chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have itching problem on my body after the vaccination shot. It started 5 days after the shot and still didnt stop.; This is a spontaneous report received from a contactable consumer. A 39-years old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration in right arm on 14-MAR-2021 14:00 at single dose for COVID-19 immunisation. It was reported that the patient was Unable to locate or read the details. Medical history and concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine neither was tested for COVID. On 18 Mar 2021 12:00 PM, after 5 days of shot the patient had experienced itching problem on body after the vaccination shot. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient had not recovered from the event.
This spontaneous report as received from an office manager via a company representative refers to a 60 year old male patient. Medical history and drug reactions/allergies were not reported. On an unspecified date in April 2013, the patient was vaccinated with ZOSTAVAX (lot, dose and route not reported). Concomitant medication was not reported. On 14-FEB-2014, the patient experienced itchiness, rash and pain. On 14-FEB-2014, the patient visited an unspecified physician's office. The patient was prescribed pain medication (unspecified name, dose/frequency and manufacturer), and cream (unspecified name, dose/frequency and manufacturer) for the itchiness. The outcome of itchiness, rash and pain was not reported. Additional information has been requested.
Given dose of Trumenba on 9/3/2019, client had already received dose of Bexsero on 07/15/2019. inadvertently gave wrong Men B product which are not interchangeable
Pt is about 10-12 weeks post partum. Breast fed exclusively. Reports still having vaginal bleeding post delivery. Hx of palpitations triggered by anxiety. Last episode was "several years ago". Used to take propanolol for control (not currently). Palpitations were treated with rest and propanolol. No other known medical conditions or medications.  Denies any cardio/pulm/endocrine issues.   Five minutes post vaccination with dose #1, she started to feel "chest discomfort like sharp, localized discomfort (not pain) on left upper chest. They occurred every 3 min and lasted about 40 seconds.   After 20 min observation, she reports that she "feels better". Palpitations occurred every 3-5 mins but lasted less than 20 seconds. Pt also c/o nausea.  vitals @12:30 BP 121/71, HR 70, RR 14, SpO2 100% -- > @12:40 117/68, 66,14, 100%, Temp 98.2 -- > @12:45 120/66, 66, 14, 100%, 98.2 -- > @12:55 111/65, 66, 14, 100%, 98.2 -- > @13:00 110/65, 66, 14, 100%, 98.2 -- >@13:03 108/63, 63, 14, 98.2 -- > 13:12 119/68, 100%   Denies SOB, CP, HA, or dizziness. Pt given water and laid down on cot.  Pt speaking in full sentences and sipping water.  Patient stable, released from vaccination site. Patient was discharged at 13:15. Reports she "feels better". Palpitations have improved significantly. ?Recommended patient follow up with their healthcare provider. Follow up instructions provided. Go to Urgent Care if palpitations worsening or new sx such as dizziness, HA, or syncope.  FU with pcp if sx persists after 72 hours.   Patient agreed and verbalized understanding. Husband drove her home.
Flu like symptoms. Very exhausted. Achy body and bones. Sore muscles all over. Tired and slow to think. Chills, nausea and a severe splitting headache.
Hives that would spread throughout the body at the slightest irritation, even clothes would trigger hives. The hives were mostly located on my lower arms and thighs, but would spread to my chest and back.  This last over 3 months, during those 3 months the hives would disappear for a day before coming back. About a month into the hives showing up, they started to spread to my face and lip area, which is when I contacted the doctors. A blood test showed that I was having a slight allergic reaction but nothing else was different. I was prescribed Cetirizine, and it worked at first but the hives still showed up while taking it, and sometimes seemed even worse than if I wasn't taking the medication. A few weeks after taking the medication , the hives disappeared.
3/30/21-Left arm site really sore about 15 minutes after shot! This morning 3/31/21 got up went to work had slight head ache, as day went on, it got worse, called pharmacy lady said to take Tylenol took at 10 Am. After that I started getting chills, was feeling sluggish, weak still had headache so my Boss, told me to finish up work and go home for day! I left at 2pm and lost time at work due to vaccination and $$$. Came home went to bed and got up twice to go to restroom. Running fever of 101.5, Took 2 more Tylenol?s and in bed as I email this! Night I hope to get up better in the AM. How long does this last! I did not get to enjoy Christmas I had Covid week of Christmas, and now Easter this weekend! Not feeling good and not HAPPY to be ill!!!
Few hours post-vax developed headache. Took  Tylenol. Went to bed, no symptoms. Woke up with cough and experienced headache and fatigue throughout the day. Seen by NP at Employee Health, below tests performed. Symptoms persisted through 12/18. By 12/19 symptoms resolved.
My wife has been sleeping constantly since getting the booster dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (My wife has been sleeping constantly since getting the booster dose of the Moderna COVID-19 vaccine.) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 012120A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia. Concomitant products included SIMVASTATIN and MEMANTINE for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (My wife has been sleeping constantly since getting the booster dose of the Moderna COVID-19 vaccine.). At the time of the report, SOMNOLENCE (My wife has been sleeping constantly since getting the booster dose of the Moderna COVID-19 vaccine.) had not resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No treatment reported.
Eve of vaccine, only arm soreness, shoulder and neck stiffness. Day after vaccine on 4/7, more severe muscle soreness/stiffness, headache, heartburn and a raised, red, not really itchy rash appeared around 7pm covering my entire abdomen. Today, 4/8/21, the rash was pinpoint red on my abdomen but now large, raised and patchy on my chest. I mostly just wanted to report the rash since it was so delayed and I wasn't expecting this. The other symptoms I  was expecting.
Got a fever and chills which seemed expected on Sunday  evening the day after the shot on 3/6/21. On Monday, I was fine but tired and went to bed about 11PM. I awoke to the feeling that the room was spinning even with my eyes closed and when I opened my eyes the room continued to spin around me. I could barely stand up when I tried. Felt nauseated but did not vomit. The vertigo continued off and on on Tuesday, Wednesday, and Thursday especially when I would lay flat either on my back or stomach if I turned my head. I went to my doctor this morning who ruled out an ear infection or wax build up. She encouraged me to contact her if it continued after a week. I have only had vertigo two times in my life, both after a physical trauma to my head (car accident when I as 30, and surprise tackle during touch football) when I was 53. This struck me as an unusual side effect  from the vaccine since I have never had vertigo without a prior event like an accident.  I am in good health otherwise.
On April 1, 2022 - I got the Booster.  Only now - on May 2nd - does it not look like I have a bruise at the injection site.  A bruise is one thing - which I expected to fade after a couple of days and be totally gone in a week.    I may be out of shape but otherwise in good health.  I am reporting this - as anonymously as possible - because a bruise lasting for 4 weeks is not what I would consider "normal".
Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277419 and 2018SA277418 (same reporter). This case involves a female patient (age unknown) who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a single 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine (lot number: UT6301NA and expiry date: 30-Jun-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to vaccine underdose. It was reported that 3 of the 0.5 ml prefilled syringes leaked around the hub during administration. Two different nurses found that when they were going to give vaccine with needle already attached, it leaked from base of the hub with 3 different prefilled syringes and were unable to deliver full dose (syringe issue). It was unknown whether product technical complaint was registered or not for the syringes. It was unknown if 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. List of documents held by sender: none.
06.07.12 - MMR given. 06.14.12 - rash, irritability, poor eating, fever. 06.15.12 - recovered. 6.20.12 rash irritability still with symptoms.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 23-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: ew0177) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21May2021, outcome "recovered" (2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine was administered in four weeks. Post vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
BODY ACHES; ARM SORENESS; HEADACHE; HIGH BLOOD PRESSURE; NASAL CONGESTION; This spontaneous report received from a patient concerned a 50 year old female. 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 not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced high blood pressure. On APR-2021, the subject experienced nasal congestion. On APR-2021, the subject experienced headache. Laboratory data included: Blood pressure (NR: not provided) 130/85 mmHg, 160/100 mmHg.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced arm soreness. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) 145/95 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and arm soreness on 08-APR-2021, and had not recovered from high blood pressure, headache, and nasal congestion. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as per standard operating procedures, as the case was assessed as non-serious.
I got the vaccine Wednesday at 3pm. Around 7pm I started having chest aches/felt like my heart was fluttering. The next afternoon I broke into a sweat, got light headed, and my chest started aching. The sweat broke and I felt a bit better. Each morning and evening my chest was feeling like it was throbbing/aching/fluttering (no sharp pains, more so aches). Friday I went for a run (I run 4-5x a week without any issue) and it felt like my heart was going to pound out of my chest so I walked. As the days have went on, the ache has been more consistent a few times a day for 1-3 hours at a time. The last few days I had about 3-4 sharp pains and got lightheaded twice and have felt fatigued, weak, and clammy. I called the pharmacy Thursday 8-12 and they said I need to visit doctor to rule out heart inflammation. Hospital was booked/refused to make time for me so I went to the urgent care which was a 3 1/2 hour wait. So I made an appointment at urgent care friday 8/13 at 9:15am and they did an EKG. It read normal results, but I was told I could have some inflammation in the chest area that EKG didn't pick up or it was in early stage that wasn't detected by machine. It's very scary and frustrating considering I am a very healthy person (work out 6 days a week and eat healthy) and have never had heart pains/issues. The timing directly coincides from when I received the vaccine. They prescribed anti-inflammatory medication for me to pick up today and be on for 2 weeks to see if it gets rid of the aches/pains.
Shingles-like rash on left side of torso. Itchy and painful. Taking ibuprofen
Chills, High fever, 101 measured by Patient.  Rash on chest for 3 days.
Patient reported an injection site reaction involving itching, swelling and redness about the size of a silver dollar starting 2 days after the injection. These symptoms resolved in a few days after they appeared. No treatment was required.
Information has been received from a nurse practitioner concerning a 9-10 year old patient who was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed a very severe local reaction to the vaccine. Unspecified medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Infant received ROTATEQ 2nd dose on 6/1/07; on 6/17/07diagnosed and operated on for intussusception in hospital.  8/3/07 Received vax record which provided RO lot # 1365F & dose #2.  Prevnar Lot # should be B08690C.  Database updated w/same.  8/28/07 Received hospital medical records from CDC which reveal patient experienced vomiting & bloody stool x 1 day. Admitted 6/17-6/19/07.  BE diagnosed IS but unable to reduce.  To OR for reduction of ileocolic IS & appendectomy. Progressed well post op. FINAL DX: Ileocolic IS, surgical reduction.
After receiving vaccine began to feel dizzy and lightheaded and sat in observation area  and developed a diffused urticarial rash and was sent to ED.  She also C/O of difficulty swallowing.  Erythema B/L cheeks, Rash diffused B?L chest and behind left ear  Patient given Benadryl 25 mg IV at 11:15, Pepcid 20 mg IV given  11:15, SOLU-MEDROL 125 given at 11:30  13:20 feeling much better and has fontal headache discharged home at 14:20
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with RECOMBIVAX (lot # reported as N002922, expiry date: 30-SEP-2018) (route: intramuscular), that was improperly stored (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F (34.8F) for 1 hour and 15 minutes, at 32°F to 35°F (35.4F) for 4 hours and 24 minutes, at 32°F to 35°F (35.4F) for 4 hours and 12 minutes, at 32°F to 35°F (35F) for 4 hours and 36 minutes, at 32°F to 35°F (35F) for 4 hours and 18 minutes, at 32°F to 35°F (35F) for 4 hours and 42 minutes, at 32°F to 35°F (35.4F) for 2 hours and 30 minutes, at 32°F to 35°F (35.4F) for 3 hours and 18 minutes, at 32°F to 35°F (35.2F) for 4 hours and 54 minutes, at 32°F to 35°F (35.2F) for 4 hours and 42 minutes, at 32°F to 35°F (35.2F) for 4 hours, at 32°F to 35°F (35.4F) for 2 hours and 24 minutes, at 32°F to 35°F (35.4F) for 2 hours, at 32°F to 35°F (35F) for 4 hours and 6 minutes, at 32°F to 35°F (35F) for 5 hours and 24 minutes, at 32°F to 35°F (35.2F) for 5 hours and 6 minutes, at 32°F to 35°F (35.2F) for 5 hours and 18 minutes, at 32°F to 35°F (35.4F) for 3 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse symptoms reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA011419: US-009507513-1707USA011601: US-009507513-1707USA011607: US-009507513-1707USA011615:
Took Benadryl by mouth prior to vaccination (had a reaction last year to flu shot). Had some mild wheezing.  Experienced body aches, stiffness and pain in body.  Injection site looked red and swollen, also had itching,  looked like a baseball was in arm.  Felt like she had "frozen" shoulder.  Came to clinic 11/01/22 to see NP.  She was very anxious. Felt like having shortness of breath also.  On 11/3, redness was increasing and spreading- came back to clinic.   Taking PEPCID and Benadryl.  On 11/5 saw MD. - states very swollen still and tender to touch. States some numbness/tingling  in thumb, ring finger - goes to sleep faster.   Rx's for:  Allegra 180mg tid x 10 days; Pepcid 20mg x 10 days.  Is getting better.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 2 year old patient. On 12-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Left thigh contusion. No erythema. Rx: warm compress, supportive care.
On May 13,20231 I had a stroke  The Neurologist told me it was a 1.4mm clot with no hemorrhaging
5 minutes after vaccine given, she stood up and said "I feel sick" and collapsed, was unconscious for 30 seconds. VS were WNL, was weak, fearful, had some tightening of arms and legs in unnatural positions briefly. EMS took her to ER.
The date on the vaccination card is 2/5/22, not 2/9/22 as previously stated.  I started having fever by 9pm and was in bed unable to get up except to toilet for 24 hours, then nauseous for 24 hours then the coughing and wheezing started. I have been coughing and wheezing for 11 months.  I have been to 2 different providers at a local minute clinic who refused to treat me and my primary care refused to treat me.  I did  not pursue the pulmonologist., but it has been difficult to sleep at times because the wheezing keeps me awake.  I have taken guafenisen otc and it has helped a little,  An NP from another location prescribed a steroid pack which helped while I was on it but symptoms returned when it was completed.
projectile vomiting occurred only one time 11 hours post vaccine administration. no other signs or symptoms.
Pt. reported that on the 25th of September, she received a Pneumo and flu immunization. Pt. described the procedure as "rough." She reports when her left arm was injected, she immediately felt excruciating pain to the point that she reports she "yelled out."  She reports later that same day the pain increased in intensity and when she attempted to move her left arm, a sharp, grabbing pain shot down her arm and into her left hand causing tingling in the fingers of the left hand. Upon examination, (she still has the bandaid on,) the injection was given approximately 3cm below the acromion process, which in my opinion, the injection was given to high. Pt presents with the classic symptoms of SIRVA. Provider ordered a xray to start and started her on medication. I ensured her I would speak with Medical Director in the morning and update him and work with him to formulate a plan of care. She was very understanding (retired nurse,) and reports that she understands that mistakes are made, she voiced she just doesn't want anyone else to go through this.
skin rash developped 4-5 days after vaccination. asymptomatic oval shaped pink papules with colarette of scale and some with central necrosis. skin biopsy diagnosed as Pityriasis Lichenoides et varieliformis Acuta: PLEVA
pt recv vax 26MAY95 & devel large, raised area @ inj site & redness, itching & burning @ inj site; No further details were provided;
Patient states her arm was very swollen and warm after the vaccine. It is almost a month later and she states the injection site is still tender to the touch.
Erythemic welt at injection site which was itchy. Patient also reported feeling itchy inside. Patient has been taking diphenhydramine with gradual relief prior to ED presentation on 10/15/10, 3 days following influenza injection. Influenza injection given outside of clinic. No specific information available.
Rash on lt arm from shoulder to elbow-hot to touch, started running fever to 103; mom ice packed arm & gave APAP;
Case number PHEH2016US030405, is a report initially received from a nurse on 17 Nov 2016. This report refers to a 37-years-old patient. Past medical history and concomitant medications were not reported. The patient inadvertently vaccinated with FLUVIRIN (batch number: 1620201) on 10 Nov 2016. On the same day a nurse found that FLUVIRIN vial was leaking and some of the vaccine got on her hand. She washed her hands at the time. No problems or symptoms occurred. No adverse event was reported following this administration error. Batch review report reference number [1017976] received from quality assurance department on 05 Jan 2017. Based on the document review, it was stated that the concerned FLUVIRIN batch number [1620201] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from Quality assurance department of 05 Jan 2017: Added QA reference number (1017976) and  investigation summary.