chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:49 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 21.81.  Concomitant products were not provided.  On 15-Apr-2021, excursion time was 9 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: not provided, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report as received from a consumer refers to a female patient of unknown age. No information regarding the patient's concurrent conditions, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date the patient was vaccinated with a human papilloma virus (HPV) vaccine, the type and manufacturer unknown, (Lot number, expiration date and route of administration were not reported). After the vaccination the patient became pregnant. The LMP and EDD is not known. The outcome of pregnancy is unknown.
"Here today for concern of possible reaction to vaccine. States that she is feeling warm and uncomfortable/tingling in her skin. No rashes, no spots. Got the shingles vaccine. Traveled to another city on Friday after she was here. Did not feel well once she got there. States that she was having some discomfort in the area just under the left side of her nose. Then she was having pain that was under the eyes. That facial discomfort persisted. Her face became swollen. Denied any increased work of breathing or swallowing issues. Developed abdominal pain, nausea, vomiting, diarrhea. Last night she had a lot of pressure in her chest - had a lot of gas and when she belched she would feel better. Denies any fevers. Still feels heat in her face." Provider's Notes.
Blood in urine 36 hours after vaccination; dose number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 07Dec2021 14:15 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was none. No Covid prior vaccination. No Covid tested post vaccination. No Known allergies. No other vaccine in four weeks. Concomitant medication(s) included: ALEVE; ESTRADIOL; PROGESTERONE (low dose HRT). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0183, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 15May2021, when the patient was 54 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0171, Location of injection: Arm Right, Vaccine Administration Time: 01:15 PM), administration date: 24Apr2021, when the patient was 54 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 07Dec2021, outcome "unknown", described as "dose number=3"; BLOOD URINE PRESENT (medically significant) with onset 09Dec2021 07:00, outcome "unknown", described as "Blood in urine 36 hours after vaccination". Therapeutic measures were not taken as a result of blood urine present.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022; Pharmacy gave Moderna Covid-19 vaccine past its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna Covid-19 vaccine past its beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 24 Jan 2022 and administered to the patient on 03 Mar 2022) outcome was unknown.  For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported.  It was reported that the patient received vaccine past the 30 days beyond use date after the vaccine was placed in the refrigerator on 24-Jan-2022. The pharmacist wrote an expiration date of 24-Mar-2022 on the Moderna Covid-19 vaccine instead of 24-Feb-2022. The reporter does not know which dose the patient received and on which arm the patient received the Moderna Covid-19 vaccine. No other adverse events or side effects were reported. Vial did not undergo any temperature excursion.  Treatment medications were not reported.
DEVELOPED SORE ARM THAT LASTED 1 DAY. ALSO HAD BAD FATIGUE AND HEAD PAIN LASTING UNTIL MORNING OF 1/10/21.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included shingles (APR2014) and herpes zoster over 20 years ago that resulted in left side facial paralysis. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX lot # K007989, expiration SEP-2015 subcutaneous. On 17-NOV-2014, the patient presented with complaints of symptomatic tingly feeling of shingles (onset 16-NOV-2014). It was reported that the patient had a blister on her left elbow. The outcome of tingly feeling of the shingles and left elbow blister was reported as not recovered/not resolved. Additional information has been requested.
Flu; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient (age and gender unknown) who experienced flu (Influenza), while received Influenza Vaccine.  Medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency-about 2 days), the patient got the flu (Influenza) following administration of INFLUENZA VACCINE. It was reported as event was so bad that the patient was sick for a full 2 weeks, couldn't even get out of bed. The patient never allowed anyone to give a shot and never had flu.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Numbness in left foot.  Initially in left ankle and toes as well, now just toes.  Occasional sharp pain in left ankle and in arch of foot.  Toes have been constantly numb for almost 3 months, there have been no times without numbness.  The pain comes and goes.  Pain and stiffness in both knees developed in November and continue with some days better than others.
A spontaneous report has been received from pharmacist concerning a female patient. No information regarding medical history, concomitant disease and concomitant medication was provied. Patient had received nasal FLUMIST (intranasal) for unknown indication, started on an unknown date. Pharmacist reported that we administered FLUMIST and the entire dose went in one nostril on 5-Oct-2014. The outcome of the event of entire syringe of FLUMIST administered in one nostril was unknown. Reporter considered the events of entire syringe of FLUMIST administered in one nostril to be non serious.
just a slight soreness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", described as "just a slight soreness".  Additional Information: After the 1st dose - just a slight soreness that lasted a few hours was all the result of the first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The day of the vaccine, pt started have a cough, weakness, racing heart and the feeling like she wasn't getting good breaths or enough oxygen- pt continue to have they symptoms 2 months later- after getting her second shot she felt even worse.
7 da post vaccination, headache, nightsweats;   10 da post vaccination, single sattelite lesion on right wrist, headache, nightsweats 11 da post vaccination, 2 additional sattelite lesions(one on back-3mm pustule; the other 2 cm above vacination site), headache, lessening nightsweats.  Lesions not itchy.  Patient afibrile, looks and feels well.  No hx of immunosuppression.
Wrong vaccine type given in error. Previously received the Pfizer COVID-19 vaccine on 4/21/2021 but given the Moderna COVID-19 vaccine by CVS today (5/12/2021) in error
I became very dizzy; vomiting; This is a spontaneous report from a contactable consumer, who is also the patient. This patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJ1685) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 26Dec2020 in the evening, the patient became very dizzy and was vomiting. The outcome of the events was unknown.
When I  put food in my mouth around 3pm and then again around 5pm, I felt burning/tingling in my mouth which quickly resolved.
Minimal acute sx, much less than doses #! & @. Then, ~2.5 months after the vaccination, I developed right calf superficial thrombophlebitis; no DVT on ultrasound.  Treatment with Rivaroxaban 10mg qhs x 6 weeks, and rest, heat, elevation, compression. I have very significant varicose veins x 30 years (since first pregnancy), but have never had thrombophlebitis or DVT.  I was not wearing compression stockings previously, but started after the diagnosis was made. I have finished the 6 wks of Rivaroxaban, no evidence of recurrence,. The thrombus is no longer palpable or tender.
04/17/12 Onset of achiness, runny nose, fever, and some nausea. Described as "flu-like feeling". C/O "feeling tired" et fatigue. States took OTC BENADRYL. Contacted clinic 04/18/12 d/t cont. c/o. VS stable, temp 97.9 temporal artery. Cont. OTC meds for symptoms.
PFS activated on 12Oct2022, administered on 23Oct2022; This case was reported by a nurse via call center representative and described the occurrence of wrong technique in device usage process in a female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 23rd October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced wrong technique in device usage process. On an unknown date, the outcome of the wrong technique in device usage process was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comments:  Nurse reported that the patient received a dose of Flulaval on 23rd October 2022 and that prefilled syringe was originally reconstituted (cap was removed and needle attached to it) on 12th October 2022.  The vaccine administration facility was the same as primary reporter. The reporter was consented to follow up.  Additional Supportive Information: The patient received a dose of Flulaval on 23rd October 2022 and that prefilled syringe was originally reconstituted (cap was removed and needle attached to it), which led to wrong technique in device usage process. This case had been linked with case US2022AMR161151, reported by the same reporter.; Sender's Comments:  US-GSK-US2022161284:Same reporter US-GSK-US2022AMR161151:Same reporter
Headache, Diarrhea, Stomach cramps, nausea Narrative:
Pt started to develop a rash throughout his body. MD was notified as soon as rash was seen by nursing staff and tx was ordered.
pt recv vax & c/o dyspnea, generalized rash & itching, fever of 101.0;pt referred to local Er;fever 101 w/in 24hr;
30 seconds after administration, syncope with transient tonic posturing. All symptoms resolved after 60 seconds. VSS throughout event.
Felt like the flu the day after, for one day only. Although I was rather dehydrated and I didn't make it any better by drinking on the night of the vaccine.
Pt received DTaP and MMRV in the left arm on 2/12/07.  On 2/13/07 pt started with fever and redness at the site of injection.  On 2/15 fever was still present, up to 104 and the redness on the left arm still 1in by 3 inches, no streaking.  No other symptoms besides fever.  Treated with Tylenol and ice to the area.  Told to come into the clinic on 2/16 to have the arm looked at to see if it is an infection, pt called and cancelled appt and said he was getting better on 2/16.
Blood sugar rose to 501one hour after vaccine.  It was 166 in the am Never has been that high Left arm vaccine rm tingled and numb all the way to finger tips
Fatigue, body aches, high fever, rash on feet and legs, swelling around eyes, severe headache, loss of appetite, weakness, chills.
Pfizer lot number was short-dated and we were unaware of this and administered an expired vaccine.
15 mins p/inject pt said felt dizzy but often felt that way; 30 mins later c/o being lightheaded, h/a; pt taken to ER BP 100/70, P62, color good, neuro signs were nl; dx rxn to Hep B inject; h/a, blurring vision;
Narrative:  Hospitalization, COVID positive and fully vaccinated upon admission, admitted for cough
Recurring fever of 100-101ºF lasting at least two days. Injection site swollen and red.
Change in taste, tingling of tongue Narrative: Tingling in tip of tongue developed in evening after vaccination, occasionally also felt on on sides of tongue. Also with metallic taste. Has sought care PCP, no treatment provided. Sensation persisted >2weeks.  Other Relevant History:
30 min after received vaccines presented with pink face, torso with erythema and multiple wheals, arms with few spots of erythema, no wheals, or wheeze, coughs and breath sounds clear with good airation & no wheeze, no wheal on face, and legs normal. Benadryl 1 tsp given orally 5 min after med given no cough or wheeze; erythema & wheals subsiding. 10 min after med given continued to improve with few spots erythema to arms. Home with parents to monitor and CB/ initiate 911 if reaction reoccur & to give Benadryl every 4 hours as needed.
After experiencing the expected side effects, such as fever, chills and body aches, I woke up the next day (two days after my second dose of Moderna vaccine) at 5:50 a.m. because I experienced chest pain and shortness of breath. I am concerned it may be myocarditis, and I have not seen a medical professional for this. I recovered after two days but sometimes experience pangs of chest pain time to time.
Large blackened patch like inflammed skin surrounding injection site with tenderness and pain even after 2 weeks of immunization, which developed couple of days after vaccination.
pt recvd vax 2AUG93 1045PM mom says pt was very fussy, had fever of 100 ax & had a petit mal sz-just stared; happened x 1; did not take to FMD; was giving APAP every 4 hrs; rt thigh inflammed & swollen @ inject site;
she is dying and by the end of this week she may not be alive; Sweating in the middle of the night like someone pour a glass in bed; Severe pain from the bones and muscle; throwing up; shivering at night; severe diarrhea that she had to go to the bathroom 24/7; no appetite; itchy face; nose was running that she uses 1 pack of Kleenex; felt like she wasn't a human being right now; could not exercise like she used to; losing her brain; cannot get up since she received the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face) and VOMITING (throwing up) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face), VOMITING (throwing up), RHINORRHOEA (nose was running that she uses 1 pack of Kleenex), FEELING ABNORMAL (felt like she wasn't a human being right now), ASTHENIA (could not exercise like she used to), MALAISE (losing her brain) and ASTHENIA (cannot get up since she received the 2nd shot). On an unknown date, the patient experienced FEELING ABNORMAL (she is dying and by the end of this week she may not be alive), NIGHT SWEATS (Sweating in the middle of the night like someone pour a glass in bed) and MUSCULOSKELETAL PAIN (Severe pain from the bones and muscle). At the time of the report, DIARRHOEA (severe diarrhea that she had to go to the bathroom 24/7), CHILLS (shivering at night), DECREASED APPETITE (no appetite), PRURITUS (itchy face), VOMITING (throwing up), RHINORRHOEA (nose was running that she uses 1 pack of Kleenex), FEELING ABNORMAL (felt like she wasn't a human being right now), ASTHENIA (could not exercise like she used to), MALAISE (losing her brain) and ASTHENIA (cannot get up since she received the 2nd shot) had not resolved and FEELING ABNORMAL (she is dying and by the end of this week she may not be alive), NIGHT SWEATS (Sweating in the middle of the night like someone pour a glass in bed) and MUSCULOSKELETAL PAIN (Severe pain from the bones and muscle) outcome was unknown.            Patient was prescribed by her doctor to take 1 Cholestyramine oral every day for diarrhea and Zofran for throwing up.
Mild and brief 4 day course of chickenpox (less than 20 spots) after past history of receiving vaccine.
Per various notes in chart: Comments: pt states she has started to develop a reaction from her second hep B injection. She has a rash and a fever of 102.4 she will come to walk in for eval. She is not having any problems breathing, sob, swelling in throat etc. Patient came to team II and reported that she had her second dose of Hepatitis B today (her at 0851) and started to feel dizzy at 1100 then her face started turning red and developed a rash on her jaw area. Will send to walk in clinic as provider has no available appts this time of day. Pt of Dr, no avail appts presents to walk in with c/o having an allergic reaction to her second Hep B vaccine, which was given here this morning at 9am, since then she has been lightheaded, dizzy, sweats, face getting red, and shaky. 29 year old female pt recd her 2nd immunization for hep B in the series and shortly thereafter developed hives, dizziness, mild shortness of breath. The hives have resolved and the only remaining finding is some mild erythema of the cheeks and submandibular area. Lung fields are clear bilaterally.
Erythema - raised area left upper deltoid at injection site - local reaction advised routine NSAIDS. Ice pack applied.
Local swelling of Left arm. VS WNL.  Icepack provided and edema/rash decreased.  Patient stable and released from the vaccination site.
I gave the patient the vaccine, and told her to wait and be seated so that we can monitor her for a possible allergic reaction. She sat down but then fainted 5 minutes later. She woke up after 30 to 40 seconds. I assessed to see if there was an allergic reaction but there was not. She said she had a prior history of fainting after recieving a shot. She refused any medical care. She sat down for 15 more minutes and left the pharmacy.
Patient doesn't remember exact date of vaccine. Next day, arm hurt from shoulder past the elbow. It turned pink, puffed up and itchy. Did not do anything to treat symptoms or seek help. Went to allergist for a scheduled appointment 5-6 days later. Doctor specified that it was a systemic reaction and patient should not take 2nd dose. Recommended to take BENADRYL as needed but patient did not take any meds. Symptoms resolved after 2 weeks.