chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022; 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022; Patient had 0.5 ml booster dose instead of 0.25ml; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022), ACCIDENTAL OVERDOSE (Patient had 0.5 ml booster dose instead of 0.25ml) and PRODUCT STORAGE ERROR (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 9:59 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Jan-2022 at 9:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022) and ACCIDENTAL OVERDOSE (Patient had 0.5 ml booster dose instead of 0.25ml). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022), ACCIDENTAL OVERDOSE (Patient had 0.5 ml booster dose instead of 0.25ml) and PRODUCT STORAGE ERROR (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Moderna vaccine pulled from freezer on 12/16/2021. date of 01/15/2022. On 1/26/2022, staff brought it to attention that it was still in the fridge and expired and given 5 doses to the patients.  No concomitant products were reported. No treatment drugs were reported
3FEB93 fever 101 R noticed-small red bumps around inject site; 6FEB93 brought in by mom states area around inject site larger-rash sl raised; no hard area;
pain; lmited strength in right arm; right arm injection site pain which has continued to point of sore arm/right arm pain of injection site began immediately and is still ongoing.; sore arm limited strength in right arm,; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), ASTHENIA (lmited strength in right arm), VACCINATION SITE PAIN (right arm injection site pain which has continued to point of sore arm/right arm pain of injection site began immediately and is still ongoing.) and MYALGIA (sore arm limited strength in right arm,) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 012A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, SIMVASTATIN and GLIPIZIDE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain), ASTHENIA (lmited strength in right arm), VACCINATION SITE PAIN (right arm injection site pain which has continued to point of sore arm/right arm pain of injection site began immediately and is still ongoing.) and MYALGIA (sore arm limited strength in right arm,). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (pain), ASTHENIA (lmited strength in right arm) and MYALGIA (sore arm limited strength in right arm,) outcome was unknown and VACCINATION SITE PAIN (right arm injection site pain which has continued to point of sore arm/right arm pain of injection site began immediately and is still ongoing.) had not resolved.            Treatment medication included oils for injection site.  It was reported that patient is very active and still working.   This case was linked to MOD-2021-311219 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Significant FU received on 14-SEP-2021,contain Reporter Address,Patient Height,Weight,Race and AE Outcome. On 14-Sep-2021: Contains NNI
Patient stated that after waiting 15 minutes post injection and leaving, she began to experience throat closing while driving in her car. Patient voiced that she took Benadryl immediately and the reaction began to subside. The patient also stated that he woke up Saturday evening with a large sized knot on her arm where the vaccine was administered. Patient stated that it has since gone down in size but is still fairly large.
Information has been received from a physician concerning his mother in her 70's who was vaccinated with a dose of ZOSTAVAX intramuscularly by his sister who is a registered nurse by mistake. Subsequently the patient experienced lightheaded and pain at site. It was uknown if the patient sought any medical attention. The outcome of the patient's experience was unknown. The physician felt that pain with the injection was caused by the needle and not the vaccine. This is a consolidation of two reports concerning the same patient. No further information is available.
Significant localized swelling and erythema at the injection sites of each vaccine.  Developed 48 hours after injection.
Redness swelling began with blisters localized to R thigh around shot site, approximately 4cm diameter circle lesions various sizes. Infection secondary to itching site.
A couple minutes after the dose  When I was sitting there I got this overwhelming hot/tingling sensation all over my body like started in my head and went down to my toes. I got super dizzy and thought I was going to pass out. It was hard to breathe so pulled my mask down under my nose and just started taking deep breathes. I?ve never had that before and it was kinda scary. Happened twice while sitting there.
A lit report described pt who devel fever w/chills & myalgia 1 day p/vax;4wk post vax exp ear pain, h/a, blurry vision rt eye & lt eye;visual acuity 25/50 in rt eye 20/25 in lt eye;optic discs edematous;vasculopathy r/t neuropathy
Mild upper arm splotchy redness (not itchy) Skin overall itchy mainly upper calves, mid-back, Clavicle bone area. used cortisone cream. Thought it was dry winter skin but gone 2 days. I do get mild itch by clavicle after Keytruda.
Seriousness criteria other medically significant (OMIC). Initial report received on 08 December 2006 from a health care professional. A 46 year old female patient had received an intramuscular injection of Fluzone, lot number U2215AA, on a date between 14 November 2006 and 18 November 2006. There was no illness at the time of vaccination. the reporter was unsure of past medical history, but the patient dose take Singulair and Effexor. on 18 November 2006, the patient was diagnosed with Bell's Palsy. The event required examination by a physician. She was treated with prednisone and Lacrilube. relevant diagnostic testing included CBC, sedimentation rate, and Lyme test. Results were not provided. Recovery status was not reported.
pt recvd vax; pt exp severe jaw pain & could not chew or speak; pt had abcess in her tooth;
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium
symptoms were fever, chills, body aches and nausea that last 3.5 days.
I had juvadurm lip filler in December 2020. Less the 48 hours after getting the second shot my upper lip began swelling.  Took Benadryl and it continued to swell. Went to local urgent care and got a steroid shot and a prescription for prednisone for 5 days.
fever, irritability, erythema, pain/tenderness, swelling, warmth x 3 days;
HEADACHE; FEVER; COVID VACCINE REACTION; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 160 pounds, and height was 190.5 centimeters. The patient's concurrent conditions included sterilization, anxiety, depression, rheumatoid arthritis, sulfa allergy manifested by hives, and iodine allergy manifested by hives. The patient was previously treated with iodine, and sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine; and experienced drug allergy when treated with diphenhydramine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 15 days, from 2018 for rheumatoid arthritis. Concomitant medications included clonazepam for anxiety, bupropion hydrochloride for depression, fluoxetine hydrochloride for depression, and metoprolol succinate for high blood pressure. On APR-2021, the subject experienced covid vaccine reaction.  On 08-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid vaccine reaction on APR-2021, and fever, and headache on 13-APR-2021. This report was non-serious.
fever, arm rash, aching muscles, movement in arm of vaccine severly impacted was unable to move it for two weeks
Syncope. Patient passed out briefly after pfizer vaccine.  Patient said he felt dizzy, tried to stand up to alert pharmacy and passed out.  He fell from his chair to the floor and regained consciousness before pharmacist made it to his side. Patient was asked if he need additional care, such as an ambulance, the patient declined. Patient remained seated in pharmacy for approximately 40 minutes. Over the course of 40 minutes the patient was checked in on by pharmacy staff and drank a gatorade.  Patient denied having any injury from his incident. Patient left pharmacy on his own.
Irregular heartbeat/palpitations  Severe Headache  Nausea Fever 101 Severe body aches/pains Severe pain  in glands under left arm Fatigued
Vertigo, nausea, tinnitus  Started 3 days after COVID vaccination  Started 6 days after flu vaccination  I?ve Never had a reaction to either before  aside from a sore arm with both and a day of fever/chills after the second Covid vaccine.  This is terrible quality of life! I?m unable to exercise and afraid to move. Just rolling over in bed causes the room to spin and feel like I?ll vomit. I wish I hadn?t taken the vaccine.
Information has been received on 17-OCT-2016 from an office administrator referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not reported. The administrator is reporting a dose of PROQUAD (possible lot# L044055 expiration 02-MAY-2017, M010478 expiration 01-SEP-2017 or M021731 expiration 29-OCT-2017) and a dose of VARIVAX (possible lot # M010484 expiration 01-MAR-2018, M024702 expiration 18-MAY-201 expiration 18-MAY-2018, M004328 expiration 26-JAN-2018 or M009766 expiration 23-FEB-2018), that had been improperly stored, were inadvertently administered on 14-OCT-2016. No adverse effects reported, No further information provided. On the same day, the administrator has reported that after further review that only one dose of VARIVAX (M010484 expiration 01-MAR-2018) was administered to the patient on 14-OCT-2016. No other improperly stored vaccines were administered. No adverse effect reported. No additional information was available. Additional information has been requested.
Pt recv vax on 10/20/98; on 10/23/98 pt exp burning/soreness at vax site x 3 day
Initial misuse report received from a nurse on 03-October-2013. The 16-year-old patient had received FLUZONE ID. No adverse event was reported. List of documents held by sender: none.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent medical drug allergies of the patient were not reported. On 04-DEC-2015 at time- 02:17, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L025738 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.7 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Extreme knee pain.  Had double knee replacement 6 years ago and Friday, the day after the vaccine I could barely walk.  Standing up from a sitting position was extremely difficult.  Took tylenol every six hours to ease the discomfort.  On Sunday no problems in my knees at all.
(L) shoulder pain, warm to touch, firm and tender to palp, "knot" to (L) delt
Day after receiving second moderna dose, while at work patient omplained of headache and feeling dizzy while sitting at her work station. Pale color, skin warm to touch. Assisted to floor.  Brief loss of consciousness and gradually responded  to questions.. SaO2 98-99% on room air with pulse 60-70.  B/P 118/78 lying.  Finger stick blood sugar 124.  EMS called to respond.  Increased responsiveness and states had COVID immunization second dose yesterday. This AM her legs ached.  Had taken ibuprofen for symptoms.  Has not eaten food today but has been drinking fluids.   Report given to EMS on arrival and care transferred. Reported patient  is at home sleeping, plans to return to work 1/28.
Information has been received from a medical assistant referring to two patients of unknown age and gender. No information of pertinent medical history, drug reactions/allergies and concomitant medication were provided. On an unknown dates, the patients were vaccinated with a improperly stored dose of VARIVAX, (lot # L034368, expiration date 08-SEP-2017, strength, dose and route were unknown). No adverse effects was reported. It was unspecified if the patients sought medical attention. This is one of two reports received from the same source. Additional information has been requested.
States that the arm vaccine was administered in has been sore for 1 month (since vaccine was given).
Delayed reaction to the shot 8 days after. Soreness in arm hot, itchy , swollen and painful. 3 days later pain had stopped but right arm out swollen.
pt recv vax & devel large bruise @ Td inj site;area was about 3" x 1";area hot & tender to touch;had a knot;
This spontaneous report was received from a registered nurse refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified  patient's were vaccinated with improperly stored doses (incorrect product storage) of (Oka/Merck) VARIVAX (lot, expiry date and dosage regimen was unknown for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Developed rash, swelling, and warmth to touch at the injection site.  2 days later awoke to pain on inspiration, difficulty breathing which was dx'd by MD as pleurisy. 1 week after pleurisy developed swelling and pain in right elbow and dx'd with bursititis for which she was hospitalized.
07/23/2021 RIGHT ARM  ....10/15/2021 LEFT ARM BRUISE RED AREA HIVES ...
ANKLE STARTED TO SWELL AND BECAME HOT, RED; SOME BLISTERS APPEARED ON ANKLE; HEART RACING; LEG CRAMPING; STOMACH HURTING; ARM FELT FUNNY; This spontaneous report received from a patient concerned a 64 year old female. 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: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced heart racing. On 27-AUG-2021, the patient experienced leg cramping. On 27-AUG-2021, the patient experienced stomach hurting. On 27-AUG-2021, the patient experienced arm felt funny. On 28-AUG-2021, the patient experienced ankle started to swell and became hot, red. On 28-AUG-2021, the patient experienced some blisters appeared on ankle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg cramping, heart racing, stomach hurting, arm felt funny, ankle started to swell and became hot, red and some blisters appeared on ankle was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Experiencing an increase in smell and in taste; Experiencing an increase in smell and in taste; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Experiencing an increase in smell and in taste) and DYSGEUSIA (Experiencing an increase in smell and in taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (Experiencing an increase in smell and in taste) and DYSGEUSIA (Experiencing an increase in smell and in taste). At the time of the report, PAROSMIA (Experiencing an increase in smell and in taste) and DYSGEUSIA (Experiencing an increase in smell and in taste) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) I have never tested positive prior to receiving the first injection..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Entire thigh swelling extending from hip to knee beginning ~ 6 hours post vaccine.  Has tolerated influenza vaccine in prior years.
Child left clinic site p/waiting 30 mins began to cry @ home (within 1 hr of immun.) & would not stop leg red & sl swelling x 1 day to MD stopped cry p/4hrs MD reported to Hlth Dpt as a rxn.
Initial report received from a consumer who was the patient, on 10 January 2012. A female patient (age and birth date not reported) received an injection (route and site not reported) of TYPHIM VI, sanofi pasteur SA lot number not reported, in April 2011 (date not provided). The patient had a history of Typhoid disease in the past. The patient had no illnesses at the time of vaccination. The patient has intestinal gas after eating ever since the vaccine. The outcome was not recovered. Documents held by sender: None.
devel hives, swollen eyes & lips; 72 hrs p/vax treated w/DPH & Atarax syrup x 3 days;
I don't want to blame my health events on the vaccine but on June 21st of 2022 a stressful event occurred in my life and I knew it was effecting me but I didn't realize how bad it was until 06/24 when I was told by an ENT that my blood pressure was very high. I went to see my doctor and it was still high. She advised that I monitor my blood pressure and if it got to anything higher than 140 over 90 consistently for 2 days to begin taking a medication that she prescribed. I monitored for two days and my readings continued to be high so I've been taking 10mg of amlodipine daily since 07/17/2022. The readings of my blood pressure have improved but are still high. I've only had 1 reading in the advised range since beginning the medication.
1-28-16 Area (1" x 1 1/2") of redness noted at injection site. 2-2-16 Area (13cm x 16cm) of redness and warmth at injection site. 2-3-16 Area assessed by Dr.: Lg. red well demarcated area Kw/mild warmth. Local rxn to vaccine, no tx needed. Treatment: TYLENOL, CLARITIN, Naproxen, cold compress.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Flu vaccination: flu vaccine (5 years ago she had an allergic reaction to a flu vaccine which caused severe swelling and approximately 1 year ago she experienced a less severe version of this reaction.).Past adverse reactions to the above products included Swelling with flu vaccine. Concomitant products included WARFARIN, AMLODIPINE, POTASSIUM CHLORIDE (POTASSIUM [POTASSIUM CHLORIDE]), FUROSEMIDE and PARACETAMOL (TYLENOL) for an unknown indication.   On 13-May-2021 at 6:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection arm). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Soreness at injection arm) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment was not reported.
Hives all over arms, legs, neck, back, and chest for a couple of hours. The hives started at 9:00 PM, about 4 hours after receiving the vaccine, and were gone when the patient woke up the next morning.
pt rec vax 20JUL98 & 22JUL pt had red dots on back, legs & buttocks;devel white head, turned brown dark becamea blue raised nodule formed opened & dained clear;MD notified;tx w/ATB for spiders bites;
he was a little bit swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (he was a little bit swollen) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (he was a little bit swollen). At the time of the report, SWELLING (he was a little bit swollen) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  Treatment information was not provided. Patient was not an alcoholic or a smoker. After the first dose Patient was a little bit swollen for a couple of days and after that it had resolved.   This case was linked to MOD-2021-418161 (Patient Link).
Patient received vaccine on 12/2/02. At approximately 3PM, patient with red, swollen, tender to touch, localized reaction. Benadryl every 6 hours and warm, moist packs.