chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles at a pharmacy. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a hospital for a persistent vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
(R) arm noted to be quite red, hot, swollen at site of varicella injection - worsened over a 2-3 day period -> improved with ice, BENADRYL.
diarrhea; muscle spasm; flu like symptoms; chills; stomach upset; fatigue; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN), PARACETAMOL (TYLENOL), CYCLOBENZAPRINE and LOPERAMIDE.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset), FATIGUE (fatigue) and MYALGIA (muscle pain). On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and MUSCLE SPASMS (muscle spasm). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset), FATIGUE (fatigue), MYALGIA (muscle pain), DIARRHOEA (diarrhea) and MUSCLE SPASMS (muscle spasm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to unspecified patients of unknown age and gender. The pharmacist reported that these unspecified patients may had received improperly stored ROTATEQ (lot#, dose not reported, orally) on an unknown date. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
TESTES HUNG LOW; BODY WAS WARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced testes hung low. On MAR-2021, the subject experienced body was warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from testes hung low, and body was warm on MAR-2021. This report was non-serious.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient recieved vaccine was waiting for about 5 minutes while other family members were recieving. She walked out of pharmacy to go sit down and fainted and hit her head on the floor before she got to the chair. She got up right away after faiting and sat in the chair. She was responsive.  911 was called and she was evauluated and released to leave with her family.
Mom reports child broke out in a rash on face and chest within a few hours and ran a temp. of 102.9 axillary.  Mom took child to Hosp. ER. ER Doctor told Mom it was probably a rxn to the flu shot and child may have an egg allergy.
On Friday evening, 24 hours after my 2nd vaccine, my left arm started to itch. My arm, underarm and left breast was very red, swollen, itchy,  tender to the touch and my arm felt sort of numb and weird.  Prior to feeling that way, I had a headache and the left side of my neck was tight and painful. I put some Benadryl gel and an ice pack on my arm and underarm. The following day it felt a little better but still had redness, swelling and itchiness. On Sunday when I went back to work, I had NP take a look at my arm. She felt I may have developed a cellulitis and prescribed Keflex 500mg QID x 7 days. Today, Monday, 2/15/2021, my arm is still a bit red and feels tight but is much better than it was on Friday and Saturday.
lightheaded, tingling on left side of face, tightness in calves, ankles, feet, swollen face, inside face swollen, legs swollen,couldnt breathe, wheezing
This shot GAVE me Shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included measles (never had chickenpox, only the measles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shingles after getting the Shingles shot. The patient hoped that vaccine was better today than when it 1st came out. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Pt recvd 1st dose of Hep B vax in approx JUL92; approx 2 to 3 wks later, pt exp lightheadedness, joint pain & devel a low grade fever & an inc white blood count; pt hospitalized 24AUG92;
Redness and warmth to right upper arm that radiates from upper arm to forearm 5 minutes after administration. Patient was monitored for 30 minutes after which redness subsided.
VACCINE GIVEN FROM VIAL THAT WAS GIVEN 20 HOURS AFTER INITIAL PUNCTURE; VIAL WAS USED AFTER THE RECOMMENDED STORAGE TIME/ IMPROPER ADMINISTRATION; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine given froml that was given 20 hours after initial puncture, and vial was used after the recommended storage time/ improper administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given froml that was given 20 hours after initial puncture and vial was used after the recommended storage time/ improper administration was not reported. This report was non-serious.
On August 04, 2021, I had severe itching and rash on the left upper side of my back. I had a virtual visit with the doctor on Monday, 08/09/2021 and it was diagnosed as shingles. She prescribed antiviral for 7 days, I don't remember the name. By the end of the 7 days it was getting better. Within a week after completing the medication, it completely resolved. I don't feel like there is any relationship with me getting shingles and the Moderna vaccine.
It began with a scratchy throat on Monday evening following the Saturday Vaccine and I ran a temp for the next three days with it reaching a spike of 101.  I also was congested and had chills, headache and extreme fatigue. Now I still get a slight evening temp and I'm still dealing with the congestion/allergy - especially in the evenings.  It's now been about 10 days since receiving  the first vaccine.  I'm very nervous about receiving a second injection.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 06-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 156 hours (sum of hours in excursion). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Left upper arem redness and swelling and tenderness x 4.5 days after vaccination.  Rx heat/ cold/ Advil
Uticaria - hives, rash, bumpy skin, itching, redness, blistering Treatment -  prednisone, benadryl, cetaphil cream, cortisone cream Outcomes - Three episodes of hives in two weeks.  Four more episodes in the following two months--the most recent episode 4 days ago.
Had high fever up to 103. I had fluid in my lungs. I had a chronic cough. I had headaches. They gave me an inhaler. I got cough medication to loosen up mucous in my chest - it came out different colors. I had a lot of congestion in my chest and constant coughing all day long. I coughed so much that you could see blood coming out from the mucous in my chest. I went to ER for the treatment.
Case number PHEH2016US004385 is an initial spontaneous report received from a pharmacist on 18 Feb 2016. This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number and expiry date: not reported) intramuscularly on 04 Feb 2016. The vaccine might have been used for the patient after the 1.1 C (Celsius) excursion for 1 hour and 39 minutes on 04 Feb 2016. On 16 Feb 2016, FLUVIRIN preservative free syringes reached 12.4 C for up to 1 hour and 36 minutes. No adverse event was reported following  this medication error (incorrect storage of drug).
This spontaneous report was received from a medical assistant and refers to an unknown number of unspecified patients. Since August 2015 (reported as "for the past two years"), the patients were vaccinated with improperly stored doses of VARIVAX (dose, route of administration, lot# and expiration date were not reported) for prophylaxis reconstituted with sterile diluent. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA013510: US-009507513-1708USA012799.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot #K004205 with expiration date 12-JAN-2017; lot# K008931 with expiration date 04-MAR-2017 and lot# L006459 with expiration date 06-APR-2017, dose, dose# and route unknown). No symptoms reported. The vaccines were stored under 9 C for 1 hour and 15 minutes without previous temperature excursion. No doses were administered past labeled expiry. This is one of several reports received from the same source. Additional information has been requested.
end up in bed for several days are the years that I got the flu shot and every year that I didn't get the flu shot I didn't get sick at all; Initial information received on 24-Nov-2022 regarding an unsolicited valid social media non-serious case received from a Patient   This case involves an unknown age and unknown gender patient who experienced end up in bed for several days are the years that i got the flu shot and every year that i didn't get the flu shot i didn't get sick at all after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer(strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunization).  On an unknown date the patient developed a non-serious event end up in bed for several days are the years that i got the flu shot and every year that i didn't get the flu shot i didn't get sick at all (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine.Author/Reporter Comment: The only years that I end up in bed for several days are the years that I got the flu shot and every year that I didn't get the flu shot I didn't get sick at all so no more flu shots and I haven't been sick.  It was unknown if there were lab data/results available.  Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event end up in bed for several days are the years that i got the flu shot and every year that i didn't get the flu shot i didn't get sick at all.
2nd day chills and fever 3rd and consecutive days fever (104) chills, fatigue, headache, vomiting diahrea  lasted until approximately 3/20/21
Full body muscle aches, upset stomach, fever (100.5),( normal temp is 97.6)
Upon awakening, small raised red areas noted on leg and arms. At 10am, babysitter called and staated infant had larger size raised red areas over all body-feet, arms, trunk, back. Would fade with oral Benedral and repeat within 5 hrs. Wheezing noted. No imporvement with con't Benedryl, temp 99.7 deg. F. Taken to ER on 02/09/2002. Raised red areas faded by 02/09/2002.
Floaters, flashers began 8/25, vaccinated with dose #1 on 8/31. Eyelid swelling and discomfort  onset of 9/16/22, better by 9/17/22. Eyelid irritation/swelling has resolved. 9/20 - reports continued flashes in corner of R eye Floater remains in R eye to this day.
No adverse event; 01May2023, for their 2nd dose of the Covid-19 vaccine.previous dose was Pfizer but since they do not have Pfizer available,they gave the Moderna bivalent vaccine.1st dose was administered on 05Apr2023 bivalent; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01May2023, for their 2nd dose of the Covid-19 vaccine.previous dose was Pfizer but since they do not have Pfizer available,they gave the Moderna bivalent vaccine.1st dose was administered on 05Apr2023 bivalent) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1) on 05-Apr-2023. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 01-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01May2023, for their 2nd dose of the Covid-19 vaccine.previous dose was Pfizer but since they do not have Pfizer available,they gave the Moderna bivalent vaccine.1st dose was administered on 05Apr2023 bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01May2023, for their 2nd dose of the Covid-19 vaccine.previous dose was Pfizer but since they do not have Pfizer available,they gave the Moderna bivalent vaccine.1st dose was administered on 05Apr2023 bivalent) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01May2023, for their 2nd dose of the Covid-19 vaccine.previous dose was Pfizer but since they do not have Pfizer available,they gave the Moderna bivalent vaccine.1st dose was administered on 05Apr2023 bivalent).    No concomitant medications was provided. No treatment medications was provided. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.
received expired Moderna Covid-19 vaccineon 31 Jan 2022 and 26 Apr 2022; greater than 35 days in between first two  doses of the Moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccineon 31 Jan 2022 and 26 Apr 2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days in between first two  doses of the Moderna Covid-19 vaccine.) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days in between first two  doses of the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccineon 31 Jan 2022 and 26 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccineon 31 Jan 2022 and 26 Apr 2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days in between first two  doses of the Moderna Covid-19 vaccine.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.  Patient received her first dose 31-JAN-2022 31-DEC-2021 lot number 026D21A expiration date 26-JAN-2022.  Event expired vaccine received onset dates were reported as 31 Jan 2022 and 26 Apr 2022.  No Adverse Reactions or Side Effects were reported.
sleeplessness; generalized aching; leg discomfort; axillary pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleeplessness), PAIN (generalized aching), LIMB DISCOMFORT (leg discomfort) and AXILLARY PAIN (axillary pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    No Medical History information was reported.   On 17-Feb-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 80 mg. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced AXILLARY PAIN (axillary pain). On 26-May-2021, the patient experienced INSOMNIA (sleeplessness), PAIN (generalized aching) and LIMB DISCOMFORT (leg discomfort). At the time of the report, INSOMNIA (sleeplessness), PAIN (generalized aching), LIMB DISCOMFORT (leg discomfort) and AXILLARY PAIN (axillary pain) was resolving.        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.   Daily dose of co suspect humira is on day 1 80 mg,1 in 1 once and on Day 8 40 mg,1 in 1 once was reported.
Extreme pain during vaccination.  Worsening pain and would wake me when I rolled on to my arm for 4 days.  Evolved into joint pain that would not resolve with medication.   Developed a loss of range of motion and pain that mimicked a rotator cuff tear.  This worsened over months.  Doctor prescribed meds and PT.  After PT I suffered a partial tear of the biceps tendon.  MRI pending.  Shoulder pain improved after the tear.
Itching and urticaria on back about one hour after vaccination. Mother of Patient gave Benadryl, providing relief. Symptoms lasted 3 days.
patient fainted about 1 minute after administration, came around a minute or 2 later, and left feeling fine about 15 minutes after that
Patient became very grey and sweaty.  I laid him down and put a pillow under his head with an ice pack with feet up on the bench.  I gave him apple juice and graham crackers as he had not had lunch prior to his appointment today.  He remained laying down for approximately 15 minutes and drank two apple juice.  I them sat him up for a few minutes and then slowly had him stand.  He was able to leave with his mother, stating that he was feeling fine and felt he could leave.
10cm localized rash at injection site; dizziness after injection occurred during 15 minute observation period. 50mg diphenhydramine IM administered. Dr, MD consulted. Patient improved over additional 30 minutes, vitals stable. Patient declined further intervention.