chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C; Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 19-Feb-2021, Pfizer vaccine on 12-Mar-2021 and Pfizer vaccine on 02-Nov-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 15-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion happened for 15 mins at the site +1.9 C) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Storage condition of the vaccine at the time of the excursion was reported as stored in the refrigerator. The vial undergo temperature excursions of plus1.9C to plus 6.4 C.\ with excursion duration of 15 min. Number of doses or vials were 2. Date and time vial was first punctured was on 15 Jun 2022 at 9.15 AM. Total amount of time the vial was exposed to room temperature range 8° to 25°C= 46° to 77°F.  No treatment medication were reported.   This case was linked to MOD-2022-590514, MOD-2022-590536 (Patient Link).
About 5 min after receiving vaccine - had just sat down after vaccine and had a weird sensation: like felt like rushed through my body and then instantly my heart started racing and I felt it thump into my throat. Let nurse in attendance know and she took me to another area secluded from others and told me to relax. Sat down. Hooked me up to monitors; blood pressure cuff  and  finger pulse and she left to go get someone and she brought EMT back with her. Felt tight in chest; in neck felt like there's tightening; but could still breathe; felt heavy: chest. Neck felt tight. Felt like I needed an inhaler. I don't have it with me as I only have asthma in spring and fall. They kept telling me to calm down and I wasn't feeling nervous. I was trying to relax. EMT asked questions and he said that the same thing happened to him. He told me I couldn't leave  Event Center until things calmed down for me. Released her when I felt fine but was just really tired and kind of shaky. I felt so exhausted. Told EMT that and he told me he would feel that way if he had just ran a marathon. I had slept 12 hours the night before. He didn't tell me what my heartrate went up to.  I left event center  at 9:49 pm. Started feeling strange again when doing errands and was at store afterwards (about 30 or 40 min later) - nauseous; dizzy; sweaty, clammy. Heart was racing again. I told husband I didn't feel right. Felt like I needed to sit because I was shaky. Left and went to vehicle. As we sat in car, I told him something wasn't feeling right. Mouth was so dry. He started driving. I felt like we were driving down a tunnel.Husband looked at me and said you don't look right either. Took me to ER in nearest hospital: blood pressure high; heart rate elevated; ER           (Hospital) The doctor did lab work. Triponin levels elevated; potassium levels low - sign of a heart episode and needed to get in control. Gave me potassium and took  more blood work and troponin levels started coming down. Dr advised me not to go back to get second dose. Personal Care Dr confirmed that I shouldn't get the 2nd dose - put in my records that I am allergic to this vaccine.  The next day I had severe diarrhea and terrible pain in my arm that went all the way down and up into my neck and whole right side head hurt. (really bad headache). Extreme fatigue. Went back to work on the following Monday evening and was exhausted doing my job. When I say family Dr on Tuesday, I didn't want to be taken off work because I was in the right place where people could take care of me and I'd taken time off at holidays. That entire week was a lot of exhaustion and tiredness.
Erythema of leg from thigh to calf, swelling of right knee.  Resolved by next day.  3 days later onset of rash starting on thighs and spread to whole body, concerning for serum sickness like reaction, hives, or erythema multiforme.
Pt developed varicella, confirmed clinically by physician. On the first day of illness the pt had 20 lesions. Several were classic dew drop petal vesicular lesions. Present on trunk and beginning on extremities. Very pruritic.
Severe depression started on the second day of my symptoms. It has lessened with time but more than a month later, I?m still suffering from it daily.
Sore arm; fever; fatigue; This is a spontaneous report received from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm, fatigue and fever after use of product. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient reported chills that started the evening of the vaccination.  Stated he felt better the next day.
Hep B vaccine was accidentally administered instead of Hep A. No sxs has been reported. Medical professional and PCP has been informed of the mistake. Medical professional advised to call clinic or go to Urgent care if patient has a reaction.
I got my shot at 1:05pm. 15-20 min later as I was leaving vaccination site, I felt throat tightness (like the feeling of a sore throat), left earlobe felt swollen, lower left of face felt tingly and swollen. My face felt flush. 5 min later symptoms went away on its own- face no longer felt swollen, but throat still felt tight/ like a lump in my throat. Around 6:30pm I felt throat tightness more pronounced plus feet tingling. I took Benadryl 50mg dose and throat tightness/ lump went away. I fell alseep around 9 pm and no longer felt any of these symptoms in the morning.
Described the beginning of a red dot about size of a dime with painful to the touch beginning on 11/15/20 and reported to us on the 16th. Spoke with patient again on 11/17/20 doing better regarding pain in the area but with some redness still in area of injection. Patient will call if any further problems occur.
Hospitalization: admitted 8/22/2022; discharged 8/25/2022. Presentation to the ED: dizziness and generalized weakness, chest pain, tachycardia.  COVID-19 + date: 8/22/22. Treatment: IV remdesivir, Decadron, ceftriaxone & azithromycin. Nebulizer therapy.  Discharge to: Home-Health Care Svc
never received the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (never received the second dose) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-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 (never received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (never received the second dose) outcome was unknown.        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 and treatment medication was reported by patient.
LETHARGY; LUMP UNDER INJECTION SITE; TENDERNESS; ARM SORENESS; LITTLE HEAT RADIATING FROM THE INJECTION SIDE; FEVER; NAUSEA; INJECTION SITE REDNESS; CHILLS; BODY ACHE; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included depression, weight loss, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 14:30 at left deltoid for prophylactic vaccination. Concomitant medications included valaciclovir hydrochloride for depression, vortioxetine hydrobromide for depression, and phentermine for weight loss. On 20-MAR-2021, the subject experienced body ache. On 20-MAR-2021 23:30, the subject experienced chills. On 20-MAR-2021 23:30, the subject experienced injection site redness. On 20-MAR-2021 23:30, the subject experienced fever. On 20-MAR-2021 23:30, the subject experienced nausea. On 21-MAR-2021, the subject experienced lethargy. On 21-MAR-2021, the subject experienced lump under injection site. On 21-MAR-2021, the subject experienced tenderness. On 21-MAR-2021, the subject experienced arm soreness. On 21-MAR-2021, the subject experienced little heat radiating from the injection side. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy on 28-MAR-2021, body ache on 22-MAR-2021 23:30, chills, fever, and nausea on 22-MAR-2021, and injection site redness, was recovering from lump under injection site, arm soreness, and tenderness, and had not recovered from little heat radiating from the injection side. This report was non-serious.
Pt seen in clinic 2 days after receivng vaccine. Right upper arm w/ erythema 7.5x4 cm in diameter, warm to the touch. Firm to touch. No drainage. Start Clindamycin HCl 300mg.
Fever from 12:00am on 1/4/2022 through about 9:00pm 1/4/2022 that was treated twice with Ibuprofen. Fever subsided for a time period after each Ibuprofen treatment.  Symmetrical rash between and under breasts around 8:00am 1/5/2022 and beginning to spread slightly up my breasts and on my back around 12:30pm same day. Rash is not uncomfortable or itchy. Have not treated at all thus far.
This female subject was enrolled in the prophylactic open study. On 10/23/06, she received a dose of influenza vaccine (lot # AFLUA201A, IM, LA). On 10/23/06, about 30 minutes after the 1st dose of Fluarix, this 50 year old subject developed cardiac pain, shortness of breath, and headache and was hospitalized. The pain was intermittent. Her blood pressure was 127/77 and pulse rate 75. She was put on oxygen therapy. Chest was clear. Myocardial infarction was ruled out. The subject was on no concomitant medications. The events were unresolved at the time of reporting. The investigator considered that there was a reasonable possibility that the cardiac pain, shortness of breath and headache may have been caused by influenza vaccine and that the events were possibly due to study participation.
Celluitis developed around injection site.  Red rash spreading.  4.5" x 4.5".  Reaction was normal on Day 1, red rash spread on Day 2.  Then consulted doctor (virtual visit) who prescribed Cephalexin 500MG 3x/daily for celluitis.
massive nausea; headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; WELLBUTRIN. Past drug history included: Reglan, reaction(s): "known allergies: Reglan". The following information was reported: NAUSEA (non-serious) with onset 29Dec2020, outcome "not recovered", described as "massive nausea"; HEADACHE (non-serious) with onset 29Dec2020, outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, headache.  Additional information: Facility type vaccine: Hospital. If other vaccine in four weeks: Unknown. First dose, massive nausea and headache. Have had daily headaches since first dose. If covid prior vaccination: No. If covid tested post vaccination: Yes. Known allergies: Reglan. Other medical history: Hypothyroidism  The lot number for bnt162b2 was not provided and will be requested during follow up.
Dizziness & Headache Narrative:  Dizzy, headache; resolved  Other Relevant History:
Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; The vial was initially stored in the refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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 EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) 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 EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022).    Concomitant medication was not provided.  It was reported that the vial size was 0.4 ml per vial. The vial was initially stored in refrigerator on 23-Dec-2022. The vial did not undergo any temperature excursion. Treatment information was not provided.  This case contains information for the 25th patient out of 42 pediatric patients as described by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
site of DTP inject was red & sore, low grade fever 2 days p/immun; redness inferior to inject site, following muscle group, tender, warm to touch; pt seen by MD typical react or cellulitis;
Chest pain, high blood pressure, troponin elevation with negative coronary angiogram consistent with myocarditis.
Heart palpitations; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products MACITENTAN (OPSUMIT) for an unknown indication and TREPROSTINIL SODIUM (REMODULIN) for Pulmonary hypertension.    Concurrent medical conditions included Pulmonary hypertension (secondary pulmonary arterial hypertension). Concomitant products included RIOCIGUAT (ADEMPAS) for an unknown indication.   On 15-Aug-2019, the patient started TREPROSTINIL SODIUM (REMODULIN) (Subcutaneous) .068 microgram/kilogram. On 20-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started MACITENTAN (OPSUMIT) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PALPITATIONS (Heart palpitations) and INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, PALPITATIONS (Heart palpitations) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Patient was on Remodulin since 15AUG2019 for secondary pulmonary arterial hypertension. On an unreported date in Apr 2021, the patient experienced the events of heart palpitations (palpitations) and flu like symptoms after COVID vaccination.
VACCINE ADMINISTERED TO A 17 YEAR OLD MALE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2128A21A expiry: 21-DEC-2021) dose was not reported, administered on 28-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-OCT-2021, the patient experienced vaccine administered to a 17 year old male. On 28-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to a 17 year old male and off label use was not reported. This report was non-serious.
Just basically I have blood pressure elevation, I did not experience high BP prior to the vaccine and now I do, that's pretty much it. Blood pressure monitored regularly due to having home health aides.
This spontaneous report as received from a registered nurse refers to a 61 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (Lot #, dose and route not reported) on an unspecified date. On an unknown date the patient experienced a local reaction at the injection site after administration of ZOSTAVAX. Hospitalization was not required. It was not known if the patient sought for medical attention. At the time of this report the injection site reaction had resolved. This is one of several reports received from a same source. Additional information is not expected.
Injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 23rd February 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-FEB-2023 Reporter's Comments: The reporter was the patient's wife.  The reporter mentioned her husband received his first Shingrix dose one day before reporting and experienced injection site soreness. Nothing else was reported. The reporter did not consent to follow-up.
36-year old female presents with 3 day(s) of mild rash that is worsening. Patient has associated rash (small patch if vesicular rash between shoulder blades), and erythema. Patient denies chills, fatigue, fever, swelling, itch (skin), drainage, and warmth.  PMH Herpes Zoster 20 years ago; rash on back similar to current outbreak. Had COVID-19 Pfizer COVID-19 vaccination second dose 3 weeks ago.  TREATMENT: valacyclovir 1 gm. 3x per day for 7 days. When blisters break keep skin clean and dry.
Patient Recieved Flu shot on 10/16/19 in Left thigh. Patient complained of pain that night, but no redness. Next day left thigh was a little red and daycare circled the spot. The day after the area redness, hotness and grew more painful
On 8/10/10 Patient came with L deltoid erythema all around slightly swollen, warm and tender to touch. Patient stated that during weekend she had high fever, difficulty moving that arm. Ceftriaxone 500mg IM given and Doxyciclin 100 mg twice a day p.o ordered. Temp 97.8.
gave Shingrix diluent only without mixing it with powder; gave Shingrix diluent only without mixing it with powder; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07 July 2022 Reporter's Comments:  Nurse reported nursing staff gave Shingrix diluent only without mixing it with powder. The reporter declined to answer any further questions when asked for consent to follow-up refused to answer the question. Additional supportive information As patient received only Shingrix diluent only without mixing it with powder which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Within 5 to 6 mins, patient noticed arm pain in the OPPOSITE arm. Injection was given in right arm, he stated there was some "pain" in the left arm.
pt recv vax in ER @ 1130PM on 9MAY95 for inc t103-104; pt had a febrile convuls while in ER; pt adm to hosp for observation x 2 days; No further incidents of convuls;
Immediately after the injection had  a weird tingling sensation in the back of my throat.  Asked for water was able to swallow.  They offered me Benadryl I was afraid to take because I wanted to go back to work, took Claritin 10mg po then approximately 30 mins later I, felt warm flush throughout body starting at left side of arm moving to feet and  continued to feel the tingling feeling in throat and redness and itchy feeling on left side of abdomen.  I was given 50 mg Benadryl po and sent to the ER. I received 60 mg of steriods and Medrol dose pack. The hot red flushed feeling and itching on abdomen was present until Saturday afternoon.  Saturday also experience fever 101., shaking chills and itchy throat.  Remain on Medrol dose pack and taking Claritin 10mg every day..
Slightly confused and incoherent...went to bed for a couple of hours...called doc and doc told her plenty of fluids.  No true black out.
7 days post my 1st dose, injection site became itchy, red, and feverish