chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to 16 patients.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Large rash emerged on inside of lower left leg (starting ½ from knee to just above ankle), about 8-9 hours after receiving injection. Treated with hydrocortisone cream, to minimal effect. Rash lasted roughly 6 weeks. The following day, symptoms included fatigue, chills and 2 rounds of vomiting. Treated as flu virus. Slept/rested most of 36 hours, plenty of liquids. Still felt logy but mostly 80% recovered by the 2nd morning after injection. Back to normal (other than rash on leg) by 3rd morning.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL3247), in right arm, on 14Apr2021 as dose 2, single (Lot number: FK9895), in right arm, on 05Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left leg and on 12Jan2022 as dose 4 (booster), single (Lot number: EL9264) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "High cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: Covid-19 rebound after takin Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Patient received COVID 19 treatment as Paxlovid from 25Sep2022 to 29Sep2022. Patient did not received other medication in 2weeks.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # T003384, expiration date was reported as 27-JAN-2022 but upon internal validation established as 28-JAN-2022; lot # T007231, expiration date was reported as 26-FEB-2022 but upon internal validation established as 27-FEB-2022; lot # S023656, expiration date was reported as 29-JUL-2021 but upon internal validation established as 30-JUL-2021; lot # S039313, expiration date was reported as 03-DEC-2021 but upon internal validation established as 04-DEC-2021) underwent a temperature excursion.  09-JUN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine underwent a temperature excursion as it was stored at 47.2 Fahrenheit (F) (above 46 F) for 52 minutes, recorded by digital data logger. There was no previous temperature excursion. No additional adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Information has been received from a pharmacist concerning a 44 year old female with bipolar disorder and a history of recurrent herpes zoster who on 19-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck) subcutaneously.  Concomitant therapy included gabapentin, LYRICA and DEPAKOTE.  The patient developed a large, red, warm area around the injection site of the right upper arm on 20-DEC-2007, 1 day after receiving Zostavax (Oka/Merck) on 19-DEC-2007.  The patient first contacted the pharmacist by phone at the end of December 2007 and the symptoms were resolving without treatment at that time.  In early February 2008, the patient developed lower right flank pain.  She was examined by her physician on 11-FEB-2008 and was found to have an enlarged liver.  Liver function test results were elevated.  The patient had not recovered.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008.  Initial and follow-up information has been received from a pharmacist concerning a 44 year old female with bipolar disorder and a history of chronic shingles with no outbreak at the time of vaccination who on 19-DEC-2007 at 11:45 am was vaccinated SC in the left arm (injection site also reported as right arm) with a first dose of ZOSTAVAX (Merck) (lot # 658604/1088u). Concomitant therapy included VALTREX, PROVIGIL, CYMBALTA, estradiol and baclofen. On 20-DEC-2007 the patient developed a large, red, spot covering the under side of the majority of her upper arm, very warm to the touch, which started to decrease. The patient had pain at her liver area and went to see her physician for it on 11-Feb-2008. The patient was examined and found to have an enlarged liver, the physician performed liver function tests, and the patient said the results were elevated since test last performed in SEPT 2007. On 14-FEB-2008 the patient inquired as to if the vaccine caused enlarged live, and increased liver tests/enzymes. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information has been requested. This is in follow-up to report(s) submitted on 1/26/2008, 6/24/2008. Concomitant therapy included gabapentin, LYRICA, DEPAKOTE, VALTREX, PROVIGIL, CYMBALTA, estradiol and baclofen. Follow up information was received from the patient indicated she had a chronic fatigue and shingles recurrent at the time of vaccination. Her liver enzymes became elevated 3 months after vaccination. On approximately 12-OCT-2007 last documented liver function test was done and the result indicated that ALT 49, AST 42 and ALK phosphate 92. Another laboratory test was drawn in March by another physician but no results were provided. Additional information is not
Patient was observed going down the stairs with an unsteady gait. Patient observed leaning on  one side, and then falling back into a sitting position onto stairs. RSA's assisted resident to dining  room. Patient later observed not being able to ambulate, and needing to be pushed in wheelchair.
Acute autoimmune response Weakness on left side Unable to walk or lift left hand and arm Spent 5 days in the hospital, 4 emergency room visits Seeing a rheumatologist and in physical therapy  Currently taking daily prednisone just to be able to move.
I have enough nerve pain as it is; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 21-Jul-2022 Reporter's comment: The case was reported by the consumer via interactive digital media. The patient reported that he/she had first shot with no sore arm at all.  The patient did not want shingles. The patient had enough nerve pain as it was. The follow-up could not be possible as no contact details were available.
Mouth and lips swollen. Blister appeared on upper lip. Mouth felt numb. No treatment.
Full body hives came up about 3 days after the vaccine. They first appeared on my legs, then also on arms and trunk.  They improved with diphenhydramine but did not resolve. For about the next month (to the date of submitting this report), I have continue to have hives unless I continuously take higher doses of antihistamine - at least 50-100 mg of diphenhydramine in divided doses daily. I have done two rounds of 5 days of prednisone dose-down packs. The hives completely resolve when one the prednisone, but return a few days after it stops. I have never had any SOB, chest tightness, or other issues.
Attempted to get out of bed to go potty and slid to floor unable to stand on legs, daughter and grandson had to help put me back to bed, went to emergency room and they couldn't figure out what was wrong but with assistance from nursing was able to walk. I came home and pretty much slept all day. The next day was weak, sore all over and had a headache
severe nausea and vomiting for four hours. Aches and chills and fever.
Rash on skull, light pink, moved to my left upper arm then to my right arm . Second shot 02/08/2021, starting to itch and dry out my skin.
She got her vaccine, had no reaction.  The next day she woke up with a really bad headache.  It is throbbing, and the shooting pain goes down her spine.  She has contacted her doctor and has an appointment on 9/8/23.  She has taken Tylenol for her symptoms, and is still having the headache.   She also has flu symptoms.  She did have COVID on 8/14/23 and never got tested, but her mother was positive for COVID.  She had flu-like symptoms, but no sharp headaches, achy body and rested and was good in about a week.  She had a temperature of 100, and took Tylenol for it.  That headache was nothing like she has now, and it was on file that she did have COVID 2 weeks prior to the vaccine, but they gave it to her anyway.
I experienced general body aches and fatigue. Then I experienced intense pain centering on jaw/parotid location. Felt like anaphylaxis, but no difficulty breathing or swelling in area of breathing. Swelling was in face. This lasted at least 48 hours. Alternated taking Tylenol and ibuprofen for the course of 48 hour period.
Redness, muscle pain, swelling bilateral thighs - more swelling in (L).
Flushing, generalized itching,  conjunctival injection, nasal congestion, dry cough
Patient had onset of R sided facial droop 1d after receiving her second COVID vaccine. 3d after the vaccine she presented to hospital and was found to have a L MCA stroke
Patient vaccinated with Moderna COVID-19 in March and April 2021. Symptoms started 12/13/2021: Nasal congestion and extreme fatigue. Client still has extreme fatigue as of 1/2/2022. Received infusion of monoclonal antibodies on 12/26/2021.
Extremely cold (teeth chattering)  - followed by hot flashes, and 101 fever. Headache and body aches. Very tired and no energy.  treatment - rest, Advil and Tylenol (not at the same time) - drank extra water to.  Symptoms lasted a day - now just minor headaches - still taking Tylenol
NauseaVomiting SOB, fatigue, back ache, neck pain, fatigue Narrative:
MOC reported that 6hr p/vax pt devel hives over 80% of bilat lower extremities, trunk, arms, face & neck;pt was seen in ER & sent home;
Generalized myalgia; tenderness of R upper arm; fatigue;  low grade fever; joint pain (R shoulder, base of neck,  bilateral hip joints)
Approximately 45 minutes after injection, when I had already left the clinic,  I became lightheaded and weak.  I experienced some tightness in my chest but no difficulty breathing or rapid heartbeat.  Experienced sensation of burning/tightness around the periphery of my face.  Symptoms dissipated after about an hour.
This spontaneous report as received from a Doctor of Pharmacy refers to an old male patient in his 60's. The patient was vaccinated SC. with ZOSTAVAX, 0.65 ml, on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist mentioned that the patient was "very muscular", so he was not able to administer the vaccine subcutaneously in the deltoid region of the upper arm, and the closest site he could find for subcutaneous injection was in the lower triceps region several inches above the elbow. No adverse event reported. It was unknown if the patient had sought medical attention. Additional information is not expected.
Nausea nausea started about 10 hours after receiving the 3rd dose; was given an extra Shingrix vaccine /  3rd Shingrix vaccine on 01-29-2021; first Shingrix vaccine on 8/20/2018 / second Shingrix vaccine was given on 9-28-2020; This case was reported by a consumer and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose on 20th August 2018 ).   On 29th January 2021, the patient received the 3rd dose of Shingrix. On 28th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In January 2021, the patient experienced nausea and extra dose administered. On an unknown date, the outcome of the nausea was not recovered/not resolved and the outcome of the extra dose administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose late than recommended shedule which led to  drug dose administration interval too long. The patient received an extra Shingrix vaccine which led extra dose administered. The nausea started about 10 hours after receiving the 3rd dose that has not resolved till the time of reporting. The reporter did not consent to follow-up.
Bell's Palsy as evidenced by left neck pain and left facial weakness.  Experience sx for 4 days before presenting to ER.  Dispensed acyclovir and prednisone and referred patient elsewhere.
It seems like it set my immune system into overdrive. After the first dose I had swelling / numbness in my face and jaw. Then I got hives. I have continued to get hives every day now for 5 weeks , since the first dose. I have to take antihistamines every day. I took an antihistamine prior to the second dose and did not get swelling , but still got, and continue to have hives. Secondly,   Having rheumatoid arthritis,, I have had severe joint pain in most joints, bilaterally since the first dose. Worse than I have every had before, this has sent me into the worst flare, with pain and fatigue , than I have ever had in my life.
Moderna Covid-19 Vaccine EUA  At the site of injection, it is swollen, tender (hurts when I touch it), I have redness, and it itches a little bit. Seems like a rash.
The same day as vax, the pt experienced hives and was sick. He experienced one episode of vomiting,  and appeared a little clingy. He was treated with Benadryl with some relief. He was referred to a clinic.
missed second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient stated that if he/she missed 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Very severe insomnia, worsening depression and anxiety. Double the Cerequil. Prescribed a sleep aid. Won't take it because it can cause sleep driving.
I felt like I was coming down with a cold. After getting home from vacation, during that trip my granddaughter had a cold so I did not think too much of it. After two days I was not feeling better so I took a COVID-19 Home Test and it was positive. I started having a fever and was just not doing better so I called my Doctor and I was put on Paxlovid. That resolved all symptoms other than being tired.
Approximately 2 months after receiving the Moderna Booster shot, Patient started with extreme itching (puritus).  Although he has seen 4 doctors, and had numerous  tests and exams, no one knows why his body has produced excessive eosinophils that have resulted in itching all over his body (arms, legs, chest, back, abdomen)  without any rash.  This itching has interfered with sleep and his entire well being.   It is now April 29, and itching persists.
Patient inadvertently given lower "booster" dose instead of higher dose recommended for unvaccinated children.
patient came into the pharmacy and showed me  his arm and it was red around the injection site.  i asked when he had gotten the vaccine and he said it had been a week. upon further investigation it had been 2 days. i told him that you can have pain swelling and redness around the injection site. I asked had he done any cold compresses or anything to it and he said no. he actually still had the bandaid on his arm. he said he would try that for the next couple of days and if it didnt get better he would go to his doctors office.
Per mom pt developed blood in her stool 2 days after vaccination. Pt was seen in the ER and in our office. Pt's symptoms resolved per mom on 11/25.
pt recv vax;slept x 4 hr p/ shot;woke up w/ high pitch cry for over 3 hr;PC to PMD;was to take pt in er;mom denied fever or changes in LOC;inject site of dtp inflamed & tender;mom was told by er MD that pt had rxn to dtp;
pt recv vax 17NOV97 & 17NOV97 shortly p/vax pt exp dizziness;pt was kept for observation;approx 2hr p/being discharged pt felt lightheaded w/numbness to fingers;pt returned to MD c/o numbness in t arm & hand;pt unable to work;
Patient described very severe pain in the injected area, swelling, and tenderness to the touch 24 hours after administration.. After follow up the next day, he was feeling much better.
SHINGLES VACCINE - Rash on back initially, now spreading to stomach, arms.  Headache, horseness, chills. Patient unable to work. Patient went to a dermatologist the day following the vaccination and was given Famciclovir (generic for Famvir), 500mg to be taken 3 times a day for 7 days. This has not helped at all.
Severe pain and welling of lymph nodes located in arm pit of vaccinated arm - lasted 5 days.  Heavy metallic taste in mouth. Vomiting, headache, body aches.
Chills, myalgia, headache lasting approximately 18 hours from onset. Some fatigue but not main symptom.
This case was reported by a other health professional via call center representative and described the occurrence of malaise in a adult male patient who received RABAVERT. Concomitant products included Typhoid vaccine, live oral. On an unknown date, the patient received the 1st dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, the patient experienced malaise and headache. On an unknown date, the outcome of the malaise and headache were recovered/resolved. The reporter considered the malaise and headache to be probably related to RABAVERT. Additional details were provided as follows: This case was reported by a physician assistant. The age at vaccination was not reported. The healthcare professional (HCP) reported that the patient experienced malaise and a mild headache for 24 hours after dose of pre-exposure RABAVERT. The HCP did not have vaccine lot number or expiry date information with her at the time of reporting. This case was linked with US2018GSK089078, reported by the same reporter for the 2nd dose of SHINGRIX.
Five days post vax, he experienced a sore and raspy throat, colored mucous, and cough. He was dx with an upper respiratory infection. Symptoms resolved by 3/22/00.
Patient got vaccine at appt around 11am started getting tired around 2pm. She got a fever, drowsy and could not keep eyes open at all. She said that night she felt like that, she does not remember coming home that day. She said she never felt the shot go in, it didn't hurt at that time. She still feels very drowsy and no energy at all. She said she had been sleeping all week and it's not like her.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.