chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose of DAPTACEL given at 18 months of age with no reported adverse event; Initial information received on 06-Mar-2023 regarding an unsolicited valid  non-serious case received from a mother of patient.  This case involves a 1 years old male patient who had first dose of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel]  given at 18 months of age with no reported adverse event.   The patient's past medical history included Heart murmur and Neutropenia. The patient's family history included risk for seizures. The patient's past medical treatment(s), vaccination(s) was not provided.   On 08-Feb-2023, the patient received 0.5ml dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for Immunization.   On 08-Feb-2023 the patient developed a non-serious event of first dose of daptacel given at 18 months of age with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day). It was due to health issues that pat8ent had in first year of life. Reporter was asking safety and efficacy of Daptacel in patients that have taken their doses later than what was recommended in the Prescribing Information. Reporter asked what was done for babies that have cancer and cannot take their Daptacel during the recommended age windows. Reporter was very concerned that something may happen to her child because he received his first dose of Daptacel outside of the age recommendations of the Prescribing information and would like to speak with someone additionally regarding this situation.  Action taken : not applicable.  Outcome: Unknown  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 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.
Pt presented to hospital via ambulance with cardiac arrest after a CC of SOB.  Pts sister who spoke with her two days ago stated she was in normal state of health and just got her 2nd dose of the covid vaccine.  Unknown which manufacturer.
After getting my shingles vax I got a really red itchy neck that I couldn't stop scratching and caused misery. I eventally went back to the doctors and was told to take Telfast 180 and put on my Dovebet steriod cream. After two weeks it went away. Yesterday July 14th it came back but not so severe. I just took a Telfast 180 and put on the ointment.
Very slow weight gain in infant over the next 5 months. Infant gained 2 lbs 5 oz over the course of 5 months after vaccination: +1 mo: +13 oz, +2 mo: +2 oz, +3 mo: +3 oz, +4 mo: +8 oz, +5 mo: +11 oz.
This spontaneous report as received from a physician refers to a patient of unknown age. On 03-JUL-2012 the patient was vaccinated IM with a 0.5 ml dose of GARDASIL which was exposed to temperatures that they could not support. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Right sided neck pain, Lump in throat, pain in back of neck, shortness of breath
Headache, fever, dizzy, stiff neck, loss of smell/taste.   Recovered smell/taste last week, low grade fever also resolved about the same time. The headache and neck stiffness remain.
As the needle was being inserted and while the vaccine was being injected, I immediately felt intense pain like none I've had during any prior vaccine administration . The needle was inserted very high on the arm about 1/2 inch below the shoulder.  About 4:00 pm that afternoon, new pain developed in the same shoulder, along with very limited range of motion, gradually worsening during next few hours. By 9:00pm the pain was excruciating, like there were multiple knives in all directions in my shoulder. By then I could not lift or move my arm any amount in any direction without excruciating pain.  I suspected a severe inflammatory response. This pain level continued for the next 2 days.  On the 3rd day the pain was a little less severe and I had slightly more range of motion, but was still unable to lift my arm without pain. On the 4th day (Feb. 18) the pain was a little better but I still had severe sharp pain if I lifted my arm in certain directions. I began to suspect a torn muscle or tendon. Today (March 5, almost 3 weeks after the vaccine), the pain and limited range of motion are the same as Feb. 18.  It is relieved only by complete rest of the arm, and easily aggravated by any basic activity (grocery shopping, dressing, etc.)  I believe my shoulder was injured by improper administration.
pt recv vax 4DEC97 & 9DEC97 pt devel a hive like rash in patches w/wheals & vesicles greater than 100;
Pt's mother called on the morning of 9/12/01 and described a warm and swollen left arm. Instructed her to continue with Tylenol every 4 hours and cold compresses until the afternoon then use heat. Mom brought child into clinic on the morning of 9/13/01 with left upper arm swollen, red and slight amount of clear "weeping" from arm. Child appeared fine, otherwise. Instructed use of ibuprofen for anti-inflammatory effect. Admitted to the hospital with cellulitis.
Information has been received from a nurse practitioner through a Merck pregnancy registry concerning a 24 year old female with a history of 3 live births prior to vaccination of GARDASIL, who in February 2007 (according to the patient) was vaccinated with the first dose of GARDASIL (lot number, route and injection site unknown) at a different facility, when she was 5 weeks pregnant. The patient had sought unspecified medical attention. On an unknown date she terminated her pregnancy. Subsequently, during 2007 the same patient became pregnant 3 more times and each pregnancy ended with spontaneous abortions (miscarriages) (WAES # 0811USA00647, WAES # 0811USA00648 and WAES # 0811USA00649). The patient became pregnant again and gave birth to a child in September 2008 (WAES # 0811USA00650). On 30-OCT-2008, the patient received the second dose of GARDASIL (lot number, route and injection site unknown). Upon internal review, elective abortion was considered to be other important medical event. Additional information has been requested.
Sweats; Chills; Vomiting; Headache; Generally feel like crap; This non-serious case was reported by a consumer and described the occurrence of sweating in a 68-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included lisinopril and sildenafil citrate (Viagra).   On 04-OCT-2023, the patient received Shingles vaccine. On 04-OCT-2023, less than a day after receiving Shingles vaccine, the patient experienced sweating (Verbatim: Sweats), chills (Verbatim: Chills), vomiting (Verbatim: Vomiting), headache (Verbatim: Headache) and feeling abnormal (Verbatim: Generally feel like crap). The outcome of the sweating, chills, vomiting, headache and feeling abnormal were not resolved.   It was unknown if the reporter considered the sweating, chills, vomiting, headache and feeling abnormal to be related to Shingles vaccine.  It was unknown if the company considered the sweating, chills, vomiting, headache and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 6-OCT-2023 The reporter after receiving shingles vaccine experienced sweats, chills, vomiting, headache and generally felt like crap for the last two days since he got the shot. The symptoms were not treated. The reporter consented to follow up.
no additional Aes; vaccine administered after temperature excursion/Temperature 48.9F; This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-SEP-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated( VAQTA) injection in prefilled syringe, lot # T035720, expiration date: 15-APR-2022 (also reported as 4815/2022) (exact dose, injection site and route of administration were not provided) for prophylaxis.  On an unknown date, the administered dose experienced a temperature excursion of 48.9 degrees Fahrenheit for 30 minutes. No previous temperature excursion had occurred. No additional adverse events were reported.
10 minutes in Heart Rate elevate 125 and  99 oxygen  201/90 blood pressure
got the shots..but didn't work cause I still get it/suspected vaccination failure; I still get it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-Sept-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shots but did not work, he/she still got them. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Arm swollen from shoulder to below elbow. Fever in arm, painful and sore to touch. I felt sick for two days after shot.
7/24/21: Patient admitted to hospital for fevers, weakness, poor PO intake.  Patient was exposed to COVID-19 recently and tested positive on admission. Note, patient has previously received the COVID-19 J&J Vaccine on 4/1/2021.   Diagnosed with: bibasilar pneumonia due to COVID-19 infection. 7/27/21: discharged.
Left arm erythema, swelling, pain. 4x3cm area. Benadryl given and Keflex.
I needed a tetanus shot for an infection, and received the tdap. I experienced a sort coughing spell within 10 hours, mild cold symptoms the next morning, a sore arm for several days, redness and swelling at the site of injection and tiredness. I received the shot 4 days ago. I suggest that tetanus shots alone be recommended by CDC for people who have allergies to other medicines and are looking for protection for the one item. Thank you.
feeling light head; coughing; This is a spontaneous report from a contactable consumer (patient's father) reported for his son (patient) that a male patient of an unknown age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. Patient experienced feeling light head and coughing on an unknown date. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
AFTER RECEIVING THIS DOSE SHE FELT ANXIOUS. ON SITE EMS RESPONDED. VITALS LISTED BELOW. SHE WAS MONITORED, AND FELT BETTER. SHE WAS RELEASED TO HOME
The patient already has 2 antibody productions, shouldn't need more to provide more for a period of time after initial vaccine and acute illness; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COVID 19 Vaccine, mRNA-Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "The patient already has 2 antibody productions, shouldn't need more to provide more for a period of time after initial vaccine and acute illness". Additional information: Pharmacist, from withheld, calling for guidance on when the vaccine should be given to a patient following an active infection. He states he has seen both dose 1 and 2 information that "we need to defer 90 days if someone has received immunotherapy" but he has not been able to find information about a patient who received dose one of the vaccination and in between dose one and 2 contracted COVID 19. Caller would like to know how long to defer the patient before providing the 2nd dose of the vaccine. Advised caller per attached document with disclaimers; People with prior or current SARS-CoV-2 infection "People should be offered vaccination regardless of their history of symptomatic or asymptomatic SARS-CoV-2 infection; this includes people with prolonged post-COVID-19 symptoms. Vaccination of people with known current SARS-CoV-2 infection should be deferred until the person has recovered from the acute illness (if the person had symptoms) and they have met criteria to discontinue isolation. While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the months after initial infection but may increase with time due to waning immunity. Thus, people with a history of MIS-C or MIS-A should consider delaying vaccination until they have recovered from their illness and for 90 days after the date of diagnosis of MIS-C or MIS-A. Caller requests information "off the record" stating "shouldn't we defer, its counter intuitive. The patient already has 2 antibody productions, shouldn't need more to provide more for a period of time after initial vaccine and acute illness. You can extend the antibody production and protection for later if the vaccination is deferred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   Follow-up (11Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
I received 2nd Covid 19 vaccine on April 9th 20201 at 6pm PT.  Then I started to have lower back pain on Saturday (April 10), but I was still mobile,  and was able to perform daily activities.  However, on Sunday morning (April 11th), my lower back pain became better, but I started having very severe pain on my left thigh.  The pain scale is 10 out 10, and I was unable to move around.  I could feel the muscles around the nerve were twitching and cramping, and this gave me such an excruciating pain, and felt like the nerve was squeezed by the thigh muscles.  Because of this severe pain, I was not able to mobilize at all on Sunday, then had to go see physician on Monday urgently.  The physician was puzzled why I devel
Patient received vaccine on Friday morning (11/3/23) at pharmacy, Saturday morning (11/4/23) patient was sweating profusely and had chest pain. She went to the ER and was admitted for 4 days for supraventricular tachycardia, cardiac catheterization was done on patient and no heart damage found, patient was finally stable and was able to leave the hospital after 4 days.
Pt recvd vax & devel local arm swelling, lip swelling, facial swelling, generalized pruritus, generalized hives, wheezing & bronchorrhea;
Patient reported balding spot left temple within one week of receiving first COVID shot 9/20/2021. The balding area left temple continued to increase in size. He received the 2nd COVID shot 10/14/2021 and continued to see more bald spots various places on his scalp.   First medical encounter patient sought was 11/19/2021. He was treated with betamethasone dipropionate daily to the affected areas.
I tested positive for Covid on 5/8/2022. On 5/5/22, I became very congested. My symptoms continued to get worse. I woke up at 2:30AM and took my temperature and had a low grade fever and took some ibuprofen. I tested positive the next day.
STARTED HAVING ACID REFLUX A COUPLE OF NIGHTS AFTER RECEIVING THE INJECTION. WOKE UP A FEW TIMES EACH NIGHT AND TOOK TUMS, WHICH RESOLVED THE INDEGESTION. I HAVE NEVER HAD GERD BEFORE, EXCEPT WITH 20+ WEEKS OF PREGNANCY. THE FOLLOWING MONDAY, I HAD CHEST PAIN,  SHORTNESS OF BREATH THAT WORSENED WITH TIME. THE EMERGENCY DEPARTMENT R/O PULMONARY EMBOLI, OR AN ADVERSE CARDIAC EVENT. THE PHYSICIAN CHALKED IT UP TO ANXIETY, WHICH IT WAS MOST DEFINATELY NOT. RIGHT BEFORE DISCHARGE HOME, I GOT REALLY NAUSEATED AND THREW UP, WHICH COMPLETELY RELIEVED THE CHEST PAIN. THE GERD CONTINUED UNTIL I WAS ABLE TO SEE MY PCP, WHO PLACED ME ON OMEPERZOLE QAM. I HAVE BEEN ON IT SINCE. WHEN I SKIP A DOSE, THE GERD RETURNS.
Severe headache, muscle spasms in lower back, weakness in legs, running nose combined with congestion.  Soreness particularly in the arm in which the dose was administered, beginning the following day.
About 30 sec after dose administered, pt said he did not feel well, and then fainted. Ammonia inhalent brought patient back around. Oxygen given and pt stabilized.
Blood in blood x 1 day (bright red blood). This happened 24 hours after the shot. Leg swelled up and got a hard lump.
Return of sarcoidosis sign & symptoms. 1. Skin rash lower legs and feet, Had not had rash since Feb 2011. 2. Back pain in area of mediastinal lymph nodes. Had not had pain since Mar-Apr 2011.
Pt developed soreness in arm, agitation and anxiety attack within hours of shot. Pt otherwise calm and relaxed. Pt stated he felt "weird."
Fever (100.9), Nausea/Vomiting, Sever headache, Chills, Diarrhea.
12:42 Patient received 2nd Moderna vaccination. 12:52 Patient reports tongue tingling and swelling. 100 BPM, BP 150/90, 98% RA, R 18. Normal sinus rhythm with intermittent PVCs. 12:54 patient took own additional 25 mg Benadryl, 10 mg Claritin and Xopenex inhaler. Patient denies shortness of breath, patient speaks in full sentences, no neuro deficits. Patient denies chest pain, difficulty swallowing, N/V, itching or hives. Reports dizziness. Patient tachycardic, pulses strong and equal bilaterally, lungs CTA w/o wheezing, rhonchi or stridor. Alert and oriented x3. Call to patient?s doctor, Dr. advised patient to go to ER. Patient agrees to transport to ER. 13:27 EMS left with patient to ER. Patient?s previous VAERS report completed from 1st vaccination.
Rectal Bleeding or Hemeroid rupture.  No treatment as of day 2.  Ongoing , wait and see what happens next.
Redness at the site of injection, warm to the touch, somewhate painful. He also has low grade fever which was resolved after taking Advil.
I began with tingling and numbness on my entire left side of the body.  It began a few days after the vaccine and I reported it to my doctor after a few days.  He thought it may be  and ordered a scan of my brain and neck (which was negative).   After reading a blog with a few hundred people reporting the same symptoms after receiving the vaccine (COVID-19), we decided to revisit the illness about 6 weeks later if the symptoms had not gone away (as most were reporting in the blog - no treatments worked, just 5-6 weeks and it went away).  It has been 6 weeks and I am following up tomorrow with my doctor.  The symptoms are worse than ever.  Numbness and burning continue along my entire left side.  A little painful and extremely annoying with the sensation of feeling swollen across my entire left side.  No medications taken to remedy as of yet.
fever to 102; rash upper torso; MD rx APAP & cont to monitor; MD felt it was an adverse reaction due to the rash occurring 1 day p/immun;
The following is based on report from, Paramedic, (date of birth: 04/09/1993) received the 1st COVID vaccine (Pfizer, Lot #: ER8735 and expiration date: 07/31/2021) at 1309 on the left arm. Medic made contact with patient who was escorted back into the observation area by husband and EMT. Patient complained of "lightheadedness and nausea, 20 minutes post vaccine." Patient was able to ambulate on her own and sat down in chair. Patient was conscious, alert, and oriented x4 and her skins were pale and clammy. Baseline vitals were obtained at 1332 by EMT while patient was sitting: blood pressure: 132/86, pulse: 91, respiratory rate: 16. Pupils were equal, accommodating, and reactive to light. Patient denied chest pain, shortness of breath, headache, blurry vision, and abdominal pain. Patient stated that the feelings of lightheadedness and nausea were improving. In addition, patient complained of left occipital/ neck pain. The pain was described as "sharp" and rated as a 2/10 on a pain scale. Bilateral pulses felt, motor sensation intact, and capillary refill was less than 3 seconds. Patient denied any reaction to the 1st COVID vaccine dose and denied any pertinent medical history. Patient claimed last oral intake was at 1030 when she had coffee and eggs. Patient was given water to sip on and an emesis bag. At 1338, chief complaint was reassessed. Patient claimed symptoms had resolved and denied any other complaints. Patient was conscious, alert, and oriented x4 and skins were noted to be improving in color and temperature. A second set of vital signs were taken at 1342 by EMT, while patient was standing: blood pressure: 129/84, pulse: 87, respiratory rate: 14. Pupils were equal, accommodating, and reactive to light. Patient was advised by Medic to sit for 10 more minutes. At 1350, patient stood up on her own. She advised Medic that she felt "much better." Medic educated the patient on when to contact their primary care physician with any other concerns and when to call 911, if symptoms warrant, or when to go to the ED. Patient then walked out of the site with a steady gait.
Chills followed by very hot.  Then very aching legs along with severe chills.  Finally on 2nd day, very weak.
29APR94 called to report silver dollar size swelling on rt arm of son; 29APR94 0905 mom called MD pt had shakes; instructed to go to ER;
Patient inadvertently given undiluted COVID vaccine bivalent booster dose. Patient monitored for 15 minutes post administration with no reaction. Error identified morning of 1/6/2023, physician notified, family contacted. Patient doing well and family will call if patient experiences any adverse effects.
0936 vs 92/60, 58, 20, 98%. Pt c/o ringing in both ears, tightness in head and skins were pale and diaphoretic.  Pt denies any SOB, rash, hives, dizziness.  Pt?s father is here with him and is his driver.  0946 vs 120/82, 69, 20, 97%.  Pt is feeling a bit better.  The ringing in the ears and tightness to head is gone, BP has increased and skins are drying and color is returning.  This is his first vaccine.  Pt did not want any further medical attention/paramedics called.  Pt and father were advised to call 911 if any further symptoms occur after leaving site.  Pt is feeling back to normal with skins W/D, no other symptoms.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 19-AUG-2015, the patient indicated for ZOSTAVAX was accidentally vaccinated with (Oka/Merck) VARIVAX (dose, route and lot# were not reported) instead. No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.