chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional and refers to a 4 patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 27-AUG-2015, the patient were vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K016295, expiration date 28-APR-2016) (strength and route of administration were not reported). There was no concomitant medication reported. No adverse effects were reported and no product quality complaint was involved. additional information has been requested.
On the morning of December 7, 2019, Patient noticed pain & swelling of her Right upper arm where she received the vaccine. Her arm was red near the injection site and redness started to move over the next 24 hours. Pt felt fatigued & burning in arm. The area of discomfort and redness in upper arm seems to have stopped expanding, but is not yet resolving. She denies any pruritus in that area or anywhere else in the body. No swelling or itching of her throat. She was breathing comfortably in the office. No history of past reactions to vaccine. Has received flu vaccine in the past without incident. This was her first pneumococcal vaccine.
I feel sick; I have problems with my stomach; This is a spontaneous report received from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient have to get second vaccine today but cannot go because patient feel sick, patient have problems with stomach. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Stabbing heart pain. Shortness of breath. Weakness in right hand (opposite the arm vaccinated). Extreme joint pain to the extend of difficulty walking. Symptoms abated strongly after 48 hours with the exception of tightness in chest.
This spontaneous report as received from a physician refers to a 22 years old female patient, who approximately in 1997 (when she was 16 or 17 years old) was vaccinated with a dose of GARDASIL (dose, frequency, route and lot number were not reported. No other co-suspects were reported. No concomitant medications were reported. The physician reported that the patient "recently" had a pap smear that indicated an infection with type 16 of HPV. The physician believed it was a low grade lesion. No treatment information was reported. It was reported that it did not know if the patient received all GARDASIL doses at the correct intervals. The patient did not sought medical attention. At the time of the report, the patient's outcome for the adverse event was unknown. The relatedness of the adverse event for GARDASIL was unknown. Additional information has been requested.
Shingles rash; Shingles rash; 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.   On 16th December 2020, the patient received Shingrix. On 18th December 2020, 2 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was pharmacist, received shingrix on wednesday and got shingles rash on friday before date of reporting. The patient stated that it was not listed as a side effect but she had shingles. The reporter did not consent to follow up.
Pt's Symptoms were hoarsness, difficulty breathing, rapid heart beat, and throat was closing up.  The treatment by the PCP was an Epinephrine injection and pt. was given a Benadryl 50mg- 1 po q4-6 hrs Rx.
Tenderness in arm pit, cease of elbow and down the arm to wrist. Tenderness lasted about 10 days and started to get better. At about day 21, the tenderness came back, but I could feel the swelling in my upper left chest and down my left side of my chest. Tenderness came back in the cease of my elbow and down to my wrist. It was painful to straighten my arm out fully. The tenderness finally started to go away when I received my second shot (28 days after my first shot). The tenderness was unnoticeable about 10-14 days after my second shot.
Patient experienced swelling and itching. Went to ER. Husband doesn't know tx she received.
4/17 Vaccination @ 530PM  4/18 woke up with stiff neck. Unsure if chest pain started on 4/18 or 4/19. Stiff neck felt like 'being choked'. 2 sharp pains in between breasts.  Little pains on left breast, worked up to neck and ear.  4/19 ER.  4/20 ER ultra sound 4/21 cardiologist cb to tell me I had a pulmonary embolism. The Dr. said I needed to go to larger clinic.  4/22 Larger Clinic. They ran some scans with contrast of neck because of pain.  CT.  Taking blood clot medication.  4/26/2021 Extremely dizzy; going to have a CT scan today  **dizziness is so bad right now.  *4/29 appt with pulmonologist
herpes zoster; post herpetic neuralgia; trigeminal neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered of herpes zoster, postherpetic neuralgia, and trigeminal neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers  and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient 's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the 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 outcome of the events of herpes zoster, postherpetic neuralgia, and trigeminal neuralgia was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of were considered to be disabling.
This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 15Nov2021 at 00:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an intramuscular route of administration in the left arm on 28Jan2021 (at the age of 24-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an intramuscular route of administration in the left arm on 18Feb2021 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 15Nov2021, the patient experienced headache, tiredness, fever, chills, nausea and pain and soreness at injection site. The events headache, tiredness, fever, chills, nausea and pain and soreness at injection site did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events headache, tiredness, fever, chills, nausea and pain and soreness at injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, tiredness, fever, chills, nausea and pain and soreness at injection site was resolving at the time of report. No follow-up attempts are possible. No further information is expected.
Around 7 at night I developed severe pain on site of injection. Then I developed chills, fever, I took Tylenol. I had a bad headache on the back of my head and neck. I used an electrical heating pad on my feet, then I developed a fever. Suddenly I woke up and vomited. I felt a little relief. Took Tylenol again.  I could not move well due to bad muscle aches and stiffness.  Site of injection pain is almost gone, but I am still feeling Ill.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 17Nov2021 as dose 3 (booster), single (Lot number: FH8939) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "recovering" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Antiviral details: Treatment start date 13Apr2022, treatment stop date 18Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
injection received Fri 9.16.22 approx 12:45 pm. That evening approx 7pm patient had pain at injection site--radiated to entire shoulder and arm. Site felt "puffed up" about 1/2 inch high and 2 inches across. Says  hurt to  touch or move arm,. Pain worse next day, but decreasing on Sunday. Day 4 (Mon) I saw arm-no redness or rash, no noticeable raised area at injection site (did not remove bandage), still has some pain, but feels much better. Never noticed any fever or other symptoms.
45 y.o. female with a hx with asthma, migraine, here for second dose vaccine. C/O feeling shivering, sweaty, and racing heart beats. Similar feelings with the first dose but much more mild. HR reports up to 120s. Check BP 144/109 HR 110 RR 18 --- > BP 135/91, HR 99-100 on discharge at 12:20 pm. Patient  rests comfortably and feels a lot better. She has no respiratory complain or cardiac complain on discharge. Walks away without apparent distress. Symptoms resolved
After the fifteen minute mark after receiving vaccine, he noticed swelling at his wrist near his right hand. It is unknown if that was already there before receiving the vaccine. No other marks or bumps or reactions aside from the swelling at his right wrist. Spoke with patient 45 minutes after receiving vaccine and he said the swelling has gone down, no new reactions.
Recurrance of symptoms and positive test on the home test; Recurrance of symptoms and positive test on the home test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 as dose 1, single (Lot number: FH8027) and on 06May2022 as dose 2, single (Lot number: FJ49489), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Recurrance of symptoms and positive test on the home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Recurrance of symptoms and positive test on the home test; Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received anti-viral medication which included Paxlovid (Lot number: 1910754A) for COVID-19 Treatment. Treatment started on 13Jul2022 and stopped on 18Jul2022.  Follow-up attempts are completed. No further information is expected.
Stroke requiring 911 call and subsequent hospitalization after ER visit. Heart arrhythmia after stroke and subsequent hospitalization after ER visit.
High fever started about 6 hours after receiving 2nd dose of the vaccine (no side effects other than mildly sore arm after 1st dose). In addition - severe headache occurred in the middle of the night and later for next 12 hours. The headache was so severe I could not get up from bed to walk to the bathroom - I was so weak on my legs I was concerned I will faint. Strong muscle pain - especially in the back. Basically I was knocked unconscious for almost 24 hours after I received the vaccine.
Varivax 6/23/2000.  Chicken pox illness 2/17/2006. 8 lesions mild illness.
Immediate swelling and edema that progressed to significant swelling in the area and extending into upper shoulder, anterior upper chest wall and axillary area. Noted on exam on 01Mar2021 to have a 2cm discrepancy when compared to her other arm with increased skin temperature and induration with non blanching erythema
worried it's appendicitis; have abdominal pain on the right side; This is a spontaneous report from a contactable consumer reporting for himself. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 05Apr2021 (at the age of 40 years old) as a single dose for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Apr2021, the patient started to have abdominal pain on the right side, 1 week after his second dose. The patient was worried it's appendicitis. The events resulted in a physician's office visit. The patient did not receive any treatment for these events. The outcome of the events abdominal pain and suspected appendicitis was not recovered. Since the vaccination, the patient had not been tested for COVID-19.   Information about Batch/Lot number has been requested.
patient "went down", hit his head, and got back up. Last ate 13:00. alert and oriented x3. no c/o injuries or discomfort, no obvious injuries observed.  vitals signs as follows: 13:24 hr- 79 resp- 18 bp-144/86 o2- 98% RA 13:29 hr 100 resp 18 bp- 122/80 o2- 99% @ RA 13:34  hr 83 resp- 18 bp-120/82 o2 @ 99% RA  patient released home by self.
4 month old infant given both PEDIARIX and PENTACEL at same visit. Should have given PREVNAR. Age of patient at time of event: 4 months. Age of patient at time of event: 4 months.
Five months after my second dose of the vaccine I was treated for a UTI in August but the tests were negative. Two months later I started to have Bladder Spasms and I was treated for a UTI even though the tests were negative. One month later I went to the urgent care because I had spasms and pain. I was positive for a UTI and received treatment again. None of the courses of antibiotics provided relief. I had a Cystoscopy in December and the tests were negative. I was prescribed medication for Bladder Spasms. Nothing was found. One month later I was still having a constant urge to urinate. One month later I passed a Bladder Stone and the pain improved. My urine stream was irregular before and now it is better. I feel recovered now without any urges or pain.
no other issues were reported; The patient received his 3rd dose of RECOMBIVAX HB on 03-FEB-2021 and it expired on 24-JAN-2021; This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 03-FEB-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) with expiration date of 24-JAN-2021 (dose, route, anatomical location and lot number were not reported) for prophylaxis. No other issues were reported.
1.25 inches redness, and localized swelling of R thigh at varicella injection site. Advised MOTRIN and cool compresses to site.
mom rpt she noticed 2 blister bumps on pt on evening of vax; 8 more cam on 7/29, fever 101, was irritable;
Pt called saying she received PNEUMOVAX yesterday and her (L) arm is hot and red and swollen from shoulder to elbow. Told to come in for check.
Report AE from second vaccine/Had and every other symptom on fact sheet; Pain in rib; Pain all the way pain down spine; Pain in Knee; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report AE from second vaccine/Had and every other symptom on fact sheet), MUSCULOSKELETAL CHEST PAIN (Pain in rib), BACK PAIN (Pain all the way pain down spine) and ARTHRALGIA (Pain in Knee) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 027L20A,) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery. Concomitant products included LORAZEPAM and ESCITALOPRAM for an unknown indication.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION COMPLICATION (Report AE from second vaccine/Had and every other symptom on fact sheet), MUSCULOSKELETAL CHEST PAIN (Pain in rib), BACK PAIN (Pain all the way pain down spine) and ARTHRALGIA (Pain in Knee). On 09-Feb-2021, VACCINATION COMPLICATION (Report AE from second vaccine/Had and every other symptom on fact sheet), MUSCULOSKELETAL CHEST PAIN (Pain in rib), BACK PAIN (Pain all the way pain down spine) and ARTHRALGIA (Pain in Knee) had resolved.            There was no treatment taken for symptoms Action taken with mRNA-1273 in response to the events was  not applicable    Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient age, gender, medical history entered. In products tab, first and second vaccination lot number, anatomical position and date of second vaccination updated. Concomitant Products updated. New events back pain, musculoskeletal chest pain, arthralgia, vaccination complication entered and outcome of events updated.
Patient began itching in about 4 hours. She broke out all over from head to toe. Took BENADRYL and rash went away.
A report was received from a health care professional on 10/18/2002, concerning a 39 year old female vaccinee who experienced pruritus 12 hours after receiving Fluvirin vaccine on 10/15/2002. On 10/15/2002, the patient experienced pruritus on her arm and abdomen. She self-medicated with Benadryl and the pruritus eventually resolved. The reporter has assessed the relationship of the vaccine to the event as probable. Update1. 04/01/2003: A report was received from a health care professional who indicated that the pruritus resolved on 10/16/2002. The vaccinee received the recomendation that she should not receive further vaccinations containing chicken, egg, or thiomersal. The reporter has assessed the relationship of the vaccine to the event as possible.
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 19-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Patient stated large knot formed above top of arm.  She stated the injection was give very high in the upper deltoid close to the top of the arm at the shoulder.  She stated she could feel the vaccine enter her upper shoulder area around the clavicle and closer to her neck.  The area is still very sore near her clavicle bone and knot is visible.
On 02/03/2023 I woke up with a fever, coughing and congestion. I went to urgent care on 02/04/2023 and I tested positive for COVID-19. The provider prescribed PAXLOVID. I still had pressure in my head and ears for several weeks.
1st dose of Shingrix received 7 years ago late for 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 7 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose of Shingrix received 7 years ago late for 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2023 The reporter did not have vaccination details for the first dose. The reporter did consent to follow up via postal mail. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
MINOR RASH AND TENDERNESS ON FRONT OF UPPER ARM. ASKED THE PATIENT TO TAKE BENADRYL, PATIENT IS FINE.