chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative concerning an approximately 75 year old female patient. Approximately on an unknown date in 2007 (reported as sometime at the end of 2007 or 2008), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. On 14-OCT-2013, the patient developed shingles on the right side of the neck after the vaccination. The patient sought medical attention (doctor visit). The patient was given unspecified medications. It was unspecified if any lab tests were performed. The patient was recovering from shingles on the right side of the neck. The relatedness for shingles on the right side of the neck was unknown for ZOSTAVAX. Additional information has been requested.
Chills; Body ache; Vomits; Low monocytes; Low lymphocytes; This case was reported by a nurse via call center representative and described the occurrence of chills in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, general body pain, vomiting, monocytes decreased and lymphocyte count decreased. On an unknown date, the outcome of the chills, general body pain, vomiting, monocytes decreased and lymphocyte count decreased were unknown.   It was unknown if the reporter considered the chills, general body pain, vomiting, monocytes decreased and lymphocyte count decreased to be related to Shingrix.  Additional details were reported as follows: This case was reported by a nurse. The age at vaccination was not reported. The nurse reported that the patient experienced vomits,body ache and chills after receiving Shingrix. Nurse also reported that patient had llow monocytes and low lymphocytes. Consent to follow.
Vaccine given IM using 25g, 1 inch needle into (L) deltoid, needle was withdrawn and area bled, bandage was applied, area immediately began to swell and turn red, Dr. was notified, bandage was removed and wiped with alcohol pad, area had stopped bleeding so bandage was left off, pt was observed for 15 minutes, redness measured 5.4 mm x 4.8 mm, swelling measured 4.5 mm x 3.5mm x 0.3mm, pt advised to apply cold compress and call or RTC if worsening symptoms or concerns.
Rash is a bit itchy; Shedding skin in big flakes; Bright pink rash shoulder to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Rash is a bit itchy), SKIN EXFOLIATION (Shedding skin in big flakes) and RASH (Bright pink rash shoulder to shoulder) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Rash is a bit itchy), SKIN EXFOLIATION (Shedding skin in big flakes) and RASH (Bright pink rash shoulder to shoulder). At the time of the report, PRURITUS (Rash is a bit itchy), SKIN EXFOLIATION (Shedding skin in big flakes) and RASH (Bright pink rash shoulder to shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included Steroid cream.
Cold sweats, joint pain, headache, sleepiness, nausea, vomiting.
Tue Nausea and Headache 15 or so minutes after shot same evening severe shivering Wed Next day tired, drifting off to sleep a lot First noticed hives about 4 pm when I was getting ready to shower
pt recv vax @ noon, had urticaria by 7pm & collapsed @ 8pm; difficult breathing, rash on arms, bumps on lip, blacked out;ER by 8:45pm, had BP of 75/44, pulse 90, resp 24;anaphylactic shock; placed on telemetry, cardiologist consult;Annual follow up states the pt has recovered.
It started with throwing up in the morning occasionally. To having the nausea and vomiting episodes at least 3 or 4 times a week. I have lost weight unintentionally, 34 lbs. I am below my BMI right now. But still have no appetite either.  I am having problems with my short term memory. And I am EXAusted all the time.
fever (38.5 degrees Celsius); chills; headache; This is a spontaneous report from a contactable physician (patient's parent). A 12-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), intramuscular, administered in the left arm on 09Jun2021 at 07:30 (Lot Number: EW0186) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient previously received the first dose of BNT162B2 (lot number: EW0179), intramuscular on 18May2021 at 07:30 on the left arm for COVID-19 immunization. On 09Jun2021 at 19:30, 12 hours after receiving the vaccine, the patient started having chills, headache and fever (38.5 degrees Celsius). Ibuprofen 300 mg was taken once. The following morning, 10Jun2021 around 9:00, another dose of Ibuprofen 300 mg was taken. The events resolved 14:00 on 10Jun2021.   No follow-up attempts are possible.  No further information is expected.
I am not sure the symptoms are directly related to the vaccine but did begin after the vaccine;  I have been experiencing severe numbness, weakness and tingling in my arms and legs since about a week after receiving the 2nd dose. Although I did go to the doctor in July  due to my concern about the symptoms, at that time I didn't mention it beginning after the vaccine, only that it had been occurring for a few months. It wasn't until after I returned home I realized that 'a few months ago" was after my 2nd shot.
1215AM pt's mom states felt needed to check on pt; shook arms & legs; felt limp like there was no life; picked pt up & put on shoulder & rubbed back & patted pt & pt took a deep breath; It took about 2 minutes for pt to really wake up;
48hr post vax temp 103.5, diarrhea, cranky, not sleeping well lasting x 2 days;called MD;
Onset of hives within couple hours of having second HPV vaccine, first on abdomen, then spreading throughout, somewhat itchy, but no resp symptoms. Developed additional and different hives the next day and some finger swelling, again no resp or GI symptoms. Able to drink and eat normally. On 14 Apr seen in primary care and in ER on 15 Apr when sxs did not resolve with BENADRYL. Given DECADRON IM in ER. No other exposures identified such as foods, chemicals, inhalations, or illness that might have caused the hives.
Information has been received from a registered nurse concerning a 12 month old male patient who on 09-NOV-2010 was vaccinated IM in the right thigh inadvertently with a dose of PNEUMOVAX 23 (Lot# 663997/0622Y). The nurse stated that it was a staff err; they grabbed the wrong vaccine. No adverse effects were reported. Follow up information was received concerning a 12 month old female (previously reported as male) patient with no pertinent medical history who on 09-NOV-2010, at 2:30 pm, was vaccinated IM in the right thigh inadvertently with a dose of PNEUMOVAX 23 (Lot# 663997/0622Y). Wrong vaccine was given. There were no illnesses at the time of vaccination. No adverse events reported. No further information is available.
Patient received 2nd dose of Moderna vaccine 14 days early.  First dose was administered on 4/15/2021 and second dose was administered on 4/19/2021. The patient started having fever and fatigue on 4/20/2021, but resolved within 24 hours. No other reactions noted.
Sore arm; Flu like symptoms; too tired; Fever off and on; Vertigo; Severe fatigue/chronic fatigue; scary; Dizzy spells; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Sore arm"; INFLUENZA LIKE ILLNESS (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Flu like symptoms"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "too tired"; PYREXIA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Fever off and on"; VERTIGO (non-serious) with onset Mar2021, outcome "not recovered", described as "Vertigo"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "Dizzy spells"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Severe fatigue/chronic fatigue"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "scary".  Additional information: Additional information: The reporter stated that the symptoms were coming and going but seemed to be getting more frequent and persist for longer periods, getting worse rather than better and patient never had these symptoms prior to the vaccination. Prior to the second vaccine the patient was doing fairly rigorous workouts, walking and biking daily. The patient was too tired to go for just a walk at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed an erythematous rash, somewhat raised, in left shoulder, in MMR vaccine site. It felt warm, per mom. No fever. Minimal itching, one day after administration. Treatment Benadryl. Measured 3cm x 5cm.
p/vax pt crabby all day;child is breaking out in a hive type rash all over body w/a raised welt type area on neck;c/o itchiness;dx as hives;
swollen @ arm, fever last noc t101.6; localized on @ arm red about 1 1/2" around; APAP & cool compress used;
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from an-other health professional. This case is linked to cases 2018SA271980, 2018SA271981, 2018SA271976 and 2018SA271983 (Same reporter). This case involves a patient (age range reported as 16-68 years old) (gender not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ011AG and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on 25-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccines were in transit to long. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This spontaneous report as received from a registered nurse refers to a 19 year old patient. In 2013 when the patient was 16 years old he was vaccinated with GARDASIL at his pediatricians office. He then did not received the second dose until April 2016 at the reporters office and then 3rd dose on 07-JUL-2016 intramuscularly. The nurse stated the patient is healthy with no known allergies and no adverse effects from the GARDASIL administration. No other information was provided. Additional information has been requested.
Mom states that the baby started crying from 4:30 pm through 8:00 pm. Tylenol had been given before administration of vaccine and every 4 hours after. The MD was called and advised Ibuprofen to be given. Mom denies fever or site soreness of legs. Crying resolved post ibuprofen.
UNEVALUABLE EVENT (SIDE EFFECT OR COVID VACCINE WAS LITTLE ROUGH); This spontaneous report received from a patient concerned a 62 year old female. 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, intramuscular, batch number was not reported) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab.  On 20-MAY-2021, the subject experienced unevaluable event (side effect or covid vaccine was little rough). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unevaluable event (side effect or covid vaccine was little rough) was not reported. This report was non-serious.
5 mins p/vax pt was sweaty & pale; BP 70/52, P70's pt given Adrenalin;
had "flu-like symptoms" for 2 days and they resolved after 1st dose; This case was reported by a physician via sales rep and described the occurrence of unexpected therapeutic drug effect in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Illness at time of vaccination included influenza-like symptoms.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic drug effect to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient had flu-like symptoms for 2 days and they resolved on their own after the patient received first of vaccine, which led to unexpected therapeutic drug effect. The reporter thought it was related to the vaccine.
Pt described feeling clammy, sweaty, having a sore throat, ear pain, and numbness in arm
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant medications was provided. On unknown dates since 06-MAR-2017, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot # M040141, expiration date: 27-MAR-2018, albumin status: recombinant human albumin (rHA); lot # M036158, expiration date: 12-FEB-2018, albumin status: rHA; lot # M014301, expiration date: 22-SEP-2017; albumin status: rHA; exact doses and route of administration were not reported). Vaccines were reconstituted with well-stored MERCK STERILE DILUENT. The reporter stated that the administered doses of PROQUAD were stored at temperature between 15 to 46 degrees Fahrenheit (F) for 9 hours on unknown dates. Data logger was used to detect temperature excursions. There were no previous excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA015652.
October 20 10:00 am c/o swollen lymph nodes under left arm, general discomfort under the arm, it hurt to have arm in resting position. No redness, warmth or pain at the injection site, no fever, no chills.
Dose 1: OCTOBER: 2019 Dose 2:06/9/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 3PD3E, expiry date 8th October 2022) for prophylaxis.   Previously administered products included shingrix (In October 2019, 1st dose received with batch number 4797C and expiry date 26th January 2022).   On 9th June 2021, the patient received the 2nd dose of Shingrix. On 9th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter was a registered pharmacist manager.. The patient received 2nd dose delayed than the recommended schedule, which led to lengthening of vaccination schedule. The reporter would like to know if a 3rd dose was needed. The reporter consented to follow up. This case had been linked to the case US2021125159, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021125159:same reporter
This case was reported by a physician via sales rep and described the occurrence of autoimmune disorder in a adult patient who received SHINGRIX for prophylaxis. The patient had a Family History of autoimmune disorder (it was runs in patient's family and might be unrelated). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 91 days after receiving SHINGRIX, the patient experienced autoimmune disorder (serious criteria GSK medically significant) and herpes zoster. On an unknown date, the outcome of the autoimmune disorder and herpes zoster were unknown. It was unknown if the reporter considered the autoimmune disorder and herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The patient was a nurse. The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient got zoster within a week of vaccination. Three months after vaccination, the patient developed an autoimmune condition. The patient was also reported that to VAERS. This case has been linked with case US2019AMR084173 and US2018GSK096361, reported by the same reporter.
Headache, Fever,  sweating, chills, body, nasal congestion  Narrative:  Employee reports symptoms are improving today on 4/21/21 and believes he will be able to RTW on 4/22/21.Employee verbalises understanding symptoms experienced are within the expected reactions, however if symptoms persist>48 hours or worse, F/u with pcp/medical attention for medical concerns/attention. Seek emergency attention with acute changes or concern.
This spontaneous report as received from a medical assistant refers to a 11 years old child, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported). Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient is fully vaccinated.  COVID + 1/13/2022 at ED visit. 57-year-old female who presents emergency center for evaluation of shortness of breath and cough.  Patient states that she has been experiencing shortness of breath intermittently for the past month but states that this is been worsening over the past several days. Patient denies any fevers or chills.  Patient denies any chest pain.BP (!) 189/96  | Pulse 103  | Temp 98.5 °F (36.9 °C) (Oral)  | Resp 24  | Ht 162.6 cm (5' 4")  | Wt 78.5 kg (173 lb)  | LMP  (LMP Unknown)  | SpO2 94%  | BMI 29.70 kg/m² Medications given:  steriods, tessalon. CXR: No acute pulmonary process. Stable and discharged home.
Pt recv vax on 12/9/98; on same day pt exp red neck & face w/ itching of head & arms, thick mucus, swollen upper arm w/ pain; tx=Benadryl
Patient reported that a little over 1 week after the vaccine, she had a horrible migraine over the weekend and experienced nausea. She also was very fatigued. The patient had no side effects aside from sore arm during the first week after vaccination.
Patient's arm became very red following the injection with PREVNAR 13. The redness spread down the arm so patient went to clinic. She was diagnosed with cellulitis. Patient was given BACTRIM and is getting better.
red knots that were swollen / right thigh had 2-3 streaks of red marks; arm "welted up" with big, red knots that were swollen; red knots that were swollen and painful (especially on the wrist, knuckles, and forearm) / soreness; Inflammation; Itchiness; welted up; red knots; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On 28th August 2020, less than a day after receiving Shingrix, the patient experienced erythema, swelling arm, pain, inflammation, pruritus, welts and mass. The patient was treated with benadryl (nos) (Benadryl). On 29th August 2020, the outcome of the erythema, swelling arm, pain, inflammation, pruritus, welts and mass were recovered/resolved.   It was unknown if the reporter considered the erythema, swelling arm, pain, inflammation, pruritus, welts and mass to be related to Shingrix.  Additional details were provided as follows: The patient did not have known allergies, and never having a bad reaction to anything before. It was reported that the patient experienced a bad reaction after getting the 1st dose of the Shingrix vaccine.  The patient received the 1st Shingrix shot, on her left arm as well as the pneumonia shot on her right arm. About 3-4 hours afterwards, her left arm welted up with big, red knots that were swollen and painful (especially on the wrist, knuckles, and forearm).  The patient's inner right thigh had 2-3 streaks of red marks that were not as bad as the reaction on her left arm. She also experienced soreness, inflammation, and itchiness. The patient took Benadryl the next day, and not too long after everything got better and the reactions were subsided.  The reporter consented to follow up.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 17-year-old female patient received TRUMENBA; (lot T52806, expiration date 31Dec2019), in right arm, at single dose and MENACTRA in left arm, both on 06Sep2018, for immunization, in the Doctor's office. Medical history and concomitant medications were not reported. On an unspecified date in Sep2018 swelling occurred in the right arm. The patient was admitted to the ER for high fever, vomiting and swelling. The events lasted 5 days and resolved on an unspecified date in Sep2018. Sender's Comments: Based on the information available, the Company cannot exclude that the suspect meningococcal group b rlp2086 contributed to the development of the reported events.
One day following administration of Menactra (MCV4) developed some swelling around site. The next day developed erythema 6"x5", induration 3"x4" and some itching-Ibuprofen-ice