chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 30-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer (office staff). This case involves a 12 months old male patient who was administered an expired dose of ACT-HIB lot UI799AA, expiry date: 08-Jul-2018, via intramuscular route in the left thigh on 30-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunisation; MMR for Immunisation; and VARICELLA VACCINE for Immunisation. It was a case of actual medication error due to expired vaccine used. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch  number XC534, expiry date 4th July 2020). On 4th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In April 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain and injection site muscle. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site macule were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site macule to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a red, blotchy, painful area at the injection site. There was no doctor visit, hospitalization or intervention was required. The symptoms were not considered to be life threatening or disabling. The healthcare professional was unsure of the exact onset of the patient's symptoms after the vaccine was administered.
IPOL was expired and they administered it, no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health professional via Medical Information (Reference number- 00463171) and transmitted to Sanofi on 05-Feb-2021.  This case involves an 16 months old male  patient who was given an expired 0.5 ml fourth dose of IPV (VERO) [IPOL] (Multidose vial, lot P1F491M, expiration date-30-Nov-2020) via unknown route in the left arm for prophylactic vaccination on 05-Feb-2021 (expired product administered).  The patient's past vaccination(s) included PediaRix respectively at 2 months, 4 months and 6 months.  The patient's medical history, past medical treatment(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); HIB VACCINE CONJ (TET TOX) (ACTHIB); and  DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP).   Also reported that there must have been an extra dose in the punctured vial. The vial got mixed up and they used it incorrectly.  It was a case of actual medication error due to expired vaccine used (Same day latency).  It was not reported whether the patient had any adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Severe asthma, the worst he has ever had.  Not controllable by medicine for the first time.
68 yrs old male with past medical history significant for Parkinson's disease (s/p DBS placement) and HTN who presented with left lower extremity weakness, which progressed to involve the LUE and left face.
itching in the arm, high blood pressure (114/99 mmHg) 107 , headache, pulse 107,  panic  attack,  fainting
Some chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Some chills) and FATIGUE (Fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Multiple sclerosis and Blood pressure.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced CHILLS (Some chills) and FATIGUE (Fatigue). In February 2021, CHILLS (Some chills) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included medications for Blood pressure and Multiple sclerosis. No treatment was received for symptoms.   This case was linked to MOD-2021-364929 (Patient Link).
This is a spontaneous report by a non-contactable physician. A 2-month-old patient received PREVNAR 13 on unknown date for immunization. Relevant medical history concomitant medication was unknown. On unknown date, the patient developed fever at 103 degree within 24 hours of administering PRFEVNAR 13. At the time of the report the clinical outcome of above mentioned event was unknown. No follow-up attempts possible. No further information expected.
2/22/2023 I had abdominal pain that was around my stomach, sides and up my back. I have had kidney stones before. It continued the next day. I went to urgent care, and I had a 1mm stone in my right ureter. I was admitted to the hospital and a lithotripsy was performed. I had a repeat of the same procedure three weeks later, because there was still remnants of the stone.
Information has been received from a Licensed Practical Nurse concerning a patient's friend who was vaccinated with GARDASIL and developed Bell's Palsy. No specified symptoms, duration, or treatment reported. No other information was available. Additional information has been requested.
Post vax, I began with severe chills, sweats, headaches, dizziness, dry throat, swollen glands (left arm pit) about 6/2/00. On 6/9/00, bullseye rash appeared. I saw a doctor on 6/12/00 and was given doxycycline
I had developed a large egg size swelling on my arm left arm at the injection site.  It was hot, inflamed, extremely painful. There was also a quarter size cluster of blisters on my right foot.  They itched and hurt.  I called the advice nurse and was told that I could not have a reaction to the shot that quickly.  After several more days where the swelling and pain got worse on  the arm and foot I insisted on seeing a doctor.  On 08/28/2014 I was seen by a doctor who told me I had developed shingles from the shot.
3:00pm 10-18-07 pain in right arm and around injection site. 7:00pm 10-18-07 swelling of area, red and indurated spreading to back of arm and down to elbow. Diarrhea, cold sweats and slight SOB. Benadryl 50mg QID; Prednisone 20mg BID x 2 days then 1/day x 2 days.
Blood pressure spike, took a month to get back to normal with meds. Stuffy ears/constant headache/tinnitus, still on-going.
Patient describes a new onset pain in her right upper arm beginning 1/18/21 (10 days after immunization) characterized by arm pain, swelling, and pain to the touch.
mom recv vax 21JUL95 & 2wk later found out was pregnant WAES95080867;APR96 delivered child w/jaundice & a lung problem;@ time of report pt was @ home doing well;
Fatigue, warm, flush, chills, headache, loose stools, tired.  Lasted for 4 days.
Significant chest pain and shortness of breath that started 4 days after the vaccine. Additionally, sensation of heart skipping beats and then beating "hard." Pain was better with sitting forward. Determination of acute pericarditis was made by an infectious disease consultant in the hospital. Pain marginally improved with NSAIDs but is still persisting.
Pt received shingles vaccine @ approx 9:30 am on 3/12/09. R arm. Pt called 3/17/09 @ 10:30 am to report R arm soreness and pain that wraps around the entire R arm. Plus overall feeling of "yuckiness". No treatment for soreness given at time of call. Pt wonders if shingles vaccine and oral acyclavir (taken on same day) interacted? R arm pain lasted "several" days.
When pulling needle out of patient's arm, patient bleed more than usual. Blood pooled under the skin at the site of injection and the area of injection swelled. Bleeding stopped quickly with cotton ball and pressure. Area bruised. Called pt a few hours later said area swelled pretty good but has since went down. But area is bruised. Pt also was experiencing some chills.
malaise; tiredness; painful itchy circular blister like rash on her back at the base of her spine; painful itchy circular blister like rash on her back at the base of her spine; painful circular blister; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced malaise, tiredness, itchy rash, blistery rash and pain. On an unknown date, the outcome of the malaise and tiredness were recovered/resolved and the outcome of the itchy rash, blistery rash and pain were not recovered/not resolved.   It was unknown if the reporter considered the malaise, tiredness, itchy rash, blistery rash and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022  Reporter's Comments: The patient had her a dose of Shingrix and experienced malaise, tiredness, and a painful itchy circular blister like rash on her back at the base of her spine.  The reporter was given medical disclaimer.  Referred to health care professional (HCP).  Spoke per package insert (PI) and content.  Offered after call survey. The reporter consented to follow up.
lightheaded, dizzy, and felt like her heart was racing; on exam pulse was 70 BPM, BP 140/80.  She waited for 30 min post vaccine.  Her symptoms resolved after reclining in a chair for 15 min.
Patient stated that she awoke in the middle of the night on 10/24 with night sweats. She then developed a fever of 99.7 with a headache and extreme joint pain. 10/25/2021 brought a little relief but still low grade fever. Today (10/26) she is still weak and  shaky. She is still having extreme joint pain and a headache as well.
12/25 10 pm: Chills, fever 100.2 congestion, slight cough, headache 12/26 1 pm: Chills, fatigue, 100.3, headache, fatigue 12/27 1:00 am: fever 102.5, headache, nasal congestion, fever broke after motrin, at 6am. 12/28- 11:00, chills, fever 100.2,  fatigue, mild headache
On July 23, 2022, two days after the second dose of Moderna vaccine (first dose was also Moderna and was administered by the same provider, on June 22, 2022), the patient's parents noticed depigmentation of the skin on the backs of the patient's hands.  Previously there had been no known sites of depigmentation on the patient's body.  As of Sep 1, 2022, the skin condition has not changed significantly since first appearance.
This case was reported by a pharmacist via call center representative and described the occurrence of aphthous stomatitis in a 76-year-old male patient who received SHINGRIX (batch number 9349T, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of aphthous ulcer (1st dose received on 2nd June 2018, refer case US2018174603).  On 8th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced aphthous stomatitis. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the aphthous stomatitis was unknown.  It was unknown if the reporter considered the aphthous stomatitis to be related to SHINGRIX. Additional details were provided as follows: The patient reported to the pharmacist that he developed canker sores on his mouth again after 2nd dose of SHINGRIX.
Pain and swelling with redness at injection site. Headache, muscle ache, fatigue. All symptoms lasted 3 days, except pain and swollen lump at injection site which lasted 5 days.
This spontaneous report as received from a Medical Assistant refers to an unspecified amount of patients (ages and gender unknown).  The patients' medical histories, concurrent conditions and concomitant medication use were not provided.  On multiple unknown dates since 17-MAR-2017, an unspecified amount of patients were vaccinated with improperly stored VARIVAX (lot# M041513, expiration date 11-OCT-2018), (dose and route unknown) for prophylaxis.  Information regarding temperature excursion of vaccine; temperature and time frame:  47 degrees Fahrenheit to 77 degrees Fahrenheit for two hours.  There was no previous temperature excursion and data logger was not involved.  No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
1st DTP 06JUN90 resulted in fever to 102R x 3 days no other sx. 2nd DTP 10AUG90 resulted in immed fever.  28 hrs later, pt. developed gen sunburn-like rash which then converted to urticarial like lesions X 1 wk & temp 105 (R).
About 7 hours post booster, I started having pain in my left bicep where I received the shot. By 24 hours the pain spread to the lymph nodes in my chest on the left side. By the third day, the pain in my bicep subsided but the pain in my pectoral/lymph nodes in the chest remain. It hurts to the touch and when I tried to go for a jog, the jostling hurt too much to complete my workout. It?s now over 79 hours after the shot and it is still hurting about a 6/10 with 10 being the max pain.
I got my vaccine on a Tuesday, and I continued working through the day but that evening around 7:00/8:00 PM I became fatigued and sluggish. Throughout the night I felt miserable and I woke up Wednesday morning and had a fever of 103 and I had the chills badly, loss of appetite, upset stomach, headache, but the worst were the chills and the fever. I had the fever of 103 for 3 days. I was in bed for three days and couldn't break fever with Motrin or Tylenol, and it was just miserable. No appetite. I had a telehealth visit scheduled that Friday after the vaccine and so I met with Dr. and she said just to drink plenty of fluids and do what I was doing and If I wasn't any better by Monday to go see her in the office but I was much better.
it was noticed that the first syringe was empty.; it was noticed that the first syringe was empty.; This spontaneous report was received from the patient's mother referring to her daughter of a 13 years old female patient. Information about pertinent medical history, concurrent condition, concomitant medication and drug reaction/allergy was not provided.  On 29-AUG-2019, the patient came to receive her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis. On the same day, after the nurse stuck the patient, it was noticed that the first syringe was empty (product quality issue and circumstance or information capable of leading to medication error). The nurse got another syringe and administered second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of the event was unknown. The causality was not provided.
my injection was improperly given and not in the muscle; when she received the shot it was a "painful situation"; left shoulder discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: EW0150) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Caller reports that she received her first vaccine dose on March 17th (Lot - EN6207)), administration date: 17Mar2021, reaction(s): "COVID-19 Immunization". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as "my injection was improperly given and not in the muscle"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "when she received the shot it was a "painful situation""; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "left shoulder discomfort".  Additional information: Caller reports that she received her first vaccine dose on March 17th (Lot - EN6207) and her 2nd vaccine dose 3 weeks later on April 7th (LOT- EW0150). Caller reports having no concerns with her first vaccine dose but reports that when she received her 2nd dose, she noticed that the person administering the vaccine rubbed the alcohol really high on her left shoulder. The caller reports that she mentioned to her "That felt kind of high" and when she received the shot it was a "painful situation". Caller now states "I believe my injection was improperly given and not in the muscle". Caller reports that afterwards she has had continuous left shoulder discomfort and decreased range of motion stating "I can't bring my arm to the side without discomfort" but reports that the pain s starting to lessen. She asks, "Was my shot effective as it was administered?. She reports that she has given a lot of information already but had no reference number to indicate her filing a report. Agreeable to transfer to and wait time  (3 calls ahead). Provided number for reference. Caller also reports that she already reported to Vaers. Response received confirmed Pfizer covid vaccine. Spoke from attached documentation. Referred to HCP for evaluation and guidance. Transferred to queue to file a report with number.  No follow-up attempts are possible. No further information is expected.
Headache and chest pain started evening of receiving vaccine. Symptoms progressed over next couple of days. Diagnosed with myocarditis on 1/2/2022.
I realized after patient had left the store that I may have given him 0.6 ml of his Pfizer vaccine instead of 0.3ml.  I was unsure.  I have tried to reach patient  but his phone number says that his mailbox is full.  I called on 9/8/21 at 11:15 am and I also called on 9/13/21 at 4:38 pm.  I wanted to let the patient know that he possible got 0.6 ml.  I researched the information on this scenario, but I could not reach him.  The following is what I found out during my research: higher doses were given in trials, but it was decided to give 0.3 ml when the vaccine was released to the general population; people who received even the whole undiluted manufacturer vial were ok afterward; patients could possibly have more of the common reactions seen but are not in danger.
Having like heart palpitations and 'got over the cranny'; getting just like high blood pressure.; like you are going to get like anaphylaxis / he was relaxed as it just seemed like mental / it was like self-limitation, after the vaccine (COVID-19 Vaccine); This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Having like heart palpitations and 'got over the cranny'"; HYPERTENSION (non-serious), outcome "unknown", described as "getting just like high blood pressure."; FEELING ABNORMAL (non-serious), outcome "unknown", described as "like you are going to get like anaphylaxis / he was relaxed as it just seemed like mental / it was like self-limitation, after the vaccine (COVID-19 Vaccine)". Additional information: Patient reported that like his friend was telling him, like you are going to get like anaphylaxis or something. He went into his car and after, he was having like heart palpitations and 'got over the cranny'. But he was relaxed as it just seemed like mental and once you calm down then and he did not really have a reaction and that was not anaphylaxis. It was like constantly he was getting just high blood pressure. Also stated that it was like self-limitation, after the vaccine (COVID-19 Vaccine). The causality as reported by the physician: He did not believe/thought that his reaction was due to the COVID Vaccine (COVID-19 Vaccine).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She got her first dose of the vaccine on 3/21/2021. Two days later she noticed a sense of soreness at the right patellar tendon while riding her stationary bike. This lasted for 3-4 days and then she noticed the same issue with her right extensor tendons at the ankle. It then also presented on the last side in the knee and ankle. The right ankle was at one point quite swollen for a day or 2, and that is improving now but not fully resolved. No fever. No erythema. It tends only to bother her when the tendons are under load during physical movement. The more load the greater discomfort. It has not affected her hips or upper body at all.
On 11/14/21, I began to feel itchy all over my body, but particularly on my back, chest, feet, and hands. To determine the cause of this, I switched to a sensitive skin laundry detergent and systematically eliminated my soaps in the shower. I also tried moisturizing lotion and anti-itch cream. However, I was unable to find the cause or any relief. Around 2 weeks later, I began to experience hives in the same spots I was having the itching. I am unsure of the exact date, however the first time I took a photo of the hives was 12/1/21. My roommate was unaffected and I would get them no matter where I was (home vs school vs work). This made me determine that this was not caused by anything in my environment. The only way I was able to get any relief from the hives or itching was taking Benadryl. The itching/hives and Benadryl began to interfere with my daily functioning. I saw an allergist on 12/20/21. After an examination, he determined that I had excess mast cells in my skin which were releasing histamine, causing my hives. He demonstrated this through scratching my arm which immediately became red and raised. Fifteen minutes later, I developed hives on my neck/chest and opposite arm. It was at this time he postulated that this all was caused by my COVID booster shot which I received on 10/29/21, approximately 2 weeks before the itching began. He began me on an elimination diet, which consisted of no chocolate, nuts, alcohol, berries, or shellfish. I was also not allowed to take hot showers, was told to be gentle with my skin, and to take 1 Xyzal in the evening. After 2 weeks, he determined that the hives/itching were not caused by any food/drink but to continue with the Xyzal. At this time, I was not experiencing any hives/itching. The doctor told me on 2/7/22 to lessen my dosage to 1 pill every 2 days for 2 weeks and then 1 pill every 3 days for 2 weeks, then I wouldn?t take any at all. When I took the Xyzal every 2 days, the itching returned but it was tolerable. When I began taking it every 3 days, the itching began to interfere with my daily functioning once again. On 2/28/22, I was instructed to take the Xyzal every day once again to stop my itching and avoid the hives returning. This is where I am today.