chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is one case out of a cumulative total of 238 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 11 November 2014. These 238 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 11 November 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 1 dose of PENTACEL on 10 December 2012, batch number C4293AA, a dose of DAPTACEL on 11 February 2013, batch C4154BA, a dose of PENTACEL on 11 April 2013, batch C4294AA and a dose of DAPTACEL, batch number C4508AA on 24 February 2014 (routes and sites not reported). On 28 September 2014, the subject developed a cough and paroxysmal cough on 20 October 2014 without a whoop approximately 7 months after the last dose. The subject experienced posttussive vomiting on an unreported date. The subject did not experience cold symptoms. The subject experienced sleep disturbance and did not experience apnea. Laboratory testing included a negative PCR on 31 October 2014. Chest x-ray findings were positive for pneumonia. Corrective treatments consisted of azithromycin starting on 31 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 03 November 2014, the subject's cough was still persisting. The duration of the cough was reported at that time as 36 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case, and was OB related. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
A nurse reported the occurrence of an injection site reaction in a 4-year-old male who was vaccinated with dephtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  The subject's medical history, concurrent conditions, or concurrent medications were not provided.  The subject experienced no adverse events following previous immunizations.  on 09/11/2002, the subject received his fifth injection of Infanrix (lot DTPA572A2) into the left arm.  On that same day, he also received an injection of inactiated poliomyelitis virus vaccine (IPOL) at an unspecified site.  Within 24 hours post-immunization, on approximately 09/12/2002, the subject developed an injection site reaction characterized by "a red, swollen, tender area 9 inches in diameter at the injection site."  The injection site reaction resolved within 72 hours.  Initially, the reporter stated that the event was "probably related" to Infanrix administration.  On follow-up, the reporter stated that the event was "possibly related" to Infanrix administration.  Comment:  This report has been linked to report A0388102A due to same reporter.
Patient contracted COVID after being fully vaccinated.  Booster 11/17/2021 (not infected in the two weeks after) 0.25mL; IM; Right Deltoid; 020F21A Fever, cough, headache, sore throat, fatigue, muscle aches.
Breakthrough COVID-19 case with symptom onset 9/5/2021: Shortness of breath/difficulty breathing. Hospitalized 9/5/2021-9/6/2021. Patient was admitted to the hospital the same day of testing positive at the facility. He was discharged the next day on 9/6 but then re-admitted the same day with bilateral pulmonary embolism. At time of hospitalization, noted to have pneumonia, abnormal chest x-ray, and acute respiratory distress.
Information has been received from a registered nurse concerning a 4 month old male who on 17 Nov 2006 was vaccinated with a first oral dose of Rotateq (human bovine). No problems were reported. No other information was provided. Additional information has been requested.
Patient's arm is red, swollen and tender from shoulder to elbow. She says it's been hurting for over a week.
Went outside and my face was really hot. A rash developed and more severe then the first one, blood pressure was elevated. Got Benadryl. Had a headache.
After first kid severe body pain - vomited for 24 hours ftom pain. Thought it was a normal reaction. After 2nd one, developed headache 24 hours after, then body pain and fatigue, chest pain and cough and severe fatigue. I?m still sick. It?s been 11 days of feeling like this. I had a similar reaction to a flu shot years ago, which is why I don?t get it. I?m never sick. I?m going to thr dr today but I can?t imagine what he?ll be able to do.
April 2021: Muscle Spasms after 1st Moderna Vaccine; unknown tx May 2021: Folliculitis after 2nd Moderna Vaccine: unknown tx
Pt complained of feeling extremely painful at the injection site. And he felt hurt moving the injection arm. 98.6 degrees F. He was advised to take ALEVE to relieve the pain. The event was reported approximately 15-20 min after the injection.
Patient contacted the pharmacy the following day. Chief complaint: pain radiating from injection site to hand and to chest; also unable to raise arm past head. Recommended OTC pain medication and cold compress.
pt started to experience sweating, dizziness, lethargy and low blood pressure approximately 5-8 minutes after receiving his covid booster.   i gave him water to drink, took his blood pressure and a cool clothe for his forehead. he remainded upright in a chair and was assisted by his wife. i had my technician call 911, because his blood pressure was very low...approximately 70/55.  I also gave him a gatorade to drink.Approximately 20 minutes after he received his vaccine, the paramedics arrived and took his bp and vitals, he was beginning to feel a little better. he refused to go to the ER. the last reading by paramedics of his bp was 100/60 upon standing. he and his wife rested about 15 more minutes and then they took an Uber home at about 8:50pm
Headache, Myalgia, Fever, NauseaVomiting, Symptoms reported resolved 10pm 1/22/2021 Narrative:
Approximately about 2 weeks after my vaccination (2nd dose) I experienced the following symptoms: Red spots on my back which was unusual and it spread on my chest then my arm and it just spread out all over my body. It was extremely itchy as well. I called my dermatologist and scheduled an appointment and was examined. The doctor told me he has never seen a rash like mine (full body rashes) and was told it might've been an allergic reaction and was put on steroids and antihistamine. It did help improve my condition overtime it took around 6 weeks for me to recover.
Rec'd phone call from pt's mother. Mother reported pt has been sleeping x 2 days off and on and running "ever". At injection site with small red bumps around injection site (per mom's report). Inst. to follow up with PMD or ER of choice.
paresthesia which started in right hand and then left foot and has since spread to both hand, both feet and both entire legs./a vibrating sensation in some areas/ Pins and needles; burning cool sensations; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Sep2021 10:15 (Lot number: FF2588) at the age of 43 years as dose 1, single for covid-19 immunizations. Relevant medical history included: "Palindromic rheumatism" (unspecified if ongoing), notes: Other medical history: Palindromic Rheumatism; "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Sep2021, outcome "not recovered", described as "paresthesia which started in right hand and then left foot and has since spread to both hands, both feet and both entire legs. /a vibrating sensation in some areas/ Pins and needles"; FEELING COLD (non-serious) with onset Sep2021, outcome "not recovered", described as "burning cool sensations". Therapeutic measures were taken as a result of paranesthesia, feeling cold.  Additional information: 3 weeks post vaccine caused began having paresthesia which started in right hand and then left foot and has since spread to both hands, both feet and both entire legs. Pins and needles, burning cool sensations, and a vibrating sensation in some areas. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in two weeks.    No follow-up attempts are possible. No further information is expected.
After 15 minutes of monitoring post injection, I developed itching to left shoulder with diffue hives to shoulder and chest
EXTREME PAIN TO LEFT SHOULDER WITH PAIN EMITTING DOWN THE OUTER PORTION OF THE ARM. MORE INTENSE PAIN WITH CERTAIN MOVEMENTS AND WHILE ATTEMPTING TO SLEEP AT NIGHT. SHOULDER IS NOW BEGINNING TO "LOCK" MAKING THE PAIN ALMOST UNBEARABLE. PHYSICAL THERAPY FOR 4 WEEKS NOW AND AN X-RAY THAT REVEALED NO ABNOMALITIES.
Patient is a 84 y.o. female with medical conditions as above, who presents for evaluation of a red hot right arm following a PCV13 immunization on 6/30/2017. She is accompanied by her daughter, who is her primary caregiver. The patient received a PCV-13 vaccine as a part of health maintenance at her first visit here a week ago. That visit was to f/u hospitalization for pneumonia and to establish care. Her daughter check with her the first 2-3 days after she got the vaccine and the patient said that her arm was not hurting. On July 5, and 6, the patient became more lethargic and confused, and her daughter looked at the right upper arm on 7/6 and noted that it was swollen, red and hot to touch. She sent a note through website and we called to f/u. As there was a 6 day delay in developing pain and redness, and a vaccine reaction should have been improving by there, I was concerned about cellulitis. I started the patient on cephalexin yesterday, sending in an order by phone. Today daughter says that her mother's arm is less swollen and tense, and the redness is less (see photo below). In addition, the patient's mental status is improved and almost back to baseline. Her appetite is better. She is able to respond to questions today although she can't recall the sequence of events around her arm pain.
Parkinson's symptoms returned as if not taking medication. Slowness, stiffness, loss of coordination, etc. got worse progressively over the following days after receiving 2nd Moderna vaccine. Have not resolved 10 days later.  Sometimes throughout the day I function ok and at other times I act as though I am not taking any medication to control Parkinson's. I am currently in physical therapy and it is very obvious. I have lost flexibility, speed, and coordination since the vaccine.
This spontaneous report as received from a nurse refers to a 17 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 29-APR-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Alopecia areata starting and growing approx 6 mos post 2nd vaccine dosage.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a 49 year old female patient with no medical history. The patient had an unspecified reaction to tetanus toxoid on an unknown date. On 02-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (lot # K004930 with expiry date: 16-MAR-2015; strength, dose and route of administration unspecified) indication reported as: "requested to receive shot". The patient did not take any concomitant medication. In October 2014 (exact date unknown), the patient experienced a swollen and red arm from the deltoid to the elbow. The patient sought medical attention via visiting the physician. No laboratory test were performed. The outcome of the events was reported as not recovered at the time of report. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced HEADACHE (slight headache). At the time of the report, HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant were reported. No treatment were reported.   This case was linked to MOD-2022-569890 (Patient Link).
had flu like symptoms; achy; feverish; headache; chills; just decreased mobility; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms, pain, fever, headache, chills and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, pain, fever, headache, chills and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, fever, headache, chills and mobility decreased to be related to Shingrix.  Additional details were provided as follows:  This case was reported by patient herself. The age at vaccination was not reported. The patient received a dose of Shingrix on the high up on the deltoid. The patient stayed in chair most of the day. About 36 to 72 hours later the issues were resolved. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter.
Approximately 18 hours after the vaccination, I started to feel unusually hot. I got up to walk to a different room and had white flashes in my eyes and started to get dizzy. I then sat down and started sweating all over and shortly after I fainted.
Swelling and redness around the injection area that hasn't gone away completely in 3 weeks
Sore throat Swollen uvula  Swollen tongue Painful painful tongue Splotchy tongue Loss of taste
Large, red, injection site reaction 1-4 cm x 12 cm. Start day after injection. Warm to touch. Treatment: MEDROL DOSE PAK. Resolved after treatment with steroids.
Second dose: muscle aches, pains; Second dose: muscle aches, pains; Second dose: extreme fatigue; Second dose: difficulty walking; felt like she was hit by a truck; This is a spontaneous report from a contactable other HCP (patient herself). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6198, Expiration Date: 30Jun2021), via an intramuscular route of administration, administered in Deltoid Right on 11Mar2021 11:00 as dose 2, single for COVID-19 immunisation (Age at Vaccination was 62 years). The patient medical history included breast cancer, haemochromatosis, had a double mastectomy and is post chemo (Chemotherapy), high blood pressure, GERD from an unknown date and unknown if ongoing, lymph nodes removed on her left side on an unspecified date. Concomitant medications included Omeprazole taken for GERD, Tamoxifen taken for anti-cancer, Losartan taken for high blood pressure all from an unspecified start date and ongoing. It was stated that, she did not receive any other new medications within the 2 weeks prior COVID vaccination. she was not on any blood thinners or Aspirin. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, Expiration Date: 30May2021), via an intramuscular route of administration, administered in Deltoid Right on 20Feb2021 as dose 1, single for COVID-19 immunization (Age at Vaccination was 62 years) and experienced no side effects, no arm soreness. On 11Mar2021 14:00, the patient experienced second dose: muscle aches, pains, extreme fatigue, difficulty walking, felt like she was hit by a truck. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FE3690, Expiration Date: 30Nov2021), via an intramuscular route of administration, administered in Deltoid Right (Right upper arm) on 29Oct2021as dose 3, single for COVID-19 immunization and experienced bleeding and bruising. The outcome of the events muscle aches, pains, extreme fatigue, difficulty walking, felt like she was hit by a truck was recovered on 12Mar2021 04:00 (Then about 14 hours later, everything was gone).  Medical conditions: Caller adds none of the conditions mentioned should be related to today vaccine  Description of Product Complaint: Description of complaint: Calling confirms she is a Registered Nurse, but she is calling on behalf of herself in regard to the COVID-19 vaccine. The caller believes the person administering the vaccine hit a blood vessel with that much bleeding.   Follow-up attempts are completed. No further information is expected.
Vomiting, lethargy, high fever for 2 days. Inconsolable crying, refusal to eat, weight loss, difficulty sleeping for following 2 weeks.
My son had body aches; My son had fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (My son had body aches) and PYREXIA (My son had fever) in a 20-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced MYALGIA (My son had body aches) and PYREXIA (My son had fever). At the time of the report, MYALGIA (My son had body aches) and PYREXIA (My son had fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO Concomitant medication was reported No treatment Drug was reported   This case was linked to MOD-2021-344209 (Patient Link).
The day after my third dose, my arm started hurting and I felt tired. The next day, I started feeling better, but the day after that, I started having generalized myalgia and joint pain. Over the next couple of weeks, my Enthesitis pain became worse. There was stiffness and peripheral joint pain. About two and a half weeks later I was having trouble standing and could not walk very well. My fatigue increased as well. My doctor switched my medications at three weeks after my dose. I started on 60mg of prednisone with a slow taper over three weeks. In addition, they stopped Taltz and added methotrexate.
Information has been received from a female patient who on 26-Nov-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck). On approximately 26-Nov-2008, since received the ZOSTAVAX, the patient developed an intermittent rash on her abdomen. The rash was characterized by flat, red lesions that were itchy. The rash was localized to the abdomen and got worse in dry weather. It is unknown if the patient sought medical attention. At the time of reporting, the patient had not recovered. No further information is available.
vials that went through a temperature excursion being used; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vials that went through a temperature excursion being used) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that went through a temperature excursion being used). At the time of the report, PRODUCT STORAGE ERROR (vials that went through a temperature excursion being used) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   The temperature went down to -2C and some that went down to -4.4C. They are now back to refrigerated temperature.
Patient presented very anxious prior to vaccines; delayed administration due to patient not cooperative and resisting with 2 nurses present as well as parent. Patient's mother responded in hostile manner which escalated patient's anxiety levels. Patient did sit still and cooperate for vaccines; requested both in right arm and immediately after doses given patient responded with "shaking" movements to whole body, tense presentation, dusky appearance to skin, tearful and non-verbal which lasted 2minutes. Patient vitals obtained.
I started hearing sounds in my head in my ears; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that about 2 weeks ago patient started hearing sounds in her head in her ears, went to the Doctor on Monday, gave me some antibiotics but they are not helping said it could be an allergic reaction, said a lot of people were reporting and saying, cause it started right after second dose. Clinical outcome of the event was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 38-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EL3247), on 21Mar2021 as dose 2, single (Lot number: EL3247) and on 22Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 38 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 14Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown, notes: if covid prior vaccination; (14Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.  ; Sender's Comments: The reported Covid 19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Approximately 15 minutes after vaccination, the patient started to experience severe pain in the lower back the wrapped around to the chest. The duration of the reaction was approximately 3 to 5 minutes and then the pain was gone and patient felt fine.