chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Daptacel with an expired diluent was administered to a patient with no reported adverse event; Initial information was received on 15-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves 15 months old female patient to whom expired dose of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with an expired diluent was administered with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Mar-2023, the patient received a standard expired dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 ml total (lot C5816AA, expiry date- 26-FEB-2023) via intramuscular route in the left thigh for Immunization with an expired diluent was administered to a patient with no reported adverse event (expired product administered) (latency- same day). Caller is requesting validity information.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA085728:01533896
Left arm became very hot, red, swollen, in a large area,  for a period of apprx. 2 weeks.  Redness continued for another week.  Itching began during week two.  At one month, still had a small pink area and 2nd vaccination had to be done in right arm, at nurse pract.  advice.
Patient stated she developed redness below the injection site eight days after receiving her first Moderna vaccine.  The site was very itchy.  She applied Caladryl to alleviate.  The redness gradually dissipated over a couple days.
Laid on the floor after vaccine given with c/o feeling sick to stomach.  Flushed.  After laying on the floor for 10 min., sat in a chair for 20 min. and felt better.  Color came back to patient's face and smiling.
body rash, hands, feet, head; This is a spontaneous report from a non-contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ep6955), dose 1 via an unspecified route of administration at the age of 59-years administered in arm left on 25Mar2021 12:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body rash, hands, feet, head on 28Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not test covid post vaccination, did not receive treatment for event. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
PT REPORTED TIGHTNESS OF CHEST APPARENT LYMPH NODE SWELLING ON LEFT SIDE OF CHEST
Began approximately 8 hours after vaccine: chills, low-grade fever, and vomiting for 5 hours; headache and nausea for 48 hours. Tylenol, bedrest (24 hours), liquid diet (36 hours), fatigue 72 hours
I was pregnant the next day after receiving a covid vaccin I was carried by an ambulance to the hospital since then my health has been bad every time I go to the hospital until I had a premature baby all caused by Covid vaccin my due date was January 11 I did not make it my weight was 168 lbs nothing was wrong with my pregnancy after the 1 and 2 dose my health start deteriorating
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine administration time: 12:00 AM. No other medication in 2 weeks. Patient received Paxlovid for COVID 19 Treatment from 10Jun2023 to 15Jun2023, no known allergies and no other medical history.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Red rash about 1" wide by 3" long. No raised areas, no itching, tenderness or soreness. Appeared almost 1 week after injection. It is on my right side below my neck and slightly toward my right arm. I received the vaccine in my left arm. Area is not as red after about 36 hours of first appearance but still quite visible.
Vaccine admin 8/12/08 est. time 11:00 A.  Reported by patient's mother symptoms started later in day and overnight: sore at injection site, arm shaky, dizziness, nausea, pale, non-productive cough, as reported by patient's mother 2:00 p 8/13/08.  Patient by then had less symptoms and was improving; follow up call to patient 8/14/08, no symptoms or side effects.
pt recv vax same rxn p/3rd dose that was given in MD ofc couple days later called & informed the MD of adverse rxn; p/3rd vax pt noticed heart felt like beating rapidly could not relax felt hyper; did not sleep until 2AM;
11/5/12 Rash developed on thigh/buttock (L) appeared to be in > 1 dermal zone. 11/9 mult. small vesicles spreading - Herpes PCR (-) varicella zoster results on (+) 11/14/12, started on acyclovir 11/14.
Shot was given lower in arm than it should have been. There is a hard, warm and red bump where given.  Its starting to get itchy as well.
Pt had multiple chicken pox lesions (over 50) over body. Vaccine received in 1996.
Had flu shot Wednesday for 2 days had the a chest pains arm remained warm and red. Gradually started spreading redness. Each day it went a little further around arm.
The Bivalent booster was given based on the lot expiration date looked up on the Pfizer web site, which was 01/31/2024. Instead of using the past date of use date, 03/14/2023, which is 10 weeks after received and put in refrigerator.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2015, the patient was treated by the hospital (by an unspecified healthcare professional) for the onset of a vesicular rash, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the 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. The outcome of the herpes zoster was unknown. Causality assessment was related. Additional information has been requested.
Body aches, fever, chills, headache.  Came on approximately 6 hours after vaccination, subsided approximately 24 hours after vaccination.
Patient was given Fluzone HD PF 2020-2021.  Expired vaccine from last influenza season.  Expired 6-30-2021
Pain and swelling left upper arm. Itching. Rx'd with TOPICORT.
I experienced bronchitis and a bad cough that is stuck in the upper part of my lungs.
Pain in upper arm & shoulder about 5 hrs after shot - severe pain in moving arm any directions - cld Dr. on call on form given - was told should only last 24 hrs or less - cld own Dr. following day - same report - went away about 36 hrs - nurse checked on me next day after shot.
Patient was awakened at 2:30 am with complained of trouble breathing airway swollen and compromised. Hoarse voice, trouble swallowing. Taken to ER. Treated with Benadryl, Prednisone. H1 H2 blockers 10 day after H1N1 vaccine. Also complained of weakness in legs and dizziness. No new meds, food, soaps, etc. H1N1 vaccine only foreign substance in contact with still being treated.
Received Kinrixinstead of 4th DTap; 3 YO received Kinrix; Received Kinrixinstead of 4th DTap; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 04-AUG-2022, the patient received Kinrix. On 04-AUG-2022, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Received Kinrixinstead of 4th DTap), inappropriate age at vaccine administration (Verbatim: 3 YO received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Received Kinrixinstead of 4th DTap). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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: 21-Mar-2023 The nurse called to inform that 3-year-old patient had to receive the 4th dose of the DTap series but received a dose of Kinrix. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received kinrix instead of 4th dose of DTap at 3 years of age, which led to Wrong vaccine administered, Inappropriate schedule of vaccine administered and inappropriate age at vaccine administration.
High blood pressure 160/100, headache, diarrhea, weakness, painful swollen glands, chest discomfort
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 5 years old child patient and unknown gender. On 11-SEP-2014 the patient was vaccinated with (Merck) VARIVAX (lot J009002, expiration date 19-JUL-2015)(dose, route not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. The reporter also stated that as of 29-AUG-2014 they had 9 doses left of this lot number. This is one of several reports received from the same source. Additional information has been requested.
My husband (age 63 at time of shot) and I (age 61 at time of shot) both suffered ill effects from the Shingrix vaccine.  Part 1 was given at a pharmacy on 6.15.19 and Part 2 on 8.30.19.  For Part 1, I wife had some fever, tired side effect, but husband felt ill w/fever, body aches for about 3 days.  I think we informed our doctor, but don't think he reported it.  Didn't ask us questions.  For Part 2 shot, wife felt drastically ill - plastered to the couch, sleeping, horrible body aches, no appetite - so much my husband and I took turns getting a glass of water for each other - knowing we had to have water at least, even though we both didn't feel like drinking or eating.  Just sleeping and in pain.  Both of us started symptoms within hours of the shot.  Felt like death 1 whole day for me and 3 days for husband.  We have told our friends about the reaction and NOT to get the shot unless they felt they had to.  Husband vows not to get any more vaccines, except Tdap when needed.  We are both up to date on shots/vaccines.  I get flu shots. Husband will not - got sick after a flu shot years ago so he will not get again.  I get flu shots every year.  I even got Swine flu shot in 1976 w/no reaction.  I (wife) typically do not get reactions from any shots (other than arm discomfort), but with Shingrix EVEN I had an awful reaction.  Husband felt absolutely horrible.  We stayed at home on our couches and suffered.  Did not go to doctor or hospital.  Our daughter is a NICU nurse, but there was nothing she could do either.  You may email me if you need more information.
It was reported in a published article that a female patient was vaccinated on 1/27/92, 2 days after giving birth to a normal baby girl on 1/25/92, with a dose of MMR (second generation). It was noted that the patient was vaccinated in case (she had) more children. Subsequently, the patient became pregnant again. In 1996 the patient had a miscarriage. In conclusion, the author stated that vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins. No further information is available.
About 10 hours after 2nd dose of Pfizer COVID19 vaccine I developed a fever which spiked at about 102  couple hours later and went down to about 99-100 for about another 24 hours.  Today (2 days after 2nd dose) I am feeling fine.
My COVID-19 symptoms started on 12/01/2022 in the evening . I had a fever and I began to feel like I was coming down with a cold. On 12/02/2022 I took a COVID-19 home test which was positive, I went to the urgent care on 12/03/2022 . They prescribe me Paxlovid but told me that it was up to me to take it since they thought my symptoms wasn't severe. I did filled the prescription but I didn't take it.  After 1 month of contacting COVID-19 infection I started experiencing hearing loss on January. Couple  of days before  I felt my left ear was congested. I felt like there was fluids but I wasn't sure because I was in another state. When I came back in the evening I felt like I couldn't hear anything so in the morning I drove to the urgent care. They prescribe me oral Steroids and Antibiotics for 10 days. It did help but I still feel the hearing loss on my left ear. I went to my doctor's who then referred me to an ENT . They did MRI  on 03/2023 CAT-Scan 04/2023. . The CAT-scan didn't show anything significant. The hearing test showed that I had significant hearing loss on my left. I will be using  a hearing  aid soon. When I had the hearing loss I also developed  headaches.  If I strain in anyway I get extreme headaches. as of today I still feel the lingering headaches.
This spontaneous report as received from a pharmacist refers to a 75-year-old female patient with diabetes mellitus and allergy to sulfonamides (reported as "sulfa"). In approximately 2012 (reported as about 5 years ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided), reconstituted with sterile diluent (lot number and expiration date were not provided). Concomitant therapies included insulin and pain pills. On an unknown day (after administration of ZOSTAVAX), the patient might have had herpes zoster. At the time of the report, the patient did not have a rash or herpes zoster. The outcome of the event was reported as recovered on an unknown date. The relatedness between ZOSTAVAX and the event was not provided.
3 days after vaccine she developed a slight cough very slight runny nose. 2 days later she had a whistling cough and on the 3rd and 3th day after she broke out in a rash on her stomach & upper legs which quickly went away after cool bath and dose of Dipenhist however 18 days later she is still whiny a little grumpy and extremely tired and says she doesn't feel good. Teacher commented on her tiredness and says there's been a big change. I took her to a pediatrician who gave her something for cough but did no blood work even though I ask for it.
Pt said she had bleeding under her bandaid when she got home.  She has also had pain in her neck since the day she got the shot.  It can shot up from the injection site into her neck when she sits down at a computer.  She has taken pain relievers and used ice.  I told her to try heat.  If that doesn't work, she will need to call her dr.
I experienced severe exhaustion with an elevated temperature. I also experienced headaches with cough and congestion.
Patient received Gardasil 9 on 19-SEP-2022 and then had an allergic reaction; Rash at the injection site; This spontaneous report was received from Company Representative and refers to a 37-year-old female patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 19-SEP-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U037064, expiration date: 10-AUG-2024 (who had been verified to be a valid number), administered for prophylaxis on the right arm (strength and dose were not provided).  On 24-SEP-2022 (reported as 5 days later), the patient had an allergic reaction, the reaction consisted of swollen lips and eyes as well as a rash at the injection site (hypersensitivity-injection site rash). The outcome of the adverse events as well as the causality assessment with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were not provided.
On 01/20/2022 at 5:00PM I experienced flu like symptoms of myalgia, chills, and fatigue that resolved at 4:00PM the next day. On 01/27/2022 at 7:00PM I experienced a dull ache of pain that went up the left side of my neck up into my head, the pressure in my head increased for a pounding painful pressure and headache that lasted intensely for 2 minutes before lessening to a dull pain again down the left side of my neck. There was also pressure on my rib cage in the center of my sternum, which lasted for an hour. The dull ache and pressure in my head lasted until I sought care in the ER and was administered pain medication. All of the symptoms resolved within about 24 hours and have not returned. I did not receive a diagnosis for my adverse event.
This case was reported by a nurse via sales rep and described the occurrence of vomiting in a patient who received BEXSERO for prophylaxis. Co-suspect products included FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On an unknown date, the patient received Bexsero at an unknown dose and FLUARIX QUADRIVALENT 2018-2019 season at an unknown dose. On an unknown date, less than a year after receiving BEXSERO and FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced vomiting, headache, dizziness and fever. On an unknown date, the outcome of the vomiting, headache, dizziness and fever were unknown. It was unknown if the reporter considered the vomiting, headache, dizziness and fever to be related to BEXSERO and FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The nurse informed her Glaxosmithkline vaccine representative that the patient received both BEXSERO and FLUARIX at the same time and experienced heavy vomiting, fever, headache and dizziness. This case has been linked with US2018193567, reported by the same reporter.
After an half hour of observation patient c/o of light headedness.  Patient was laid down for 15 minutes and vitals were taken.  BP was 155/99.  At 345 PM nurse noted redness on cheeks and neck.  Denied itchiness, no noted SOB or difficulty swallowing.  On follow-up on 2/16/2021 Patient says she went home took Benadryl and rested.  Says she had chills, and headache throughout weekend but on Tuesday she was back to feel normal.
Patient received dose #1 of Pfizer for SARS-COV2 on 4/23/21. She had been on Rituxan, with last dose in March 2021. She was seen in urgent care with pulmonary complaints on 5/24/2021. She was admitted to the Hospital on 5/31/21 with COVID pneumonia and is now currently intubated.
Events started 11-30-09 - major tremors arms, legs, confusion (brief) episodes of blurry vision loss 40 seconds, tic like movements arms like pt. has a chill - these call occurs 5-30X per day, general malaise, twitchy sensations of skin. "Never loses consciousness w/tremors".
BELL'S PALSY; This spontaneous report received from a parent via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: breast cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: Unknown) dose, start therapy date were not reported administered 1 in total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, exactly 1 week before surgery the patient experienced bell's palsy. The reporter stated that daughter got her vaccine a few weeks before the start of treatment for breast cancer. The patient was recently done with chemo after several month. The patient has been in therapy for it for months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bell's palsy. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 13-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Additional information received is regarding amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).. This follow up information received does not alter the assessment of prior company causality of previously reported events.  20220232686-COVID-19 VACCINE AD26.COV2.S- Bell's palsy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Information has been received from a consumer concerning his son who on 10-DEC-2010 was vaccinated with GARDASIL (lot number not provided). On the same day the patient experienced itching, rash and fever after received GARDASIL. It was unknown if the patient sought medical attention. At time of the report, the patient's outcome was unknown. No further information is available.
My husband got Bells Palsy; This case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's comment: This case was reported by patient's wife via interactive digital media. The patient got Shingles vaccine and experienced bell's palsy which was one of the side effect.  Additional supportive information: Follow-up would not possible as no contact details were available.
Left upper arm red, swollen and warm to touch. Tx: Benadryl chewable tabs 1/2 tab every  hrs