chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Son is 10 years of age almost eleven/got vaccinated last Friday the 13th; Son is 10 years of age almost eleven/got vaccinated last Friday the 13th; headache / head started hurting; fever; cough; sore throat; This is a spontaneous report from contactable consumer. This consumer (patient's parent) reported for her son. A 10-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 13Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported by reporter that, her "son is 10 years of age almost eleven". He got vaccinated last Friday the 13th, then on Sunday night his "head started hurting and then on Monday morning he woke up with a headache and a sore throat and it lasted until last night." The patient additionally experienced fever and cough on an unspecified date in Aug2021. The reporter was concerned as her son will be 11 in January but she really, could not wait a year and half and she know it would not be a year and half but she was like panic. As per reporter, the reactions are all gone now. The reporter added the patient was all fine now and she was not worried. Added "we did have to take him to get a Covid test". Reporter was not willing to complete the report, so no further probing was done. Limited information available over the call. The outcome of the events was reported as resolved on an unspecified date in Aug2021.  Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Next day developed severe headache and nausea. Improved after 72 hours after taking Tylenol.
7/7/00, had raised hives over body, itchy and swollen eyelids. On 7/9/00, sick appt in office and dx'd with allergic reaction. On 7/21/00, hives continued 4-5 x since 7/7/00. Treated with Atarax, prednisone and Benadryl. On 7/24/00, mom concerned and Zyrtec prescribed.
Patient was given a 0.1 ml dose of the Moderna COVID vaccine rather that the 0.5 mL dose. this was caught by the clinical staff and the patient was revaccinated with a full o.5 mL dose in the opposite arm.
8 hours after receiving shot, almost to the minute 8:20pm, I spiked fever of 104, severe headache, aches and pains throughout all bones, muscles and joints.  Broke fever after 5 hours but headache remained severe for 18 hours.  Muscle fatigue remained for approximately 2 days.  Remained in bed until symptoms passed.   Arm swelled up on 4/4/21, area where received shot.   It was almost everything I experienced with COVID in Nov 2019 over the course of 3 weeks squeezed into 24 hours, having suffered before I knew to go to bed and didn't go to ER.   If I hadn't experienced this before I would have gone to ER.
Redness on deltoid (L) area and sore arm when moved up. He says it is getting better than it was initially.
1 month after receiving my second Covid vaccine I developed spontaneous hives. It started on my hands, then my feet and over a couple of months happened all over my body. I have seen a dermatologist and an allergist both calling it spontaneous chronic urticaria most likely from the vaccine. I was started on Zyrtec which caused weight gain over several months and when I stopped it the hives got 10 times worse causing my throat to swell and happened several times a day.
COVID Vaccine Breakthrough Case  J&J Dose 5/6/21 (1808980) COVID Positive 11/24/21 COVID Positive 11/26/21  11/26/21: History is obtained from patient as well as by personal review of records.  Patient has advanced amyotrophic lateral sclerosis, functional quadriplegia and is nonverbal.  Communicated to me by blinking and slight nodding.  She reportedly uses Eye gaze device.  She follows with Dr. (neurologist ).   She and her husband tested positive for  SARS-CoV-2 reportedly on 11/24/2021.  She had fever, worsening cough of 1 day duration.  Worsening difficulty in swallowing on top of chronic dysphagia.  Decline in general condition. She had temperature of 100.7° F in emergency department. She was hypoxic with pulse ox of 86% on room air.  She uses AVAPS  at nighttime.  11/30/21: Patient is hemodynamically stable to discharge home  Patient to continue with azithromycin daily for 5 days  Patient to follow-up with PCP in 1-2 weeks
I started to notice adverse symptoms the day after I received my second vaccination dose which included a low-grade fever, tingling in the lower extremities, extreme fatigue, and a headache.
Started as though I had a sinus infection or a cold. Heavy nasal drainage. Symptoms as if I had bronchitis. Congestion just kept pouring into chest. Sneezing, coughing and then started to get that heavy congestion in the chest. It took probably a month after just to get clear of that cough. So I went to the doctor 01/24/2022- still had congestion and cough. The symptoms were like a cold then started into pressure into chest and diarrhea. Chills and fever. When I tested for COVID, they came positive 12/31/2021 and 01/03/2022, I thought it was a cold or bronchitis. 01/08/2022- came back negative but was still having congestion. 01/24/2022 that came back negative. Still ongoing nasal drainage and cough from time to time.
PATIENT WAS GIVEN UNDILUTED PEDIATRIC DOSE INSTEAD OF ADULT DOSE
After vax. administration, pt reports immediate onset dyspnea, headache, tinglings b/l hands and feet. Normal BP, Normal RA pulse ox. Sore throat started_____am, "worst headache" in her life, continued numbness/tingling hands and legs. Did not seek med attn that day. Symptoms dissipated after 1 month.
24 hours later the patient was sweaty; did not get a good nights sleep/Tossed and Turned; Sore left arm for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (24 hours later the patient was sweaty), INSOMNIA (did not get a good nights sleep/Tossed and Turned) and VACCINATION SITE PAIN (Sore left arm for 3 days) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Bronchitis.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]), FINASTERIDE, ROSUVASTATIN CALCIUM (CRESTOR), NIFEDIPINE, RABEPRAZOLE SODIUM (ACIPHEX), HYOSCYAMINE SULFATE (LEVSINEX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left arm for 3 days). On 09-Feb-2021, the patient experienced HYPERHIDROSIS (24 hours later the patient was sweaty) and INSOMNIA (did not get a good nights sleep/Tossed and Turned). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 10-Feb-2021, VACCINATION SITE PAIN (Sore left arm for 3 days) had resolved. At the time of the report, HYPERHIDROSIS (24 hours later the patient was sweaty) and INSOMNIA (did not get a good nights sleep/Tossed and Turned) outcome was unknown.      This case was linked to MOD-2021-410038, MOD-2021-410019 (Patient Link).
Developed vesicular lesions which progressed to blood blisters/scabs; Itchy. RX OTC hydrocortisone and follow up in 2 weeks
Body aches, loss of taste and smell, achy, tired, congested, shortness of breath
Received MMR 12/4/19. Minimal interval for live vaccines not met. Varicella vaccine to be repeated at appropriate interval.
Started with little red bumps that itched; lower right arm had a rash from elbow to wrist; This is a spontaneous report from a contactable consumer (patient) received via a regulatory authority. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection),via an unspecified route of administration, administered in right arm on 09Feb2021 at 10:30 (Batch/Lot Number: EM9810) (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. Medical history included diabetic and known allergies to Penicillin, Sulfa and Codeine. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.  Concomitant medications included atorvastatin; glipizide; insulin degludec (TRESIBA) and Vitamin D; all taken for an unspecified indication, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The patient experienced started with little red bumps that itched then lower right arm had a rash from elbow to wrist on 16Feb2021 at 09:00. The patient received no treatment for the events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
hot, red, swollen upper arm;Annual follow-up received 11/6/00 provided no additional data.
Initial and follow-up information has been received from a certified medical assistant (CMA) concerning a 15 year old female with no medical history who on 16-FEB-2007 was vaccinated IM in a deltoid (unspecified) with the first 0.5 mL dose of Gardasil (lot #655619/1427F).  On 19-JUN-2007, the patient was vaccinated IM in the right deltoid with a second 0.5 mL dose of Gardasil (lot #657736/0389U).  There was no concomitant medication.  On 29-AUG-2007, a Papanicolaou test (PAP smear) was performed on the patient during a routine gynecological examination.  Subsequently, the PAP smear was positive for human papilloma virus (HPV).  The medical assistant reported the event as a vaccination failure.  The patient's outcome was unknown, although, the medical assistant reported that the physician was monitoring the patient.  Additional information is not expected.
lIght headed, tingling of fingers, pale, diaphoretic, c/o tingling of the throat briefly.  sips of gatorade.  hypotensive: 80/40, 88;  placed on stretcher semi-trendelenberg . BP: 120/P,   No LOC.
hives 1 hr after leaving, monitoring area escorted to ED -> Benadryl, monitored For 3hrs allergy consult recommended -> Eval 1/6 -> Recommend 2nd Dose C? 30 min observation Recommend 2nd dose 1/21/2021 -> No adverse reaction
Pt came in our office on 8/3/11 c/o (L) arm swollen. Pt was seen by one of our providers got treated w/KEFLEX 250mg/5 & children's MOTRIN. An appt for follow up has been schedule in 3 days.
pt devel pain & erythema on lt deltoid @ site;pt devel fever 100.3 (also has OM);pt seen 11/11/99 w/T96.4;mild erythema & induration of lt deltoid & bilat OM;started on pediazole;
covid 19 positive; covid 19 positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An 8-year-old male patient received BNT162b2 (BNT162B2), on 13Nov2021 as dose 1, single (Lot number: FK5127) and on 04Dec2021 as dose 2, single (Lot number: FL0007) at the age of 7 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 15Jul2022, outcome "recovering" and all described as "covid 19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive, notes: covid 19 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.
This case was reported by a physician via sales rep and described the occurrence of itchy rash in a 61-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included asthma (uncontrolled) and allergic reaction to antibiotics (doxycycline allergy). Concomitant products included XOLAIR. On 2nd July 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 6th July 2018, 4 days after receiving SHINGRIX, the patient experienced itchy rash, urticarial rash and widespread rash. In July 2018, the patient experienced blood blister. The patient was treated with Steroids. On an unknown date, the outcome of the itchy rash, urticarial rash, blood blister and widespread rash were unknown. It was unknown if the reporter considered the itchy rash, urticarial rash, blood blister and widespread rash to be related to SHINGRIX. Additional details were provided as follows: On Friday, the patient presented with an urticaric and pruritic rash which started on his butt, spread to his side, groin and thighs. It spread to wrists and hands. When physician saw the patient on Monday 9th July 2018, the patient's wrists and hands were covered in blood blisters, as well as the widespread rash on the patient's torso. The physician prescribed steroids to the patient and had a follow up next week. A metabolic panel was essentially normal except for slightly elevated blood urea nitrogen and blood glucose. The physician was not 100 percent convinced that reaction was from SHINGRIX. Lab Comments: In July 2018, the metabolic panel was essentially normal.
Sciatic nerve bundle for left leg. Severe nerve pain in sciatic. Severe nerve pain under patella propagting out to nerves surrounding the knee but especially the inside of knee and the patellar tendon. Crippling pain: Could not walk on or work.
COVID Breakthrough Case  Pfizer Dose 1 3/18/21 (ER2613) Pfizer Dose 2 4/8/21 (EN6208) COVID Positive 12/8/2021  12/10/21:Patient is a 72-year-old female patient comes to the hospital with complaints of extreme generalized weakness and shortness of breath which have been getting worse in the last few days.  Patient has been vaccinated along with her husband for the COVID-19 infection.  She was in a gathering with friends on third of December and was possibly exposed to the infection.  Since then patient has been progressively feeling very weak, fatigue, decreased appetite and has had dry cough which is not resolving.  She has no fever/chills.  Patient was seen as an outpatient in the clinic but was discharged home for conservative treatment at home.  She came to the emergency room as she was getting progressively worse.  Patient is being admitted for further care.  She has history of type 2 diabetes, depression, fibromyalgia, hypertension, GERD and asthma. Shortness of breath present with minimal ambulation and dry cough present.  1/3/22: Patient presented with hypoxia COVID pneumonia on admission as noted.  Was intubated from outside facility and transferred secondary to ICU bed availability.  Patient was intubated on arrival, pulmonology was consulted. Patient was started on course of remdesivir, pr sit to neb, Decadron, empiric antibiotics.  Pulmonary critical care assisted during admission, developed severe ARDS had to be prolonged and placed on Flolan, finish multiple course of antibiotics ceftaz, Zosyn, vancomycin.  Due to develop AFib was on metoprolol, Eliquis.  AKI resolved.  Did develop edematous tongue suspected secondary to prolonged pronating.  Unfortunately patient was not able to be weaned off vent and after prolonged intubation.  A decision was made to trach and PEG patient.  This was done on 12/29. Sedation was gradually weaned off patient had some minimal response f opens eyes however not verbal and tracking, retracts to pain.  Considering condition request was made transfer to select Specialty facility for ongoing care and management.
This report was received from GSK and was assigned manufacturers #A0744305A for PEDIARIX. This was originally reported by a health professional concerning a 7-week-old male with no history of previous influenza virus vaccinations who on 16-JUL-2008 (also reported as 16-Jun-2008) was vaccinated with a first dose of ROTATEQ (Lot number 660848/0303X route and site unknown, unknown of previous doses also reported as unknown). Suspect therapy included a first dose of PREVENAR (Lot number C86145 route and site unknown, number of previous doses also reported as unknown) and a first 0.5 ml dose into the right upper thigh of PEDIARIX (Lot number AC21B150AA, route unknown). It was reported that on 16-Jul-2008 (also reported as 16-JUN-2008) immediately after vaccination with PEDIARIX the patient experienced inconsolable crying. The patient was taken to the emergency room by his mother, but he was not admitted to the hospital. The inconsolable crying lasted until 22:00 on the same day that the PEDIARIX was administered. The reporting healthcare professional considered the event to be disabling and clinically significant (or requiring intervention). At the time of reporting the event was resolved. The healthcare professional considered the event to be probably related to vaccination with PEDIARIX. Follow-up information was received from a nurse who indicated that the previously reported concomitant vaccines PREVENAR and ROTATEQ were co-suspect for the inconsolable crying. The nurse provided the vaccination date of 16-Jul-2008, which was previously reported as 16-Jun-2008. In addition, the nurse indicated that the event was not disabling as was previously reported. The PEDIARIX series was neither discontinued nor delayed. The reporting nurse considered the event to be possibly related to vaccination with PEDIARIX, but also stated that the child's parent may have been overly concerned. The event was reported to be resolved as of 16-Jul-2008. The reporter considered crying to be clinically significant and was therefore considered to be an other important medical event.
pt recv vax 26AUG97 & approx 2-3 wk post vax pt devel swelling of knee joints & was hosp for diagnostic eval;pt had fluid removed from knees while @ hosp & approx every 2-4wk thereafter;tested for polyarthritis;
09/05/22 presents to Birth Center Triage for "contractions" "38w0d". PMHx of "Hypertension"
A physician reported that a pt received a dose of Prevnar vaccine (date not specified) and subsequently developed a fever of more than 101 degrees F. No further information was available a the date of the report. The reporter indicated that other patients experienced this event but was unable to specify the number of patients involved. Additional reports will be generated when identifying information is provided.
soreness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) outcome was unknown.            No relevant concomitant medication information provided.  No relevant treatment medication information provided.
Weakness and fatigue, heart rate over 200, cardioversion needed twice, test positve for covid on 8/26/21 after covid vaccines were given  on 2/26/21 and 3/26/21
Within 4-6 weeks of the second vaccine, patient started showing signs of shortness of breathe, swollen feet, cough, weak muscles, tired and no energy. patient had been walking with walker up to that point 5 times a week for 15-20 minutes. Since these symptoms began, he was not been able to walk more than a few feet without resting and being out of breath.  He had been put on a diuretic and inhaler which didn't seem to be doing much. He saw his primary and heart Dr since the beginning of June. On June 24th he was admitted into the Hospital with Congestive Heart Failure. After blood tests, he was also diagnosed with Leukemia. A week later, on July 1, 2021, patient passed away.
Patient was administered and expired PNEUMOVAX 23.; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 15-FEB-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot number U022984 with expiration date 29-JAN-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) (expired product administered) No other issues or concerns noted. No product quality complaint or temperature excursion.
Fever; body aches/general soreness; his head hurts; This is a spontaneous report received from a Pfizer sponsored program from a male contactable consumer(patient) reported for himself. A male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of Covid-19 vaccine on 11Mar2021 at single dose for Covid-19 immunization. Patient stated he got his first dose of the Pfizer vaccine 11Mar2021 and he got the second dose yesterday 01Apr2021. Patient relays that he didn't think to ask the pharmacy when got the vaccine and he called them this morning to ask about taking an anti-inflammatory afterwards. Stated he was told it was ok. Stated he talked to his primary care provider before he got the 2nd dose and they mentioned that for 72 hours before and 72 hours after not to take an anti-inflammatory. Patient stated he thought he would contact Pfizer to get an exact answer. Stated he has a fever over 100 now and is trying to combat that. Stated he had been on hold for an hour and a half. Patient declined to make a report at this time. Stated to be honest what he was seeing is fever and body aches and he wanted to know if he can take paracetamol (TYLENOL). Reporter seriousness was unspecified. Patient stated he was a pharmacist intern but he didn't finish school though. Patient clarified that he did not make a report with the previous agent, that they just got contact information. Patient called because he wanted to know if he could take Tylenol after getting his second dose of the covid-19 vaccine yesterday (01APR2021). Patient asked his medical provider and was advised to take Tylenol 72 hours before and after the covid-19 vaccine and the Pharmacy where he was administered with the vaccine told him it was okay to take Tylenol. According to patient, he wanted to take Tylenol because he was feeling general soreness, body aches and his head hurts, his first dose was given on 11Mar2021. Outcome of events was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.