chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Doctor of pharmacy concerning a 48 year old male patient who on 19-JUL-2005 was vaccinated with a first dose of hepatitis A virus vaccine inactivated (manufacturer unknown) (Lot # not reported). On 17-NOV-2005 he received second dose of hepatitis A virus vaccine inactivated (manufacturer unknown) (Lot # not reported). On 03-NOV-2004 he received first dose of hepatitis B vaccine, recomb (manufacturer unknown) (Lot # not reported). On 17-APR-2005 he received second dose of hepatitis B vaccine recomb (manufacturer unknown) (Lot # not reported). On 19-DEC-2005 he received third dose of hepatitis B vaccine, recomb (manufacturer unknown) (Lot # not reported). On 19-MAR-2009 antibody titer was performed and were negative for both hepatitis A and B. At the time of on the report on 06-MAY-2009 the patient had not recovered.  Additional information has been requested.
HAD LOWER BACK PAIN FOR AWHILE PRIOR TO VACCINE, AND IT WENT AWAY AFTER VACCINE AND HAD STAYED GONE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included back pain. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced had lower back pain for awhile prior to vaccine, and it went away after vaccine and had stayed gone. The action taken with covid-19 vaccine was not applicable. The outcome of had lower back pain for awhile prior to vaccine, and it went away after vaccine and had stayed gone was not reported. This report was non-serious.
11/30/2022 I tested positive for COVID-19 I had extreme fatigue, muscle and body aches, chest congestion for about 4/5 days. I also have lingering fatigue. I had a telehealth appointment and was prescribed a course of Paxlovid. On 12/10/2023 I also tested positive and had the same symptoms as the last time I was positive. I was not prescribed Paxlovid.
I woke up covered in hives across my collar bone, arms and legs.  I took Benadryl which did not help.  I went to the urgent care that afternoon and was prescribed a six day regimine of steroids.  The hives were gone upon completion of the medicine.  On March 22nd, the hives reappeared and I was again prescribed a six day dose of steroids.  I had the second shot on March 23rd.  The hives reaappeared on April 1st.  I am currently taking a 15 day perscrition of Prednisone.
Pt reporeted dizziness and feelin like he has a low BP. Vitals: 139/68, 99, 19 -- > 126/69 VS m onitored.  Pt placed in T-berg position.  Pt given water. Pt stable and released from the vaccination site.
exposed to her 6 month old grand daughter who was positive; tested and received a positive test result, without symptoms.; tested and received a positive test result, without symptoms.; This is a spontaneous report from a contactable consumer.  A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration at the right arm on 30Dec2020 at a single dose for COVID-19 immunization.  Medical history included high blood pressure from 2001 and ongoing. There were no concomitant medications. Patient had the flu, shingles and pneumonia vaccines and a booster for MMR in the past 6 months. Patient was exposed to COVID-19 on 01Jan2021. Patient was tested on 07Jan2021 and received a positive test result on 08Jan2021. Patient does not have any symptoms. She was exposed to her 6 month old grand daughter who was positive. The doctor said he thinks it was a false positive. Outcome of the events was unknown.
The injection site is still swollen; The injection site is still swollen and painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (The injection site is still swollen) and VACCINATION SITE PAIN (The injection site is still swollen and painful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (The injection site is still swollen) and VACCINATION SITE PAIN (The injection site is still swollen and painful). At the time of the report, VACCINATION SITE SWELLING (The injection site is still swollen) and VACCINATION SITE PAIN (The injection site is still swollen and painful) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.
Had shot at 11:30 am.  Dizzy with chills by 1:00 pm.  Exhaustion took over immediately after. By next morning I thought I was better until I  was up and about for ten minutes. By 6:oo am, I was flu-ish and nauseous. I never vomitted through entire experience, but was nauseous off and on throughout.  I had a fever that went to at least 101 degrees. I was exhausted until this morning (Friday 4/30/21). I was hot and cold the entire time. My joints ached continuously. On the morning after the shot, I woke up with metal mouth. It is still there. Nothing tastes good. and my sense of smell is off completely. I heard this is unusual. I will bet that people who tried to report it were not happy with filling out a form of this kind and gave up.
Arm soreness after received the Pfizer Covid 19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose 2, single (Lot number: EW0173) at the age of 63 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: ER8733), administration date: 02Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "Arm soreness after received the Pfizer Covid 19 Vaccines". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Apr2021, outcome "recovered" (May2021), described as "Arm soreness after received the Pfizer Covid 19 Vaccines".  Additional information: She got the Prevnar 20 vaccine, and normally her arm is sore for a little while, which even happened with the COVID vaccines, Verifies that her arm was sore with all of her Pfizer COVID-19 doses. States that if you give her any kind of shot, her arm will hurt. Her mother had cancer, and when they did radiation on her, her skin turned green. The doctors took a bunch of pictures and put her in a medical journal. Arm soreness after received the Pfizer COVID-19 Vaccines began the night she received the vaccine and lasted about 2-3 days. No vaccines administered on same date with the Pfizer vaccine considered as suspect. AE(s) Did not require a visit to Emergency Room, Physician Office. No other vaccinations received within four weeks prior to the first administration date of the suspect vaccine.
Severe muscle weakness, joint pain in shoulders hips, groin area. worse in morning , or long seated period. Can't stand up from kneeling position
Sinus headache; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 16:45 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. The patient medical history included sinus headache (happens less than two times a year). The patient had known allergies which include penicillin allergy and common seasonal and household allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 09Mar2021 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 15:00, the patient experienced sinus headache just under 24 hours 1 day after vaccination. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of sinus headache and included treatment with regular strength tylenol. The clinical outcome of the event sinus headache was not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
On January 21, 2021 at the Clinic, an PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the vaccinator inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The vaccinator then alerted the APRN, who escalated the situation to the manager. The operations manager then contacted Quality. The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL.  After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them. Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of an abundance of caution.
RASH ON TORSO, ITCHY RED EYES. BENADRL TAKEN ORALLY
Covid symptoms started on 04/28/22; tested positive 04/28/22. That night I noticed my throat was sore and so I took a lozenges and went to sleep, woke up in the morning and had what I thought was allergies with congestion. I went to work and symptoms were getting worse and according to my smart watch my heart rate was high with just a little walking. I started coughing towards the end of the day and the congestion got worse. I stayed home and had a lot of fatigue and slept through all of it pretty much and at some point I was really cold and my temperature was never about 99.8. My symptoms lasted for 4 days. I also lost my taste and smell. I did a telemedicine appointment and was prescribed a cough suppressant and steroid Flonase which helped clear it up.
On 6/6/00, received vaccine and child had a seizure on 6/11/00 and was taken to ER. Had MRI and other tests done with no pathological findings. Physician was unsure of etiology and thinks this possibly allergy to pertussis.
Heart Failure; Bilateral DVT; Blood Clot; Exacerbation of pre existing medical conditions; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure), DEEP VEIN THROMBOSIS (Bilateral DVT) and THROMBOSIS (Blood Clot) in a 77-year-old male 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 Deep vein thrombosis ('had an episode of DVT 30 years ago').    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (Bilateral DVT) (seriousness criterion medically significant), THROMBOSIS (Blood Clot) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Exacerbation of pre existing medical conditions). At the time of the report, CARDIAC FAILURE (Heart Failure), DEEP VEIN THROMBOSIS (Bilateral DVT), THROMBOSIS (Blood Clot) and CONDITION AGGRAVATED (Exacerbation of pre existing medical conditions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and pre-existing medical conditions are confounding factors that may play possible contributory roles.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and pre-existing medical conditions are confounding factors that may play possible contributory roles.
15mo child rec'd vax 7FEB91; Had fever on 8FEB; High fever & lethargy on 9FEB on 10FEb positive sp tap which grew H. influenzae; Child was walking before event, now crawling;
After 4 or 5 days I started with an itchy spot on my left arm, after 2 days it was getting worst and I realized that it was next to the place that I received the Covid shot, it has being itchy, warm and red but not swollen, today the red area is getting larger but less itchy.
Soreness in all joints; Overall felt like a bad case of flu; Slept for 13-1/2 hours.; 12 hours after receiving vaccination Ihad a 100.5 fever; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on 24Mar2021 (at the age of 71-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic sinusitis, COVID-19, penicillin allergy, diary allergy, soy allergy and allergy to nuts. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the patient experienced "12 hours after receiving vaccination I had a 100.5 fever" and slept for 13-1/2 hours. On 26Mar2021, the following day the patient experienced soreness in all joints and overall felt like a bad case of flu. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 25Mar2021, the patient underwent lab test and procedure which included body temperature and result was shown as 100.5. The clinical outcome of the events "12 hours after receiving vaccination I had a 100.5 fever" and slept for 13-1/2 hours, soreness in all joints and overall felt like a bad case of flu were resolved with sequelae on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Celiac dx" (unspecified if ongoing), notes: Celiac dx; "erosive arthritis" (unspecified if ongoing); "gluten intolerance" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Iron dextran iv, reaction(s): "known allergies: Iron dextran IV", notes: known allergies: Iron dextran IV. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: Treatment of COVID-19; (17Jun2022) Positive, notes: Return of symptoms and positive test six days after completing paxlovid course. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was not pregnant at the time of vaccination. This report was about COVID-19 treatment. Patient did receive the vaccine. Patient had not received other medication in 2 weeks. Patient received COVID 19 Treatment as Paxlovid (Lot number- GA3567) from 07Jun2022 to 11Jun2022.  No follow up attempts are possible. No further information is expected.
VARIVAX administered post temperature excursion.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported  On 18-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX) injection, 0.5 milliliter (ml) once (lot number S032355 which has been verified to be valid, expiration date reported and validated as 14-OCT-2021) (vaccination scheme, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error). The administered dose of the vaccine was stored at a temperature of -9 degrees Celsius (C) to 8 C (-2.8 C), during a time frame of 5 hours and 2 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000677: US-009507513-2009USA001249: US-009507513-2009USA001303: US-009507513-2009USA001333: US-009507513-2009USA001367: US-009507513-2009USA001381:
Information has been received from a RN concerning an 81 year old male who on 11/06/03 was vaccinated in the mid arm with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed tenderness and an injection site reaction to include redness, edema and pruritus.  No treatment was required. Unspecified medical attention was sought. There was no product quality complaint involved. No other information was available at the time of this report. Follow up information from the physician indicated "we didn't inject pt." and that another physician or staff at another office injected the pt. Additional information is requested.
when reconciling doses in  noticed that patient had received a dose of Janssen vaccine from a pharmacy 5/8/2021. Unable to reach patient to verify as phone number is disconnected
Received immunization at approx 15:00 on 03/04/03. Around 19:30 began screaming and could not be consoled. This lasted at least 2 hours when she finally fell asleep. Had called the doctor who said to give Tylenol which the mother was already doing. Denied limpness, paleness, fever, convulsion or irritation of injection site. When awoke the next AM was back to normal.
Shingles breakout on her neck, where she usually has shingles breakouts; 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.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years 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 case details were reported as follows: The age at vaccination was not reported. The patient received dose one of Shingrix and then had a shingles breakout on her neck, where she usually had shingles breakouts. The reporter was busy and did not provide further details during this call. The reporter consent to follow up.
Vaccine given afternoon of April 18th. Muscle aches/pain woke patient at 5 am April 19th. Pt was extremely sore (whole body) and slept the entire day and through the night. Pt awoke April 20th feeling normal except "goose-egg" and sore arm where injection was given. Pt also states that arm was/is itching slightly, some diarrhea and upset stomach.
Shingles; postherpetic neuralgia; Hearing problems; Balance problems; Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or around 28-SEP-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), (lot #, administration route, anatomical location and expiration date were  unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles, postherpetic neuralgia, hearing and balance problems. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, patient symptoms have resulted in physical limitations not present prior to using of the vaccine. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Patient sustained severe and permanent personal injuries. Patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The aforementioned events were considered as disability.
less than 24 hrs from shot pt was brought back to MD because could hardly breathe; then was adm into hosp & inc sweating was given Theoliair & Pedipred & went home on both still not clear when lt hosp;
Customer came in with severe bruising at injection site, it had described to purple and yellow on 9/14/17 - started late day of injection.
Redness, swelling, hot, itchiness still present after 8 days. Urgent Care provider started me on oral Keflex. Very swollen lymph nodes to left axilla and near left clavicle. Moderate to severe shoulder pain. Unable to sleep on my left side. Inflammation to left shoulder.
Vaccine error - patient was given an adult Hep A instead of a ped/adol Hep A, no adverse reactions reported by patient.