chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a paper and poster presented at the Conference on Vaccine Research. Four real-time polymerase chain reaction protocols were used to target four vaccine-associated single-base polymorphisms, allowing the identification of VZV-positive specimens and discrimination of vaccine from wild-type VZV strains. Cerebral spinal fluid samples were sent to the CDC for genotyping. Additional clinical information was requested for the 26 cases that were successfully genotyped. Patients ranged in age from 12-85 years (median 46.5): seven (27%) were years of age. Eight were immunocompromised (30%). Eleven (42%) had rash: 9 (35%) were described as zosteriform. Median CSF white blood cell count was 267 cells/mm3 (range: 6-1615), median CSF protein level was 96 mg/dl (mg:17-239) and median CSF glucose was 59 mg/dL (range: 24-79). Of the seven pediatric cases, 6/7 were immunocompetent, four had a history of at least one dose of varicella vaccine, two had a history of disease, and one was unimmunized. Genotype analysis identified: 20 foreign strains; four foreign strains, one of which was the vaccine strain; and two foreign strains. This report includes the fourth documented case of VZV vaccine strain associated with CNS disease, presenting 11 years post immunization [with] meningitis and herpes zoster rash. This strain was found in a previously healthy 12-year-old girl, who presented with meningitis symptoms. These results suggested that varicella-zoster virus continues to be associated with CNS disease, including reactivation of vaccine virus. Upon internal review, meningitis was considered to be an other important medical event. No further information available. No further information available.
Mother states child broke out in rash that started on her face and then proceeded to cover entire body, mother reports child running temperature with rash outbreak. Mother states she has not seen a PCP, but has kept the child at home and has been giving child PRN Acetaminophen for temperature control. Child is reportedly managing well. Advised client's mother to keep child away from anyone who is immunocompromised has not received Varicella vaccine and would be at risk for developing disease until rash is scabbed over, if s/s worsen to always contact PCP.
Developed seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 (Lot number: ER8733) at the age of 21 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing); "Type 1 Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. There were no known allergies. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The following information was reported: SEIZURE (medically significant) with onset 11Apr2021, outcome "not recovered", described as "Developed seizures". The event "developed seizures" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: unknown results; magnetic resonance imaging: unknown results. Therapeutic measures were taken as a result of seizure. The patient received unspecified treatment for the adverse event.
I had a nasty reaction to 2nd dose of Moderna 8-12 hours after. Began with body aches and chills so severe it was hard to breath. No fever. When I got under covers and warmed up so chills subsided and breathing returned to normal it felt like I was being squashed in a Panini press. Every cell in my body felt like it was vibrating in pain. I had to get up ever hour or so to urinate. I would be back in sever chill mode before i made it to the bathroom and it took about 5 minutes back in bed for chills to stop and breathing back to normal. I was also nauseous the whole time but did not vomit Then. The room temperature was 72F. This continued for 12-14 hrs.  I then tried to drink cranberry juice and eat 3 bites of a banana which  I immediately regurgitated. The rest of the day I was drained of energy. No sleep 48hrs. 3 days
Developed rash 2 days post injection at site. Also reported bloody nose & elevated BP. Continued elevated BP x 1 week & saw PCP. BP eventually normalized.
Client presented for booster vaccination.  Nurse reviewed the list of clients needing a booster and Registration form and vaccinated client with Moderna booster.  After already giving, booster, the nurse again reviewed the paper indicating clients who needed booster.  The booster for this client was due 3/18/21 (year written wrong) and didn't think about the fact it should have been 2022.  She understands she will need to slow down next time and be sure of dates before vaccinating.
Feels warm; Could not sleep straight because every 2-3 hours he will wake up with his leg pain; flushed; pain on his legs but mostly on his right leg; Legs jerks and it will cause pain again; Pain round the ankle going up to the legs; right arm is very itchy; Right arm is painful; veins on his both legs looks swollen; Veins on his both legs very painful to touch,; Limping/can hardly stand on his feet at the time of the call; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (right arm is very itchy), VACCINATION SITE PAIN (Right arm is painful), VASODILATATION (veins on his both legs looks swollen), VASCULAR PAIN (Veins on his both legs very painful to touch,) and GAIT DISTURBANCE (Limping/can hardly stand on his feet at the time of the call) in a 79-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.     Concurrent medical conditions included Food allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced PRURITUS (right arm is very itchy), VACCINATION SITE PAIN (Right arm is painful), VASODILATATION (veins on his both legs looks swollen), VASCULAR PAIN (Veins on his both legs very painful to touch,), GAIT DISTURBANCE (Limping/can hardly stand on his feet at the time of the call), DYSKINESIA (Legs jerks and it will cause pain again) and ARTHRALGIA (Pain round the ankle going up to the legs). On 17-Aug-2021, the patient experienced FEELING HOT (Feels warm), INSOMNIA (Could not sleep straight because every 2-3 hours he will wake up with his leg pain), FLUSHING (flushed) and PAIN IN EXTREMITY (pain on his legs but mostly on his right leg). At the time of the report, PRURITUS (right arm is very itchy), VACCINATION SITE PAIN (Right arm is painful), VASODILATATION (veins on his both legs looks swollen), VASCULAR PAIN (Veins on his both legs very painful to touch,), GAIT DISTURBANCE (Limping/can hardly stand on his feet at the time of the call), FEELING HOT (Feels warm), INSOMNIA (Could not sleep straight because every 2-3 hours he will wake up with his leg pain), FLUSHING (flushed), PAIN IN EXTREMITY (pain on his legs but mostly on his right leg), DYSKINESIA (Legs jerks and it will cause pain again) and ARTHRALGIA (Pain round the ankle going up to the legs) outcome was unknown.            patient took vitamin C as concomitant medication and also  mentioned that took his first dose on 12-JUL-2021 and experienced some events. No treatment medications are provided by reporter.   This case was linked to MOD-2021-291444 (Patient Link).
Post needle stick, pt recvd 3 doses of Engerix-B given 27FEB91, 3APR91 & 27AUG91 & on 27FEB91 recvd HBIG also 18OCT91 pt had no titer; 2 more doses of vax will be given;
Approximately 45 minutes after injection, had numbness and tingling to face, nose, lips, right arm felt "heavy", had increased heart rate, felt "clammy and sweaty." Symptoms lasted 3 hours. Has had similar reactions to Cortisone shots and allergy shots.
Mom reports that the day following the vaccines he had a small circular area of redness and swelling but the next day he woke and he had an area 7"x5" of redness, swelling, slightly firm to touch and warm. The area of redness was marked. He was seen back at the clinic and family was advised to use Ibuprofen 5 tsp every 6-8 hours as needed, BENDRAYL 3 tsp every 6-8 hours as needed, apply ice to the area and the physician did call in some KEFLEX for 5 days. Family is to follow up by phone on Saturday sooner in the office if things are worsening.
Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.   On 23-DEC-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L034724, expiration date 09-DEC-2016) (strength and dose were not reported) subcutaneously for prophylaxis. No side effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014176:
improperly stored vaccine administration; This spontaneous report was received from an unspecified reporter and refers to a currently 4-year old patient of an unknown gender. Information concerning the patient's past medical history, concurrent conditions, concomitant medications and historical drugs/allergies was not provided.   On an unspecified date, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) 0.5 milliliter, lot # T005406, expiration date 12-AUG-2021 (frequency and route of administration were not reported) as prophylaxis  . The improperly stored suspect vaccine experienced a temperature excursion of - 9.5 Celsius degrees (C) for 8 hours and 53 minutes, and -10.1 C for 6 hours and 40 minutes as recorded by a digital data logger. No previous temperature excursion was reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2009USA008533: US-009507513-2009USA008520: US-009507513-2009USA008398: US-009507513-2009USA008449: US-009507513-2009USA008475: US-009507513-2009USA008486: US-009507513-2009USA008553: US-009507513-2009USA008555: US-009507513-2009USA008557: US-0095075132009USA008761:
Had vaccine in Tuesday AM - Later in day had tingling in fingers of (R) arm and by the next day her entire arm felt numb. By Friday, her arm was also hurting so she saw physician who put her on anti-inflammatory meds. Next week continued to have problems with numbness and tingling so doctor put her on muscle relaxant, something for nerves and exercises.
within first 24 hours had expected reaction of chills, and flu like symptoms, but 9 days later face became swollen and right arm was swollen as well . MD treating with course of prednisone and she is improved .  now states that after first dose she had a rash on her chest that she never shared with clinic staff at second appointment
AFter first dose, when I was working and wearing N95 mask I was sweating profusely and feeling overheated.  I ascribed it to my job, however, I would feel these symptoms at home too off and on.  After the second dose, the day after, I had flu like symptoms which subsided in 24 hours.  However, I feel overheated all the time and sweating.  I need to sleep with my blankets off and the windows open to not feel overheated.  It's not a feeling of fever or chills, its more like hormonal or something.  I'm drinking ice cold drinks to keep me feeling cooler.  Anyways, hopefully, it will go away.
At first I has some injection site pain and soreness nothing too bad. But around 01:30 I awoke with a really high fever. My fever was 102.8 when I first woke up. I was very nauseous and my fever felt worse. My thermometer would not read any more until my temp came down. I can only guess how high it got but at least 103 degrees. I took Advil Liquid Gells and then my fever broke. I was actually scare for my life. In March I actually caught coronavirus and developed  anti bodies for Covid. I can only guess my body was fighting for it's life.
This spontaneous report was received from a registered nurse, concerning a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-DEC-2018, the patient was vaccinated with M-M-R II, for prophylaxis (dose, lot number and expiration date were not reported). The reporter stated that the vaccine was accidentally administered intramuscularly instead of subcutaneously (incorrect route of product administration).
the muscle pains worsened in a disabling way; ruined my hair almost went bald; the nails of my feet and hands were split in half; my bones also hurt me as they had never hurt me; they dream me terrible; depression; anxiety; internal heat of my body is unbearable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (disability), outcome "unknown", described as "the muscle pains worsened in a disabling way"; ALOPECIA (non-serious), outcome "unknown", described as "ruined my hair almost went bald"; ONYCHOCLASIS (non-serious), outcome "unknown", described as "the nails of my feet and hands were split in half"; BONE PAIN (non-serious), outcome "unknown", described as "my bones also hurt me as they had never hurt me"; NIGHTMARE (non-serious), outcome "unknown", described as "they dream me terrible"; DEPRESSION (non-serious), outcome "unknown"; ANXIETY (non-serious), outcome "unknown"; FEELING HOT (non-serious), outcome "unknown", described as "internal heat of my body is unbearable".  Clinical course: Patient reported that "vaccine ruined my hair almost went bald the nails of my feet and hands were split in half, the muscle pains worsened in a disabling way and my bones also hurt me as they had never hurt me and they dream me terrible, it gives me depression and anxiety constantly and the internal heat of my body is unbearable, the famous COVID vaccine that you took out was the worst thing that happened to me in my life and the worst thing they put me 2 ob".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Pt developed swelling, erythema and mild tenderness over 3 days. He was treated with Benadryl.
Bollus pemphigoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 82-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: EW0202), administration date: 26Oct2021, when the patient was 81-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: ER2613), administration date: 09Mar2021, when the patient was 81-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6200), administration date: 26Feb2021, when the patient was 81-year-old, for Covid-19 Immunization.  The following information was reported: PEMPHIGOID (medically significant) with onset 08Apr2022, outcome "not recovered", described as "Bollus pemphigoid". The event "bollus pemphigoid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of pemphigoid.  The course of the event: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Taking medications, unsure name of which one. What treatment received for the adverse event? Dupixent and some steroid pills. Prior to vaccination, was the patient diagnosed with COVID-19? No. Since the vaccination, has the patient been tested for COVID-19? Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
2 days p/vax pt exp inj site rxn of swelling,pain & warmth
Patient claims that his arm began becoming swollen shortly after vaccination but worsened the next day. He went to the ER on 10-10-20 and was admitted to the hospital for cellulitis. He stated that he is still on antibiotics for the infection.
Initial report received on 27 August 2012 from an investigator. A male subject (age not reported) was found to have an elevated troponin level (Rapid Troponin I level reported as within normal limits (Negative) and an elevated central laboratory (lab) Troponin I level result of 0.14 ng/mL) on 27 May 2010 (with reported date of 01 June 2010) after receiving an injection of ACAM2000, SP Biologics Co., (lot number, route and site not reported) on an unspecified date. Central laboratory Troponin level results were reported as less than < 0.10 ng/mL, "repeat test normal", according to Investigator, on 18 June 2010. ECG was reported as normal on 18 June 2010. Treatment reported as none. The subject had a past medical history of current foot pain and shin splints and nasal congestion, stuffy nose, and coughing on 20 May 2010 screening visit (reported as "no" on follow-up visit on 27 May 2010). Surgical history, use of topical steroids, and drug allergies were reported as "no". Screening visit on 20 May 2010, reported concomitant medications ALLEGRA taken since February 2010 for nasal congestion and Naproxen taken since February 2010 for shin splints (concomitant medications reported as "no" on follow-up visit 27 May 2010). The subject admitted to consuming alcohol two drinks a month, or less, and denied tobacco use. The stop date of adverse event elevated troponin was 18 June 2010. The subject recovered (also reported as "no residual effects") on 18 June 2010. According to the investigator the event of elevated troponin was possibly related to the trial product or the trial procedures. This represents a case of potential myopericarditis per the Investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: Medical Records.
Arm redness, swelling ,  induration, tenderness, pruritis. Symptoms began 1 week after injection. Associated with redness, swelling, and itching of ears.
Shingles was all internal (no rash/blisters).; Worst pain I've ever experienced! pain turned into stabbing; nerve band was so terribly swollen; This case was reported by a consumer via interactive digital media  and described the occurrence of shingles in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 60 days after receiving Shingles vaccine, the patient experienced shingles, pain and local swelling. On an unknown date, the outcome of the shingles and local swelling were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain and local swelling to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The patient stated that, he/she took a medication known to increase the risk, but despite appeals based on manufacturer recommendation and medical necessity, insurance still refused to cover the vaccine until the patient turned 50 year old. The patient got first dose few days after he/she hit 50 years, and 60 days later patent had a shingles. The patient experienced worst pain, it felt like someone was ripping his/her rib cage out the body with their bare hand, as it crept around from front to back, the pain was turned into stabbing. Seven weeks later, the patient still had pain but its much less severe. The patient stated that, it was all internal (no rash or blister), the nerve band was so terribly swollen it stuck out from patient's ribs. The patient would receive second dose tomorrow on 23rd August 2021 and hope it never happens again.
vaccination failure; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4420185-00.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), on 14Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 03May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 03May2022, outcome "recovered" (2022), described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 03May2022, outcome "unknown", described as "vaccination failure". The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "vaccination failure" and "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
PT IS STATING HAVING HIVES DEVELOPING FROM UNDER ARMPITS ALL THE WAY TO GROIN AREA.
This spontaneous report as received from a pharmacist refers to his 59 year old wife with penicillin allergy, lupus and seasonal allergies. The patient had a "physical examination and blood work" performed on an unspecified date before receiving ZOSTAVAX and "everything was fine other than an indication of high cholesterol". On approximately 03-MAY-2013, "about 6 weeks ago in early May", the patient was vaccinated with ZOSTAVAX. Concomitant therapy included ZYRTEC. The pharmacist reported that the patient "did not have any symptoms" however when she returned to the unspecified physician's office for a routine "physical examination and blood work" on 10-JUN-2013, her blood work showed "elevated liver enzymes". The pharmacist reported that the unspecified physician then performed "further studies and test" and "made an appointment for the patient" with an unspecified rheumatologist. The patient had not been seen by the rheumatologist as of 14-JUN-2013. The pharmacist reported that the patient "is doing fine except that she is very tired". No treatment was given. The patient was no recovered from events at reporting time. Additional information is not expected.