chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain on the back of the neck; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th February 2022, the patient received the 2nd dose of Shingrix (intramuscular). In February 2022, less than a day after receiving Shingrix, the patient experienced neck pain. The patient was treated with paracetamol (Tylenol) and acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the neck pain was not recovered/not resolved.   It was unknown if the reporter considered the neck pain to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in left arm and on date of reporting (16th February 2022) around 3:00 am, the patient experiencing pain on the back of neck. The patient stated the pain had been about the same, it had not gotten better or worse. The patient took Tylenol and Aspirin due to pain. The patient did not have lot/expiry date of Shingrix. The patient did not had any contact information, except health care professional's name and facility's name. The reporter consented to follow-up.
16NOV95 seen in ER for poss rxn to TD 13NOV95;large, warm, area of redness below inj site;rx DPH, Steroid
Debilitating effects from vaccine and booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster ), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "Debilitating effects from vaccine and booster"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "Debilitating effects from vaccine and booster". The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "Debilitating effects from vaccine and booster".  Additional information: Will not get any further vaccinations due to horrible effects from having Covid in 2020 & then with each vaccine & booster the debilitating effects lasted for 2-3 weeks (original Covid lasted 2 months for patient)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented with Rx for antibiotic and pain meds from PCP. He had rash on left arm (injection arm) and pain as well as swelling and limited mobility.
no adverse event; HCP called regarding GARDASIL 9. Caller stated vaccine had been administered to a 5-month-old. Caller was not able/willing to provide patient demographics. No reports of adverse effects from administration. Permission to contact HCP was given. No add; This spontaneous report was received from a nurse and refers to a 5-month-old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On 18-OCT-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). No additional AE/no PQC (No adverse event).
The vaccine expiration date was incorrect in the refrigerator, and the patient received an expired dose of Pfizer COVID-19 vaccine.
MUSCLE ACHES ALONG THE FRONT OF THIGHS; PAINFUL ARM AT THE SITE OF INJECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced muscle aches along the front of thighs, and painful arm at the site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches along the front of thighs and painful arm at the site of injection was not reported. This report was non-serious. This case, from the same reporter is linked to 20211124852.
Localized reaction of hives which appeared other areas than injection site. Onset of redness/swelling at time of injection, hives appeared 2 day later. Also lethargic, nausea, loss of appetite.
Pt. feels warm and dizzy with nausea.  Pt. thinks blood sugar is low. Blood sugar checked by EMT=106-water & fruit D/C'd home today (4/23/21) at 13:30 p.m.
Developed redness with a 6 inch round induration around site with obvious edges around 1/2 inch high same evening of injection. Entire upper arm became red and swollen. Left arm measured at 15 inches compared to right at 12 1/2 inches.  Arm was painful and difficult to move for several days.  At 3 days later, arm is no longer red but arm is firm/swollen but getting better
Health preadolescent given MENVEO in (L) arm on 9/28/10. On 9/29/10, developed erythema and swelling in surrounding area. When area was 8 1/2 x 10cm in size started diphenhydramine 25mg q 6 hours. Eighteen hour later (9/30) area more swollen and red (13 x 17 cm). Pt continued BENADRYL and started on Prednisone.
Patient presented to ED via EMS due to decrease oxygenation at home.  In the ED supplemental oxygen initiated.  Chest xray shows changes consistent with COVID-19 PNA.  Covid antigen positive, CRP elevated.  Patient reports frequent nonproductive cough, ongoing dyspnea, increased lower extremity edema.  Patient admitted to hospital and started on BiPap with oxygenation improvement.  Patient then was found to be unresponsive with Bipap mask off, code was called and patient went through 2 rounds of ACLS with 2 doses of epi with ROSC on ventilator, patient on epi drip and transfer to ICU.  Decision to withdraw care was made and patient passed on 9/13/2021.
Red swollen knot within an hour of getting shot and still have it 4 days later / Red, hot swollen, hard knot; Red swollen knot within an hour of getting shot and still have it 4 days later / Red, hot swollen, hard knot; Red swollen knot within an hour of getting shot and still have it 4 days later / Red, hot swollen, hard knot; Hurts to move arm and use that muscle; Hurts to move arm and use that muscle; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Feb2022 at 14:30 (Lot number: FU1614) at the age of 61 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Heart failure" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing), notes: High blood pressure; "Migraine" (unspecified if ongoing), notes: Migraines; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Egg allergy" (unspecified if ongoing), notes: Known allergies: Eggs; "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish; "Milk allergy" (unspecified if ongoing), notes: Known allergies: Dairy and "Fruit allergy" (unspecified if ongoing), notes: Known allergy: Tomatoes. Concomitant medications included unspecified blood pressure, cholesterol, heart and antidepressant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: BW0171; Administration Time: 13:00; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 09May2021, when the patient was 60 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: BW0153; Administration Time: 15:45; Anatomical Location: Left arm; Route of Administration: Unspecified), administration date: 09Jun2021, when the patient was 60 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE MASS (non-serious), all with onset 05Feb2022 at 16:00, outcome "not recovered", and all described as "Red swollen knot within an hour of getting shot and still have it 4 days later / Red, hot swollen, hard knot"; PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset 05Feb2022 at 16:00, outcome "not recovered", and all described as "Hurts to move arm and use that muscle". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site warmth, vaccination site mass, pain in extremity and myalgia.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
sepsis syndrome with encephalopathy, fever, leukocytosis. all cultures and CXR negative, no infection discovered
p/vax pt devel erythema multiforme;MD intended to hosp infant;pt vomited once per day every day for 3 days p/vax;fever of 101 ax erythema multiforme on the face, neck, chest & extremities;ecchymosis & peripheral edema;pt not hosp; Follow up: A report from lab(E98357-063A) regarding events. It was reported, "A physician reported that a 3 month old male received Rota Shield on 18-Dec-1998. On 22-Dec-1998, he developed erythema mulitiforme. The physician intended to hosptalize the infant. no further information was available at the date of this report(08/16/2002). Follow up information was received on 11-Feb-1999. The pt is a female who also received HIB (PMC France), DTP(PMC France), IPV(PMC France), and hepatitis B(Merck) vaccines. She vomited once per day ever day for 3 days following immunization. On 21-Dec-1998, she developed a fever of 101 degrees F(axillary) and erythema mulitiforme on the face, neck, chest, and extremities. On 23-Dec-1998, the rash progressed to confluent erythema multiforme with ecchymoses and peripheral edema. the infant was not hospitalized. She recovered. Follow up # 1 (2-Jul-1999) lot number reportes for DTP 0970140 corresponds to a lot number for DTAP-Tripedia. Follow up (08-Aug-2002) During internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added peripheral edema).
Immediately following the vaccine my arm was sore, hot and swelling started to occur. Throughout the day it got worse. The next day it was extremely painful, and hard for me to lift my arm. A rash was forming on the site of injection and injection point is yellow in color also extreme swelling. As of today May 26, 2021 I have a red rash patch approx. 4inches x3 inch on my right arm and a yellow dot where needle was injected. I feel fine, I can lift arm w/out pain,  swelling has gone down completely. Rash remains.
Pt recvd MMR vax on 07MAY90; On approx 17MAY90 pt exp cough, rash, & rhinitis;
Fever of 102 degrees, extended episode of chills and shaking,  fast heartbeat, weakness, loss of appetite, loss of taste, headache and loss of energy.
6/29/2021  Runny nose & eyes, 6/30 +post nasal drip and productive cough 7/1  +low grade fever,Jul 01, 2021 3:45 pm SARS-CoV-2 (PCR) Not detected.  7/3 fever gone, all others continue, took Mucinex every 12 hrs. 7/6 saw Dr. & got amoxicillin-pot clavulanate (Augmentin) 875-125 mg 1 tab 2x/day
Headache, Arthralgia, Fever, UrticariaPruritus, Sire pain, redness, swelling, chills Narrative:
This spontaneous report was received from a medical assistant and refers to nine unspecified patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of VARIVAX lot # M009766 with an expiration date: 23-FEB-2018, subcutaneously (dose and frequency were not reported). Administered dose of VARIVAX experienced temperature excursion of 6.2 degree Fahrenheit for 14 hours 28 minutes, on 02-AUG-2016; 6.2 degree Fahrenheit for 13 hours and 45 minutes on 05-AUG-2016; 6.2 degree Fahrenheit for 14 hours and 10 minutes on 11-AUG-2016, 6.2 degree Fahrenheit for 13 hours and 59 minutes on 22-AUG-2016, 6.2 degree Fahrenheit for 61 hours and 50 minutes on 29-AUG-2016. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Psoriasis aggravated/skin was cracked all over and he had blood spots on it; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (Psoriasis aggravated/skin was cracked all over and he had blood spots on it) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) injection for Psoriasis vulgaris.    No known allergies were reported.  Concurrent medical conditions included Psoriasis vulgaris. Concomitant products included IBUPROFEN for an unknown indication.   On 24-Jun-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis aggravated/skin was cracked all over and he had blood spots on it). At the time of the report, PSORIASIS (Psoriasis aggravated/skin was cracked all over and he had blood spots on it) outcome was unknown.     It was reported that patient's psoriasis vulgaris got worsened two weeks after he received the moderna vaccination. When he had taken off his shirt the skin was skin was cracked all over and he had blood spots on it. Patient stated that it was getting embarrassing when had to go out. It was unknown if the patient was enrolled in a covid-19 vaccine trial.  The reporter's causality for Skyrizi(risankizumab) for the event of psoriasis vulgaris worsened was not provided.  No treatment medication was reported.
Expired vaccine (6/30/23) was given from the '22-'23 flu shot season. No ADRs occured.
PM after vaccines, prolonged crying, screaming. Vomited, arching back unable to calm down - 6+ hours
This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not known. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (strength, dose and frequency were not reported, lot # L030871, expiry date: 10-JUN-2018). No adverse events were reported. No further information was provided. Product quality complaint was not filed. This case is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt devel cellulitis;the hosp tx w/oral & injectable ATB & recovered;
Aches and chills beginning nine hours after second vaccination, headache and  dizziness beginning about 12 hours after vaccination.  All this continued for 36 hours.  Feeling much better now almost 48 hours after injection, but still only about 75%.  I did not take any analgesics.
Almost immediate pain in area of injection. Pt states was a 10/10 for one week. Has taken ALEVE PRN. Still cannot raise left arm fully. Suspects was given too high on left arm. Limiting use, pain with use of arm. No prior history of any problems with left arm or shoulder.
breast cancer; This case was reported by a pharmacist via call center representative and described the occurrence of breast cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th June 2019, the patient received the 1st dose of Shingrix. In September 2019, less than 3 months after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In the week of date of reporting, the patient was diagnosed with breast cancer. The reporter consented to follow up.
Tinnitus after the first shot - went away in a few days Constant Tinnitus after the second shot, it's heavily affecting my sleep and ability to concentrate. Fatigue, Dizziness Swollen Lymph nodes - on left arm, it was the size of half an egg. Lymph nodes are smaller after 6 weeks but still sensitive.
Pt administered flu vaccine on 10/20/15 with new symptoms of (L) shoulder pain/limited range of motion since.
The left side of my face, from my ear to my cheek went a little numb and tender to touch.
Pt had a positive covid result in January of 2022. Pt had mild symptoms during 10 day isolation but has developed chronic illnesses post-covid. Chronic illnesses include: Asthma, sleep apnea, and possible enlargement of aorta.
Patient received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergy/reaction and concomitant medication were not reported. On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, frequency, route were unknown) lot # S007075, expiry date: 06-SEP-2020 for prophylaxis. On an unknown date, the patient recived improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) vaccine (product storage error). The outcome of product storage error was unknown.
This spontaneous report was received from a pharmacy intern referring to a 57 year old female patient. The patient's concomitant medications, medical history and drug reactions/allergies were reported as none. On 13-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, administered subcutaneously in the back of her left arm (lot # M035696 with and expiration date of 07-NOV-2017; strength was not provided), for prophylaxis (reported as recommended age for vaccination). On the same date, about 5 minutes after vaccine administration, the patient developed a 2 inch red rash at the site of vaccination. Then, in the evening, the rash spread 6 to 8 inches. On an unknown date in May, the rash became red, swollen and formed into a welt. In addition, the patient continued to have muscle aches for the a few days. It was reported that the patient did not seek medical attention. Laboratory diagnostics studies were not performed and the patient did not received any treatment for the events. On 23-MAY-2017 (reported as within 10 days of vaccination), the patient recovered from the vaccination site rash, vaccination site urticaria, vaccination site swelling and vaccination site erythema. The causal relationship between all above mentioned events and ZOSTAVAX was not reported. Additional information has been requested.
Developed enlarged lymph nodes along back of head, along clavicle (largest one), and sides of neck.  Severe fatigue, fever X 4 days.  Lymph node along clavicle remains somewhat swollen.
Dizzy; Erratic heart rate; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy) and HEART RATE ABNORMAL (Erratic heart rate) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (almost to every antibiotic). Concomitant products included B-COMPLEX + VITAMIN C for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (Dizzy) and HEART RATE ABNORMAL (Erratic heart rate). On 21-Jan-2021, DIZZINESS (Dizzy) and HEART RATE ABNORMAL (Erratic heart rate) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 110/60 (normal) 110/60 on average. On an unknown date, Heart rate: 62 (normal) resting heart rate in bed is 62 beats per minute, 72 (normal) when moving around is usually about 72 beats per minute and When it (heart rate) was erratic it ranged from 40-83 beats per minute.     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.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Followup received on 31-mar-2021. NNI
A few days after receiving PREVNAR 13, pt experienced fever, body aches, not chills. Arm soreness. Fever up to 101.6 (self), and fevers up to 100 persisted for a few days.
*:15 pm-IM deltoid ENGERIX-B given-immediate complained of being lightheaded, was diaphoretic-continued seated on cool room. 3:20pm-stated feeling better-reported for work duty. 3:45 am-dizzy, diaphoretic, severe headache, flushed, nausea. 4 pm-onset of double vision-right eye turned inward, tingling of fingers and tip of tongue-transported by ambulance to ER.
When vaccination was being conducted, the entire dose of 0.5 cc ran down his arm. After consulting with agency doctor, he ordered that a full dose be administered.
SWELLING IN LEFT ARM AT THE INJECTION SITE; REDNESS AT INJECTION SITE; HURTING AT INJECTION SITE; RASH ON LEFT ARM AT THE INJECTION SITE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced redness at injection site. On 08-MAR-2021, the subject experienced hurting at injection site. On 08-MAR-2021, the subject experienced rash on left arm at the injection site. On 09-MAR-2021, the subject experienced swelling in left arm at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever, and had not recovered from redness at injection site, hurting at injection site, rash on left arm at the injection site, and swelling in left arm at the injection site. This report was non-serious.
Tenderness, itching, redness, swelling.  Itching & a 10 centimeters lump still present after 9 days