedule to receive the pediatric dose 0.2ml Pfizer Covid Vaccine but was mistakenly given the adult dose of 0.3ml.     There was no apparent or reportable adverse reaction to the larger dose.
couldn't move; throat closed; couldn't swallow; lethargic; chills; fever; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of MOVEMENT DISORDER (couldn't move), THROAT TIGHTNESS (throat closed) and DYSPHAGIA (couldn't swallow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Caller stated that she had COVID19 last April and she was hospitalized two times because she needed oxygen.) in April 2020 and Cancer (She is recovering from cancer, so she was reluctant to go to the hospital or call her doctor for her side effects.) since an unknown date.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MOVEMENT DISORDER (couldn't move) (seriousness criterion hospitalization), THROAT TIGHTNESS (throat closed) (seriousness criterion hospitalization) and DYSPHAGIA (couldn't swallow) (seriousness criterion hospitalization). On an unknown date, the patient experienced LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever). The patient was hospitalized on 01-Apr-2021 due to MOVEMENT DISORDER, then for 4 days due to DYSPHAGIA and THROAT TIGHTNESS. At the time of the report, MOVEMENT DISORDER (couldn't move), THROAT TIGHTNESS (throat closed), DYSPHAGIA (couldn't swallow), LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.
Chills, legs aching, diarrhea, vomiting, he ache, no energy. Still persists today on Sunday.
Extreme Fatigue, Shivering, Headache, Muscle Ache, Injection Site - Swelling, Heat, Redness, Muscle Soreness, Brain Fog, Loss of  Appetite, Nausea Increased Arthritis Pain in Joints Duration - 8 days Slight Relief of Muscular Ache with Asprin
Worker states patient's back became feverish and hot states she was limping right side. Saw massage therapist and chiropractor. States had sharp pain lumbar back radiating decrease right leg with numbness on tingling. Hx dislocated right hip 91 with screws.
This is a 43y.o. male who presents to ER due to chest pain.  The patient reported feeling the onset of his chest pain after playing with his child, who kicked him in the chest.  He came to the ER for further evaluation, concerned that he had "cracked a rib."  In the emergency department he was found to have a low level, but consistent troponin elevation.  However, looking back through his historical readings this is no significant change from his chronic troponin elevation.   He underwent a CT of the chest with PE protocol, which was positive for pulmonary emboli involving segmental and subsegmental branches of the right upper lung arterial vasculature with no evidence of heart strain.  He was also noted to have subtle peripheral groundglass opacities.  COVID-19 testing was performed and found to be positive.  He has never had a blood clot in the past, but there is a history of blood clots on his father side of the family.  He does not believe that a formal diagnosis has been made of any particular hypercoagulable state in these family members though.   He has been started on IV heparin   He has received the Pfizer vaccine x2   Additionally, he had some epigastric/upper abdominal pain.  He underwent a CT to evaluate this, which is significant only for circumferential bladder wall thickening due to underdistention versus infectious process.  Urinalysis has not yet been obtained, but has been ordered.
received bivalent booster. Pt reported to observation staff that she was not feeling well following Pfizer Bivalent vaccine. RN took vital signs. BP was 220/117 and tachycardic. Pt's vitals taken every five minutes. Pt remained in hypertensive crisis. 911 called. No previous hx of HTN.
Pt. received a Tdap & PNEUMOVAX & the night after the vaccines she developed fever, malaise, drenching sweats, chills, nausea & diarrhea. The injection site was markedly indurated, warm to the touch & measured 11x6 cm. Pt. was still feeling ill 12/14/11.
vomiting; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 04Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 05Jan2022, outcome "unknown", described as "vomiting"; HEADACHE (non-serious) with onset 05Jan2022, outcome "recovering", described as "headache".  Additional information: Reporter stated that her daughter, who was 35 years old, took her first dose of the Pfizer Covid Vaccine and then went out drinking and now had been vomiting all day. Reporter asked if vomiting was a reported side effect and if alcohol had any effect on the efficacy of the vaccine. Reporter also stated that her daughter had a headache but seems to be calming down now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
So I had started getting fevers every once in a while and became very fatigued so I went to my PCD and they did bloodwork and found I am anemic. Then I went to the rheumatologist and I was studied because I tested positive for an AMA. They didn't find anything further so I am back to seeing my PCD for the fatigue and anemia. I don't remember when I saw those DRs but it was post vaccination some time.
This spontaneous report was received from a registered nurse and refers to a 6-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB thimerosal-free, lot # R001530, expiration date 07-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (It was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose and route were unknown). On an unknown date after receiving GARDASIL 9, the patient developed the "flu" an unspecified time. The pharmacist stated that the unspecified patient had not received any additional doses of GARDASIL 9 yet. The outcome of the event was unknown. Additional information has been requested,
CDC reports: 6 mo infant developed fever to 104 & rash following immunization.
24 hr low grade temp followed by 12-24 hrs of 102-103T.
About 6 hours post vaccination, the patient developed a severe injection site reaction. The involved area was red, inflamed, swollen. The area was approximately the size of a softball. The patient's PCP diagnosed her with cellulitis & gave antibiotics.
Pt came for 1st moderna vaccine. Questions answered and Vaccine given to left deltoid. Checked on pt 2 times with door open and time set for 15 minutes.  10 seconds prior to alarm going off, I checked on pt and asked how he feels and pt states " I feel dizzy" while sitting in chair and became unresponsive. Pt taken to floor and called for help. Pt had no pulse, 911 called and cpr initiated for 20 seconds. Pt became responsive., diaphoretic, pulse 78, pulse ox 95% and b/p 176/ 80, EMS  arrived and took pt to medical center.
Developed malaise, inanition, mild confusion, sweats, and high fever following yellow fever vaccination.
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400070, PJP200400071, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
did not received the second dose of the Moderna vaccine and more tahn 42 days have gone by since first dose was administered.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna vaccine and more tahn 42 days have gone by since first dose was administered.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna vaccine and more tahn 42 days have gone by since first dose was administered.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not received the second dose of the Moderna vaccine and more tahn 42 days have gone by since first dose was administered.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
Pt began crying soon p/immun & cried 3.5 hrs non stop pitched shrill cry;