chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Adult patient received a pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant concerning to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 22-DEC-2021, the adult patient was vaccinated with a pediatric dose (incorrect dose administered) of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB), 5 mcg/0.5 mL strength, lot number U001837 with expiration date reported as 21-NOV-2022 but internally validated as 28-APR-2023 for prophylaxis (dose, route of administration and anatomical location were not reported).  No adverse event or product quality complaint (PQC) were reported.  At the reporting time, the patient's outcome was unknown.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA004547: US-009507513-2203USA004223:
sore arm; Covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid 19) and PAIN IN EXTREMITY (sore arm) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (First dose) on 27-Jan-2021, Pfizer vaccine (Second dose) on 17-Feb-2021 and Pfizer vaccine (Third dose) on 20-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 06-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Covid 19). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, COVID-19 (Covid 19) had not resolved and PAIN IN EXTREMITY (sore arm) had resolved.            The last shot patient got in Oct they got with the flu shot in the same arm. Second covid diagnosis was on 22-APR-2023 No treatment information was reported.   This case was linked to MOD-2023-741231 (Patient Link).
Patient came into pharmacy 8 days after vaccine administration (vaccine administered 9/17/150 and told me at 8pm (same day of administration) he had fever chills and shaking. His wife took him to ER and they gave him IV fluids and that he had a fever and left ER and went home after being there for 5 hours.
runny nose, diarrhea, headache, heartburn, stomachache, one day of feeling ill, went home and slept.
Chills, migraines, vomitting, excessive sweating, dizziness, fogginess, fever, weakness, very tired
severe body ache  weakness the arm where vaccine is given was painful, itchy and is still swollen as big as my palm
11/21/99 4:20am child crying, mom entered bedroom and child was seizuring. EMS took to ER w/temp 105. ER Dr could not find any reason for seizure other than fever. Child disch at 7:30am. No further seizures.
The night of vaccination I had some pain. The following day I woke up during the night with the chills and fever. I had pain all over my body. My doctor advised Tylenol. I still had terrible headaches and body aches. The symptoms went on for three days and then they started to ease. Overall, l I had the lump on my arm and some shortness of breath or two weeks. I feel some forgetfulness and I am easily tired still. After the first shot I had much milder than after the second dose.
Pain at injection site for about 3 days- Tylenol Headache for 2 days  - Tylenol Fatigue for 2 days - rest
Hives all over body they were larger and worse on the side of my body where I received vaccine. Received vaccine at 10:20 and hives started at 11:00 . Immediately took 2 Benadryl tablets with some relief repeated every 6 hours. Today 4/27/21 I stopped taking the Benadryl and around 6pm I broke out in hives and extreme itching again.
Felt unable to answer questions possibly hypoglycemic event, felt something in back of throat, symptoms resolved after providing apple juice
little swelling on her forearm; arm was swollen from shoulder to elbow; completely red; Rash goes from vaccine site to 2 inches above elbow; rash at injection site going down to her elbow; left arm felt sore; felt like she was hit by a truck; loss of appetite; whole upper body was sore; fever; shivering; joint pain; fatigue; arm was a little sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (loss of appetite), AXILLARY PAIN (arm was a little sore), FEELING ABNORMAL (felt like she was hit by a truck), AXILLARY PAIN (left arm felt sore) and SWELLING (little swelling on her forearm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer since an unknown date and Breast conserving surgery. Concurrent medical conditions included Hypertension, Drug allergy (Allergic to penicillin.) and Drug allergy (Allergic to sulfa drugs.). Concomitant products included LOSARTAN for Hypertension, TAMOXIFEN and ACETAMINOPHEN for an unknown indication.  On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced AXILLARY PAIN (arm was a little sore).   On 18-Feb-2021, the patient experienced DECREASED APPETITE (loss of appetite), FEELING ABNORMAL (felt like she was hit by a truck), PAIN (whole upper body was sore), PYREXIA (fever), CHILLS (shivering), ARTHRALGIA (joint pain) and FATIGUE (fatigue).   On 19-Feb-2021, the patient experienced AXILLARY PAIN (left arm felt sore) and INJECTION SITE RASH (rash at injection site going down to her elbow).   On 22-Feb-2021, the patient experienced SWELLING (little swelling on her forearm), PERIPHERAL SWELLING (arm was swollen from shoulder to elbow), VACCINATION SITE ERYTHEMA (completely red) and VACCINATION SITE RASH (Rash goes from vaccine site to 2 inches above elbow).   At the time of the report, DECREASED APPETITE (loss of appetite), AXILLARY PAIN (arm was a little sore), FEELING ABNORMAL (felt like she was hit by a truck), AXILLARY PAIN (left arm felt sore), SWELLING (little swelling on her forearm), PERIPHERAL SWELLING (arm was swollen from shoulder to elbow), PAIN (whole upper body was sore), PYREXIA (fever), CHILLS (shivering), ARTHRALGIA (joint pain), INJECTION SITE RASH (rash at injection site going down to her elbow), VACCINATION SITE ERYTHEMA (completely red), VACCINATION SITE RASH (Rash goes from vaccine site to 2 inches above elbow) and FATIGUE (fatigue) outcome was unknown.      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.   No treatment information was provided.
Day 1 headache and nasuea that subsided by 7 PM. 1 week later started having sensitivity and pain in scalp with headaches. On 3/27 I had a bump on back of neck.  3/28 rash appeared on left side of neck and on face along jawline.  I also had painful sores appear in my scalp on left side.
Patient returned to vaccine clinic approximately 2 hrs after receiving Pfizer vaccine.  She waited in vaccine clinic waiting area 15 minutes, then sat in hospital waiting area an additional hour (her own decision) then started feeling numb around her lips and part of her tongue, as well as heartburn symptoms.  By the time she reported back to vaccine clinic, she said she was mostly better, but still had some circumoral numbness and the tip of her tongue was numb.  Patient evaluated by RN and MD working in vaccine clinic; no swelling noted. Lips and tongue normal in appearance.  Pt. denied any shortness of breath.  VSS (139/63, HR 100, 95% O2sat).  Pt declined to go to ED and discharged home without any other known complications.  Patient received second Pfizer vaccine on 3/2 (lot# EN6198) without known complications.
1 week after receiving the Moderna injection I started with pain under my left arm and left breast. The pain in my breast is a severe sharp stinging pain that goes through out my breast. The pain has not resolved as of today and I was told to report the adverse reaction per employee health. I had a normal mammogram 2 weeks prior to having the injection.
Case number PHEH2014US020660 is an initial spontaneous report received from a pharmacist on 10 OCT 2013. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX 2014/2015 (batch number: not reported) on 10 OCT 2014. On the same day after vaccination, patient experienced some kind of skin reaction . It was further reported that the FLUCELVAX was kept out from refrigerator (not for long time) and might have reached room temperature before administration. Final outcome, causality and seriousness were not reported.
This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician. The medical assistant reported similar events for 2 patients. This is the 2nd of 2 cases. A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration, on 08May2017, at 0.5 ml single, for immunisation.  Medical history included ongoing hyperlipidaemia, ongoing depression, ongoing vitamin d deficiency, ongoing osteoporosis, ongoing glucose tolerance impaired. Concomitant medication included ongoing VOLTAREN, ongoing calcium (unspecified trade name), ongoing hydrochlorothiazide (HCTZ), ongoing losartan (unspecified trade name), ongoing LIPITOR, ongoing PAXIL, ongoing fexofenadine (unspecified trade name). The patient experienced burning when the medication went in on 08May2017 with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017207726 Same reporter/drug/event, different patient.
Tues 2/23/2021: fever no greater than 101, chills, fatigue, body ache, headache all day, very sore arm. Fever treated with tylenol Wed 2/24/2021: No fever in morning, but headache, body ache, mild fatigue all day, sore arm, then fever of 102 in evening (about 5 pm). Treated with Tylenol successfully, fever abated pretty quickly. Thursday 2/25/2021: No fever or headache, but arm still pretty sore without tylenol. Friday 2/26/2021: feeling fine, arm is very slightly sore.
13X10cm swollen area. Mildly warm to the touch. No axillary or supra trochlea adenopathy, no elevated temperature. No other skin lesions. No swollen joints
Chills, fatigue, body aches, headache, fever, nausea  Took Tylenol after 24 hours Helped lessen the symptoms. Took more Tylenol after 6 more hours.  48 hours later-am 70% improved.
Red rash at injection site.  Slightly warm to the touch, red and slightly itchy.  Known as "Covid Arm"
hives on arms, neck on day 1. burning sensation. still hives on 3/4/21 but resolving with Benadryl, limited to arms. itchy but less severe.
Vaccine given on 9/23/21 with expiration date of 9/21/21. Janssen notified/consulted; inquiry #0259438. Dr.  notified/consulted. Patient notified. Suggested antibody testing be done 2 weeks after receiving vaccine.
came down with Covid after being vaccinated; came down with Covid after being vaccinated; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A male patient in his 50's(this 50 something man) received bnt162b2 (Pfizer Covid-19 vaccine), administration date May2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "came down with Covid after being vaccinated".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101750040 Same reporter/drug/event, different patient
I became Tachecardia two hours after injection. This lasted for 72 hours. I was weak, dizzy, lightheaded, and pale. I went to the emergency room three days after my vaccine. I was then diagnosed with Auto-Immune Hemolytic Anemia with a hemoglobin of 5.1, requiring an ICU stay for two days with three blood transfusions. I was in the hospital until 4/7/21.  I returned to the hospital days later on 4/11/21 with ovarian torsion. This was very painful and required five more days in the hospital and two more surgeries, one to turn the ovary on 4/12/21 and one to remove my ovaries on 4/21/21.
8/3/22 The patient started with slight cough.  8/4 received 1st Pfizer COVID dose.  seemed ok 8/5, 8/6.  Evening of 8/7 was cranky & ate less than usual.  8/8 - sent to daycare, got a call from daycare approx 11am that he had a fever, sent home from daycare.  There were other kids at daycare with fever & diarrhea.  Gave tylenol x 1 with resolution of fever.  Fever did not recur.  Had 2-3 episodes of diarrhea between 8/8-8/9.  Decreased appetite.  Went back to school on 8/10.  Still not eating well.  On 8/12 very poor appetite,  seemed lethargic.  Not wanting to play, asking to be carried around (instead of running around as he usually dose).  Overnight 8/12-8/13 did not sleep well, vomited x 1. morning of 8/13 poor appetite, vomited x 1 & had diarrhea (which had not occurred since 8/9).  Taken to Doctor on 8/13 - MD not overly concerned, advised to monitor closely over next few days.   Suspect above symptoms were related to a mild URI he had PRIOR to vaccination and diarrheal illness he acquired at daycare, not vaccination.
QUADRACEL was given to a 7-year-old patient with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 7 years old male patient who was given diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Jun-2023, 7-year-old patient received a total dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection (lot number, dosage, strength, expiry date-  not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency- same day). Information on the batch number was not available.  Reportedly, A medical assistant asks for safety information regarding administration of QUADRACEL to inappropriate age group and reports that they have a 7-year-old patient who was given QUADRACEL on 27Jun2023; caller states the patient has not been seen in the office since 05Aug2020, the vaccination records don't get reviewed by a nurse due to the patient is a home school child, inadvertently, quadracel was given to the patient even though he is 7 years old.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.  No follow-up is possible as Reporter cannot be contacted by Sanofi.
Patient received his 1st dose of Janssen COVID-19 in his left arm and about 1 minute after receiving the patient slumped in the chair. When the patient was able to speak to the pharmacist  he stated that he felt like he could not breathe. The patient was given 1 dose of epipen 0.3 mg and emergency services was called. A police officer and the EMT's arrived on the scene and took over the patient's care.
Large area of erythema and slight swelling on right thigh. Slightly pruritic, not tender or painful, slightly warm to the touch. Sore and Fussy day after vaccines but normal active self since.  Treatment, cold compress, ibuprofen for pain and Benadryl if needed for itching.
Systemic: see description below-Mild, Additional Details: Patient came to get flu shot and rph prepared flu shot for administration. after gathering supplies, a pfizer vaccine dose was picked up accidentally and pharmacist poked the needle into arm of patient, and pulled syringe right back out. no pfizer vaccine was administered. Told pt what happened and pt wanted to go ahead get pfizer booster dose because of her age and other criteria. rph typed up vaccine, pt filled out consent form. pfizer dose was then actually administered.
Glands under arm are swollen; Glands under arm are tender; "chills, but they seem to be in just lower extremities, below my waist."; Jaw went numb; Stiff neck just on one side and not for a long period of time; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Jaw went numb), MUSCULOSKELETAL STIFFNESS (Stiff neck just on one side and not for a long period of time), LYMPHADENOPATHY (Glands under arm are swollen), TENDERNESS (Glands under arm are tender) and CHILLS ("chills, but they seem to be in just lower extremities, below my waist.") in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration. Concomitant products included BILBERRY [VACCINIUM MYRTILLUS], GINKGO BILOBA and CALCIUM for an unknown indication.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced HYPOAESTHESIA (Jaw went numb), MUSCULOSKELETAL STIFFNESS (Stiff neck just on one side and not for a long period of time) and CHILLS ("chills, but they seem to be in just lower extremities, below my waist."). On 12-May-2021, the patient experienced LYMPHADENOPATHY (Glands under arm are swollen) and TENDERNESS (Glands under arm are tender). On 07-May-2021, HYPOAESTHESIA (Jaw went numb), MUSCULOSKELETAL STIFFNESS (Stiff neck just on one side and not for a long period of time) and CHILLS ("chills, but they seem to be in just lower extremities, below my waist.") had resolved. At the time of the report, LYMPHADENOPATHY (Glands under arm are swollen) and TENDERNESS (Glands under arm are tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported also included Complete Eye Health and OPC Synergy. No treatment information was reported.
Information has been received from a pharmacy technician concerning a female pt who on approx 10/5/05 was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650083/0746P). Subsequently, in Oct 2005, the pt experienced a local site reaction post vaccination. the pt called the office to report a red, raised, warm, and achy area at injection site. He was treated with cold compresses and acetaminophen Tylenol as needed. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
23NOV97 to IC w/t104 then 2hr later to ER w/104;had sz going from ICC to ER;recv Rocephin & APAP;25NOV97 to family MD where MD said rxn d/t DTP;
Pruritus immediately after shot. Developed redness within the next 24 hrs and extends out 10cm diameter. Persists one week after shot. This is all at location of injection site (R) deltoid.
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
flare-ups where my eyes get completely puffy; underneath my eyes there's splotches of red patches; flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I'm allergic to Penicillin" (unspecified if ongoing), notes: She added "I'm allergic to Penicillin, So I'm not sure if the vaccines have penicillin in them?. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Underneath my eyes there's splotches of red patches", "Flare-ups where my eyes get completely puffy", "Flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "Underneath my eyes there's splotches of red patches", "Flare-ups where my eyes get completely puffy". The following information was reported: PERIORBITAL SWELLING (non-serious), outcome "unknown", described as "flare-ups where my eyes get completely puffy"; OCULAR HYPERAEMIA (non-serious), outcome "unknown", described as "underneath my eyes there's splotches of red patches"; SWELLING FACE (non-serious), outcome "unknown", described as "flare up where my entire face just completely swelled up specifically my eyes and underneath my cheeks". Relevant laboratory tests and procedures are available in the appropriate section  Additional information: The patient had received 3 Pfizer shots the last one was in December, from past month and half the patient was suffering from weird allergic reactions around her face.  Reported NTID number.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 1JUL95 & over the next 24 hr became febrile (T max 38 degree C ax), tachycardic (HRmax 200bpm); exhibited periods of irritability progressing to lethargy; became poor feeder;