chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported in a literature article and described the occurrence of sterile abscess in a 4-month-old subject of unspecified gender who was vaccinated with DTaP vaccine (manufacturer unspecified), PCV7 vaccine (non-gsk), Hib+HepB (non-gsk) and IPV (non-gsk). On an unspecified date, the subject received an unspecified dose of DTaP vaccine (administration site and route unknown, batch number not provided), an unspecified dose of PCV7 vaccine (NON-GSK) (unknown), an unspecified dose of Hib+HepB vaccine (Non-GSK) (unknown) and an unspecified dose of IPV (Non-GSK) (unknown). 21 days after vaccination with DTaP vaccine, Hib+HepB vaccine (Non-GSK), PCV7 vaccine (NON-GSK) and IPV (Non-GSK), the subject experienced sterile abscess. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was probably related to vaccination with DTaP vaccine, PCV7 vaccine (NON-GSK), Hib+HepB (Non-GSk) and IPV (Non-GSK). This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful.  The author's conclusion stated that the CCCR provides advice about AEFO to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Information has been received from a physician concerning a 16 week old female with a history of nasal congestion and constipation who on 22-JUL-2008 was vaccinated with PEDVAXHIB.  Concomitant therapy included PEDIARIX and PREVNAR.  On 11-SEP-2008 the baby was seen for an upper respiratory infection (URI).  Eating and drinking well  with good urine output.  Mother described clear nasal drainage without respiratory difficulty and no fever.  Symptoms were better with TYLENOL.  Fluids, vapor, nasal saline and over the counter acetaminophen was recommended and follow up in 3 days if not significantly better, or sooner if worse.  On 01-OCT-2008 the baby was seen for a 4-5 month well child visit with no concerns from parents and was doing well.  No further information is available.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a second expired dose of GARDASIL (Lot # 666929/0331Z, expiration date 20-NOV-2012) on 07-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 20 year old male patient with eating disorder, anorexia nervosa and none drug reactions or allergies. On 21-MAY-2012 the patient was vaccinated with the first dose of GARDASIL injection, intramuscularly in the deltoid (strength, lot number and expiration date not provided). No adverse event reported with the first dose of GARDASIL. On 27-JAN-2014 the patient was vaccinated with the second dose of GARDASIL 0.5 ml injection, intramuscularly in the deltoid (lot number # J009243, expiration date: 23-APR-2016). Concomitant therapies included PROZAC (dosage not provided). The nurse reported that on 27-JAN-2014 a patient developed syncope 20 minutes after the second dose of GARDASIL was given, he fell and hit his head and then had seizure like activity. The nurse reported that the patient was made to lie down with feet elevated and was recovered within 45 minutes of the syncope attack. The patient sought medical attention during office visit and had a blood pressure monitored. The outcome of events was reported as recovered/resolved on 27-JAN-2014. The relatedness between vaccination with GARDASIL and events was not reported. Additional information has been requested.
Red swelling in arm  (size of tea cup saucer); painful for 2 days now itchy Sore neck, back, joints event without movement.  100.5 fever, chills and headache. Nausea
Immediately after administering the vaccine child experienced vasovagal syncope. Time of unconsciousness less than 10 seconds. Child confused upon awakening. Vital signs taken immediately following event and periodically after. All VS stable. Child laid on exam table with feet elevated for nearly an hour. Discharged from clinic in wheelchair due to dizziness. Mom declined to take child to ER at that time and elected to take child home to be monitored by mom. Mom with child throughout entire event.
48 hours after vaccine-developed severe headache/muscle aches and fever and vomiting.
This case was treated by a other health professional and described the occurrence of incorrect storage of drug in a patient who received INFANRIX. Co-suspect products included PEDIARIX, KINRIX, HAVRIX, ENGERIX B, BOOSTRIX, FLUARIX and FLUARIX QUADRIVAENT. On an unknown date, the patient received INFANRIX at an unknown dose, PEDIARIX at an unknown dose, KINRIX at an unknown dose, HAVRIX at an unknown dose, ENGERIX B at an unknown dose, BOOSTRIX at an unknown dose, FLUARIX at an unknown dose and FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving INFANRIX, PEDIARIX, KINRIX, HAVRIX, ENGERIX B, BOOSTRIX, FLUARIX and FLUARIX QUADRIVALENT, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Vaccines stored at too cold of temperature were administered to multiple unknown patients. INF, PDX, KIN, HVR, ENG-B, BST, FLX, FLX QIV all exposed on multiple occasions since 10/1/14 to colder temperatures to 31 deg F. They were reading manual thermometers mornings and evenings. Now they have these 31 deg F recordings since they put in place continuous monitoring and VFC is requiring them to contact us. They have given over the past month these exposed vaccines to various children in this clinic. Nurses were under impression if temp got below 32, as long as it got back up it was ok. Long-standing practice according to this administrator. They will have to back track to see patients were given the vaccine now.
After her first dose she had a little swelling on her left arm where the injection was and a little bit swelling in the lymph nodes in her armpit.; After her first dose she had a little swelling on her left arm where the injection was and a little bit swelling in the lymph nodes in her armpit.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "After her first dose she had a little swelling on her left arm where the injection was and a little bit swelling in the lymph nodes in her armpit.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After her first dose she had a little swelling on her left arm where the injection was and a little bit swelling in the lymph nodes in her armpit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
soreness on the upper left area of her chest; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (soreness on the upper left area of her chest) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Smoker.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in her arm). On 24-Mar-2021, the patient experienced CHEST PAIN (soreness on the upper left area of her chest) (seriousness criterion medically significant). On 23-Mar-2021, VACCINATION SITE PAIN (soreness in her arm) had resolved. On 26-Mar-2021, CHEST PAIN (soreness on the upper left area of her chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  This case concerns a 55-year-old female with a serious unexpected event of chest pain, and nonserious expected vaccination site pain. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 55-year-old female with a serious unexpected event of chest pain, and nonserious expected vaccination site pain. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Itchy; Eye swelling; Hives; Tingling upper lip; tenderness near the injection site; injection site swelling; A spontaneous report was received from a consumer who was a 43-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling near injection site (vaccination site swelling), tenderness (vaccination site pain), itchy (eye pruritus), swelling of eyes, hives (urticaria) and tingling of upper lip (paraesthesia  oral).  The patient's medical history was not provided. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the same day, the patient experienced, swelling near injection site and tenderness.  On 02 Jan 2021, the patient developed, itchy, swelling of eyes, hives and tingling of upper lip. The patient checked herself into the emergency room (ER) at this point. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, swelling near injection site, tenderness, itchy, swelling of eyes, hives and tingling of upper lip was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8731), at the age of 50, via an unspecified route of administration, left arm, on Apr 9, 2021, at 14:00, single dose, for COVID-19 immunisation. Other medical history reported as none. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 10, 2021, at 12:00, patient experienced all the typical side effects of the vaccine, including fatigue, aches, headaches, fever and appetite loss. Instead of lasting 2-3 days, this lasted a whole week and hasn't gone away completely at the time of this report. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of aches, appetite loss, fatigue, headache and fever: not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
5 mo old with generalized exanthem about 21 days after vaccine receipt with affected site initially to his face, and progressed over several days to include torso, all extremities, scalp, neck and back. The flexor sites were more exacerbated. The dermatitis was characterized by pruritic fine papules, followed by macules, and scaling. No fever, malaise, and continued usual activity, eating and drinking. He had fever and emesis on day 44 and was treated for scarlet fever, strep was negative. Exanthem continued to evolve with peak at 46 days post vaccine receipt. . Derm consult differential eczema, Id reaction, viral exanthem and less likely psoriasis. Final Dx at follow up most likely viral exanthema vs. new onset eczema.
LEFT ARM PAIN BEGINNING 7 DAYS POST 4TH PFIZER VACCINE.  PATIENT DOES NOT HAVE INSURANCE AND HAS NOT SEEKED MEDICAL CARE AT THIS TIME. ADVISED PT TO VISIT URGENT CARE NEAR HOME IF ABLE.
Syncope, repeat episodes over an hour, observation o/n in hospital. 7/21/08-records received for DOS 7/8-7/9/08-DC DX-Syncope episode, status post Gardasil, resolved. After receipt of vaccine, presyncopal and then passed out time 3.
Had 4 vaccinations at the same time. Chicken pox, Hib, Hepatitis and MMR. 12 hours after recieving shots, he began running a fever of 104. The fever stayed between 102-104 for several days. He was always twitchy and very out of it. His legs are to this day extremely sore, he will not walk on them sometimes and will not stoop, etc. The area he recieved the shots is very hard.   Doctor assured it was not from shots and then marked off chicken pox on our checkout sheet. Then she called ot let me know he may get a fine rash since that is common with viruses (as a nurse and a 31 year old individual, i know that is not a common occurence). She was trying to make sure she put no blame on the vaccine while letting us konw it was the vaccine, i guess.
Fever, fatigue, chills, lethargic.  Ibuprofen  Seen in urgent care 9/28/2022
left side of face went numb; Tingling like it was asleep; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA and PARAESTHESIA in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Heartburn. Concomitant products included NEXIUM for Heartburn.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced HYPOAESTHESIA and PARAESTHESIA. At the time of the report, HYPOAESTHESIA was resolving and PARAESTHESIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. The patient experienced the left side of her face went numb and tingling like it was asleep. The patient said the numbing never really went away but decreased Patient reached out to her doctor about getting the second shot. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) (batch number was 21C21A). Patient got the second dose of the Moderna vaccine did not have any additional side effects. Patient reported being on Nexium for heartburn before receiving the Moderna vaccine. This case concerns a 40-year-old female patient with no relevant medical history, who experienced the unexpected event of Hypoesthesia and Paraesthesia. The events occurred the same day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Redness, swelling, itching at injection site- treated with OTC antihistamine/cool compress
256 mom bring pt to clinic w/ c/o orange rash over pts body & the pt vomited a brown liquid;
21 year old male with reaction to smallpox vaccine. Erythema 1mm spots to arm, back, shoulder. No streaking, No pustules noted. Possible generalized vaccinia.
pt recv vax & devel fever  inj site rxn characterized by redness & swelling;
Extreme pain in arm at injection site beginning 6 hours after injection and lasting 4 days. Fever, chills, shaking, body aches beginning 6 hours after injection and lasting 2 days.
Mom called and stated pt broke out on stomach 1-21-06 with bumps w/o heads. Has gotten worse with bumps on neck chin and arms. No temp.
He started complaining with a headache on Sunday afternoon. He had a slight fever Sunday night. Monday morning, he had a fever and started throwing up. The fever increased. I took him to see his pediatrician on Tuesday, he still had the same symptoms. His fever was 104.5 when I took him to the doctor. The doctor did a flu, covid, strep tests. All negative. They gave him ibuprofen while we were there. Also, some medication for nauseas. They also did bloodwork, and they said his inflammatory markers and white blood cells were elevated. We went back to see the pediatrician the next day because he was not feeling well. He repeated the bloodwork, and it was still the same. He recommended to go to the local hospital because he needed fluids for dehydration. We went to the hospital, and they ended up admitting him and he stayed there until 10/24/2021. When he was first admitted they thought he had MSC, but they did a COVID-19 antibody test, and it was negative. They ended up treating him for tick illness. They gave him doxycycline for that. We do not know if that is what he had for sure. He also received the flu shot on 09/21/2021.
Horrible neck pain; Lower back pain; Can't even stand; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Horrible neck pain), BACK PAIN (Lower back pain), DYSSTASIA (Can't even stand), PYREXIA (Fever) and CHILLS (Chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035N21A and 035N21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Horrible neck pain), BACK PAIN (Lower back pain), DYSSTASIA (Can't even stand), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, NECK PAIN (Horrible neck pain), BACK PAIN (Lower back pain), DYSSTASIA (Can't even stand), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 20-DEC-2018 the patient was vaccinated with an expired dose of ROTATEQ (lot # N010709, expiration date: 05-DEC-2018, strength and frequency were unknown) orally for prophylaxis (expired vaccine used). No adverse effects were reported.
Pt developed vesicular rash on the same arm that he received the flu vaccine, 2 days after receiving vaccine. Pt did not report rash until 11/15 and presented to office on 11/20. Pt diagnosied with Shingles and started on valcyclovir 1g tid.  Pt with vesicular rash over entire Right arm and scapula region
Worsening itchy rash on the belly (20cm x 13cm). loratadine 10mg Bid, triamcinolone 0.1% cream applied QID. Limited efficacy. Affecting sleep and daily activities.
Swollen raised area around and below the injection site which is hot to the touch. Area is approximately 2-3 inches by 4-5 inches. Arm is sore, especially when moved. Area is still like this after a week.
Given 0.25 instead of 0.5 ml.  No complications. Needs correct dose.
Itchy injection site; Red injection site; A little swollen injection site; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE SWELLING (A little swollen injection site) and VACCINATION SITE PAIN (Sore injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE SWELLING (A little swollen injection site) and VACCINATION SITE PAIN (Sore injection site). On 26-Feb-2021, VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (A little swollen injection site) and VACCINATION SITE PAIN (Sore injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.