chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up and I was freezing to death. My mind couldn't see pictures it was totally black. And I had a heck of a headache for 3 days now
administered  bexsero instead of menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th December 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th December 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Nurse reported that a 12 years old patient was administered Bexsero instead of Menveo, which led to wrong vaccine administered. No other detail available. The reporter consented to follow up.
Shingles outbreak; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was currently experiencing an outbreak of shingles between doses 1 and 2.
Pt was given vaccine in left upper arm. On 3/21/00 the pt experienced a local reaction 2 3/4 inches x 3 1/4 inches round that was red and painful to touch until 3/23/00. It was advised to ice the area and take Advil for pain and Benadryl. Pt is on Allegra during the day. Pt also on allergy injections (left arm) for grass allergy. Pt didn't receive injection this week.
Patient became lightheaded with blurred vision, pale, and nauseous within 5 minutes of administration of the vaccine. Called ambulence, EMT's performed vitals. Patient was given water to drink and refused transport to the hospital. Symptoms resolved between 30-45 minutes post vaccination.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender who in May 2013 was vaccinated with a first dose of GARDASIL, IM (dose, route and lot number not provided), in July 2013 was vaccinated with a second dose of GARDASIL, IM (dose, route and lot number not provided) and in September was vaccinated with a third dose of GARDASIL, IM (dose, route and lot number not provided). No adverse effects were reported. Additional information has been requested.
on 11/08, pt reported HR of 115 , BP of 150/80 and not able to sleep. advised pt to seek immediate medical attention. pt does not know her baseline. pt did confirm no problem on previous moderna vaccine before this adminstration. spikevax 50mcg/0.5ml Left deltoid, IM,
Her vaccination site scab fell off on 5/11/03.  Site bled on 5/13/2003 and pus accumulated at site.  Still has a pustule ~2 mm.  She was seen by an infectious disease MD, no redness, no itching.   Patient was wearing a waterproof bandaid as full time dressing as of 5/13/2003.  She was advised to switch to gauze with tegederm while at work, and gauze alone while away from work.
Patient was administered Vaxelis instead of Quadracel giving the patient an extra Hep B and HIB
Tenderness, pain, swelling of lymph nodes. Fatigue, headache, muscle pain, joint pain, chills, nausea and vomiting, and fever. Yup - I got 'em all.
Injection site pain with heat and stiffness within a couple hours of receiving the shot. I began to get fatigued around 9:00 pm and went to bed. Woke at 3:00 am with nausea, muscles aching all over my body, fever sweats and a terrible pain in my left arm. I tried to go back to sleep because I was extremely tired but couldn?t. I got out of bed at 6:00 am and felt dizzy upon standing. All throughout the day I continued to feel a pounding headache, nausea, fever, pain in my left arm, extreme fatigue, dizzy upon standing,. Later in the evening I noticed I had developed an itchy rash in 3 spots on my right arm. The next morning I woke up drenched in my clothes from sweating all night but felt much improved. The only remaining symptoms are injection site pain and the 3 rash spots on my right arm.
Patient received second dose of Pfizer vaccine 04/01/2021 and presented to office 04/19/2021 with report of left leg pain. Patient seen for repeat evaluation of leg pain after negative labs on 04/26/2021. Patient reported left leg popliteal pain as well as chronic leg cramps.
Asthma exacerbation; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: ek5730), via an unspecified route of administration at the left arm on 18Dec2020 13:00 at a single dose for COVID-19 immunization. Medical history includes adult onset asthma, seasonal allergies, anxiety and depression. The patient was not pregnant at the time of vaccination. Concomitant medication included atomoxetine hydrochloride (STRATTERA), vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol and levonorgestrel (SEASONIQUE). The patient experienced asthma exacerbation following vaccination that started 2 hours after (18Dec2020, 3PM) and worsened 1 day later. The pulmonologist advised to nebulize the patient with albuterol due to shortness of breath tightness and clear secretions despite MDI. The patient had to restart controller Symbicort (still with 3x day albuterol on 23Dec2020) and seen at an urgent care. Oral steroids were prescribed (Medrol dose pack). The patient was not hospitalized for the event but the resulted in Emergency room/department or urgent care visit. The event was reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient has been tested for Flu and COVID (Nasal Swab, PCR) Testing on 23Dec2020 and results were negative. The outcome of the event was recovering.
Baby expired 7 days after immunizations. No cause of death at this time. Case is being handled by Medical Examiner.  3/13/09 Autopsy report states COD as undetermined, associated w/co-sleeping in adult bed w/soft bedding.
Within seconds after vaccine was administered (2:20 pm) patient stated that her arm felt funny and that she couldn't see.  Patient stated that she wasn't feeling right.  Patient started to faint in the chair and was held up by nurse.  Patient began to turn gray/blue until nurse stated her name and grabbed her shoulders.  Color returned and with assistance from staff patient was laid on the floor. Color was pale.  Patient was alert and talking.  BP 92/54 P 84.  Patient stated that her lips felt numb; Benedryl 25 mg po given at 2:27 pm.  Patients hands were postured and she was unable to move them.  Ambulance arrived at 2:35 pm.  Oxygen was administered by paramedic and was taken to local emergency department.
Full dose instead of half of a dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE. At the time of the report, ACCIDENTAL OVERDOSE had resolved.      No relevant concomitant medications was reported. Treatment information was not provided.  The reporter also stated that they saw on TV a little boy got a full dose instead of half of a dose for the Moderna booster shot.
PATIENT DEVELOPED RASH ON THE ARM THAT HAS SPREAD TO THE BACK AND HEAD. RASH APPEARED AT 4PM 8/18/21. THE MOM GAVE THE PATIENT BENADRYL.  PATIENT ALSO FELT A SWOLLEN LYMPH NODE ON THE ARM WHERE THE DOSE WAS GIVEN.   NO OTHER SYMPTOM BUT RASHES AND SWOLLEN LYMPH NODE. THEY CALLED THE PEDIATRICIAN'S OFFICE BUT IT WAS ALREADY CLOSED AND THEY WERE ADVISED BY THE PERSON AT THE DR'S OFFICE TO GO TO THE PROVIDER THAT ADMINISTERED THE VACCINE. I TOLD THEM THERE'S REALLY NOTHING I COULD DO  SINCE I AM NOT A DOCTOR. BUT THEY JUST WANTED TO FIND OUT MORE ABOUT THIS SIDE EFFECT AND IF THEY SHOULD BE ALARMED ABOUT THIS. THEY DID NOT WANT TO GO TO THE URGENT CARE SINCE THERE ARE SO MANY PATIENTS THERE BECAUSE OF COVID SURGE.    I TOLD THEM I CAN CALL PFIZER AND THE DEPARTMENT OF HEALTH TO SEE IF I CAN GET MORE INFORMATION.  PFIZER SAID THAT RASH IS A POSSIBLE SIDE EFFECT TGAT CAN HAPPEN 1-2 DAYS AFTER VACCINATION AND THAT THEY CANNOT GIVE ANY MEDICAL ADVISE, AND THE PATIENT NEEDS TO CHECK WITH HIS DOCTOR. THE DEPARTMENT OF HEALTH SAID THE SAME THING AND TOLD THEM TO GO TO THE URGENT CARE.  SO I TOLD THE MOM TO JUST BRING HER SON TO THE URGENT CARE SO THAT SHE'LL HAVE A PEACE OF MIND.
She felt very sick for 2 days; Taste like metal; Fever; Headache; Muscle pain; Chills; Nausea; Felt like vomiting for 2days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She felt very sick for 2 days), DYSGEUSIA (Taste like metal), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (hospitalized in intensive care and received antibody therapy) on 20-Dec-2020. Concurrent medical conditions included Depression, Blood pressure management and Diabetes.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ILLNESS (She felt very sick for 2 days), DYSGEUSIA (Taste like metal), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Felt like vomiting for 2days). At the time of the report, ILLNESS (She felt very sick for 2 days), DYSGEUSIA (Taste like metal), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Felt like vomiting for 2days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken were  Blood pressure meds Diabetes meds Depression meds The patient stated she seen a pulmonologist No treatment medications were reported
On the night of day 6, I suddenly had incredible pain in my arm at the site of the vaccination, moving up into my shoulder and neck on the same side.  It subsided quickly, but then returned as I was sleeping.  I could not lie on my  opposite side either.  It passed by the next morning. Pain returned again on day 13, but this time the pain was agonizing, lasted two days, and seemed to be causing my right shoulder to spasm regularly.  Ice, Advil or Tylenol weren't helpful.  On day 28 the pain returned, my subscapular muscle spasm made my shoulder move, my heart rate went up, my blood pressure went WAY down, then became normal.  My D.O. said as it wasn't SIRVA, or another type of injury, it was likely connected to the vaccine  and that it might be helpful for researchers if I reported it here.     Incidental to this very challenging experience, in the weeks following my vaccination I also developed a strange water retention through out my body and experienced some fatigue, particularly after exertion, and sleep disruptions, and changes in bowel movement that were like symptoms I'd experienced the previous year, post a presumed case of Covid 19.   These issues continued even after the shoulder/neck muscular issue resolved.  Sometime in the early part of July I suddenly stopped having the water retention,  bowel issues, energy issues, or sleep disruptions too.   I now feel well again.  Note:   I am presumed to have had Covid last year, in the early to mid part of March 2020.  This was before tests were available, and before we understood that the symptoms I (and my husband) had were indicators of Covid 19.  I went on to experience symptoms that later we learned were "long haul" symptoms for approximately 6 months after my illness in March, clearing in December of that year.   I even had "covid toes" and developed Beau's lines in my toenails!   I think it may be possible that I had a strong reaction to the vaccine because I already had some antibodies from the previous year.   I am filing this as I hope having this information is helpful to someone.  I waited until now to file so that I could be sure I had no other reactions to record.
This spontaneous report received from a medical assistant referred to a 5 year old female patient. The patient had no medical history or concomitant medications. In past on an unknown date, she had taken VARICELLA vaccine. The patient was prescribed 1 dose of M-M-R II but received 1 dose of PROQUAD 0.5 ml subcutaneously (Lot number: M029595, expiry date: 10-DEC-2017) for prophylaxis instead on 21-OCT-2016. The medical assistant reports to her knowledge the patient has not had any adverse effects to the PROQUAD vaccine. Additional information has been requested.
Woke up with extreme chills, whole body was trembling, extreme fatigue, dizziness, felt like heart was beating fast, shaking badly to where it seemed like I could only take short breaths, headache, nausea, still cold after layering blankets, all of my joints ached. I stayed in bed and the symptoms subsided in about 2 hours. Later that morning and throughout the day I felt extremely tired, achy, difficulty concentrating or performing daily tasks- felt "foggy". Slept on and off during the day. Slept that night and felt a little better the following day. Still aching and sluggish but better. Following day I felt better. Today is 5 days later and I finally feel normal.
Dose administered after 2 days from manufacturer date of expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 2 days from manufacturer date of expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022 at 9:00 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Mar-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 2 days from manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 2 days from manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  On 25-Mar-2022, the patient received the booster dose of the vaccine.  On the day of visit at the clinic, the patient was not feeling sick. In the last 10 days, the patient did not undergo a COVID-19 test and did not have symptoms of COVID-19. The patient was not treated with antibody therapy or convalescent plasma for COVID-19 in the past 3 months. The patient did not have an allergic reaction to any vaccine, injection or shot or to any component of the COVID-19 vaccine or any severe allergic reaction to anything. The patient did not have a medical history of myocarditis, pericarditis, cancer, leukemia, HIV/Aids or any other condition that weakens the immune system. The patient neither takes medications that affect the patient's immune system nor had undergone any radiation treatments. The patient did not have a medical history of bleeding disorder, blood clots and was not taking a blood thinner. The patient had not received 2 doses of Pfizer vaccine or a previous dose of Jansenn vaccine or a previous dose of a non-FDA authorized or other WHO approved COVID-19 vaccine.   This case was linked to MOD-2022-530285 (Patient Link).
pt recvd 4th dose of vax;exp rash & itching;to MD on 19oct93;tx w/ lotrimin cream to rash prn,diflucan;rash & itching subsided in late february;
pt recv vax 1APR96 & 24JUN96 it was discovered that pt did not seroconvert (varicella-zoster IgG aB of .010);
Fatigue, muscle soreness in neck and shoulders, chills, burning sensation in eyes--generally flu-like symptoms; no fever; no congestion, no sore throat. Waxes and wanes. Slight flu-like symptoms off and on from 24 hours after vaccination, but primary onset at day 12 after vaccination. 2 days duration thus far.
On Feb. 22, late in the afternoon, patient received her third DTaP, polio and Heb B vaccine. Her mother gave her Tylenol. By 8 p.m. she became lethargic.  Her mother gave her Tylenol as recommended throughout the night.  Mother called the pediatrician around 7.25 a.m. to advise that her fever was at 103.5.  By 8:15 a.m on Sat. Feb. 23, she went into a seizure followed by a shock like state.  911 was called and she was taken to Hospital.  She is still sick with fussiness, seems to be achy in her back, sleepier more than normal, momentarily spaced out with eyes blank and open on 3/1/07, not eating solid foods, bowels irritated.  Physician referred her to a neurologist.
No adverse event occurred.  Advised by CDC phone contact to report vaccine given 2 yrs ago at another facility.  Vaccine given 2 yrs ago at another facility not registered on WV5115, not documented on school health record.  Discovered vaccine record brought from home after vaccine given.
Rash on injection site arm. Felt warm and firm and tender to the touch. Also itchy.  Resolved in 4 days
Body aches - 2 days Lower abdominal pain consistent with ovarian cysts - 4 days Early menstrual cycle Heavy bleeding and cramping during menstrual cycle
As PT was leaving she fainted in the front of the store as she was walking out. She fainted/fell into her mother's arms and fell to the floor. When she hit her head. Upon notification, she was attended to and after several minutes, she was able to get up and walk out. At the time of incident, she was asked if she would like us to call for an ambulance - she declined. After leaving about 20 minutes later the mother phoned to say the PT was nauseous and her head hurt and they were going to the hospital.
BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple 6 female patients. 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 were not reported), frequency once total, 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 consumer stated that 6 patients experienced blood clots from the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210526046-Covid 19 vaccine- blood clots. This event is considered unassessable. The event 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.
tingling lips, swollen tongue 8 minutes after vaccine given. Was given 25mg PO benadryl  At 2:25pm tingling stopped, tongue is better but wasn't back to baseline.  2:35 pm felt fine and husband took her home.
PT had severe flu like symptoms for 3 days post injection. Pt had sore arm starting after injection, expected it to go away after 3 days but it still remains after nearing 30 days. Pt says hurts to lift arm above shoulders. Has not seen MD since incident.
Breastfeeding; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and was breastfeeding/maternal exposure during breast feeding .  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 22 Dec 2020, the same day as the onset of the event, the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.   The patient was breastfeeding at the time she received her first dose of mRNA-1273.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event breastfeeding was recovered.  Reporter causality for the event was not provided.
Two weeks after moving into new home I had to have eye surgery because of loss of vision in one eye.  Surgery in November.  At the end of December close to Christmas, 3 weeks after vaccine, I started having pain in my right foot.  The pain is heal pain, fasciitis.  The pain continued to become more severe and I was unable to walk.  I got my second vaccine in January.  Pain in foot still severe.   I went to see the podiatrist.  I was also having pain in the middle toe of my left foot.  I was diagnosed with plantar fasciitis and a heal spur in my right foot.  After several types of steroids and shock wave treatment I am still hobbling around from one room to the next.   My next appointment with podiatrist is July 18, 2022.
C/o severe headache on the following morning woke up with headache which lasted 4 - 5 hrs. Took 2 TYLENOL tablets. Painful and tender left arm which lasted 3 days.
Swelling of tongue, lips, and chin.  Next morning very dizzy could not walk and had a headache.
Patient reported rash at the injection site with pain that radiated down his arm to his fingers, lower back pain, and knee pain. Additionally reported a headache, and red bumps on the back of his left leg. This occurred around 7 pm the night of the vaccination and resolved within 5 days. He did not seek medical care in the time period, but considered going to the emergency room if the symptoms got worse.
development of severe neck pain leading to acute quadriplegia over the course of 24 hours Patient was intubated, started on high dose steroids and had an emergent C3-C7 decompressive laminectomy, medial facetectomy Extubated in ICU and now recovering.
After administering Tdap vaccine the patient fainted. TR, BP, WNL. Water given. Was all better <1 minute.
Extreme tenderness in area of flu shot; soreness & tenderness & later sweling by 11JAN92 arm mobility way down & discomfort very high; pt went to MD then referred to specialist 29JAN92 w/same sx as 11JAN92 & in between; tedonitis;
Pt given shot at another office with PCP-and come into our office for 2nd BEXSERO shot and stated Left arm where BEXSERO #4 was given became site became red swollen x 2 days.