chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain started upper extremities and has gradually worsened over the months so painful I can't use them.
Patient felt very weak and faint after receiving.  She did not appear to lose consciousness as she could tell me her symptoms, but was lying in chair for a couple minutes.  Had her lay on floor with feet elevated for a few minutes, then she said she felt better and wanted to sit.  Had her sit on floor until no longer feeling dizzy and could move to chair.  She contacted a family member to come get her and was feeling much better after 30 minutes.
FATHER LISTED YEAR OF BIRTH AS 2009 ON SIGNED QUESTIONNAIRE AND CONSENT FORM.  VACCINE WAS UNKNOWINGLY ADMINISTERED TO 11 YEAR, 7 MONTH OLD PATIENT.  NO ADVERSE EVENTS REPORTED BY PARENTS/GUARDIANS THUS FAR.
I had a severe sore throat, and I had a severe achy body with coughs and various fevers for 2 weeks. I missed 2 weeks of work for that. I lost my voice for a week after that. I still have an achy body just not as severe, and I have brain fog. I had a telehealth visit with a doctor. I was prescribed steroids, antibiotics, and an inhaler.
Symptoms- light headedness, dizziness while in the 30 minute observation window, EE reports she drank water and immediately felt better. EE also endorses mild HA shortly after. EE endorses symptoms completely resolved by 1:30 pm. Called vaccine support line at approximately 3:43 pm to notify us for our records.
Subsequent to receiving varicella virus vaccine live pt experienced chickenpox characterized by itching. It was indicated that the pt ha approximately 100 lesions covering his back, chest, arm and scalp areas. The pt was afebrile.
Pt recvd 1 dose of Engerix-B & devel swollen lymph nodes in groin which are still present;
Got menstral cycle twice within 1 month, the second menstral was heavier flow.
Started within 2 days of injection where site of injection was red, swollen, and then became itchy. Within 2 days spread to elbow area and to wrist. All on Left side. Within a few days the rash spread to the L nipple and the R forearm. Now nearly 2 weeks later I have minimal rash on my L torso, L lower thigh, and more moderate rash on several fingers of both hands. The areas basically look like dermatitis. The itch is mild to moderate. I see reduction of rash on the upper arm that was injected but in other areas it persists. Treatment has been Loratadine 10mg 1/day.
Body pain; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain), CHILLS (Chills) and HEADACHE (Headache) in a female 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 PAIN (Body pain), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Body pain), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: TCR declining further FUP
Arm at sight and shoulder sore, pain in left side of upper back.  Not feeling well.  Slight temp., cold, nausea, threw up, diarrhea, right eye watery, slight runny nose.  7:30 PM B/P 187/91.  Went to ER. Testing neg.  Took 5 days before feeling somewhat better.  15 days later still not feeling like I did before vaccine.  B/P still not at previous numbers. Eye remains water and nose runny.
Pt developed red raised area around injection site mom reports was as round as baseball yesterday but today the redness & swelling has decreased. I measured the red raised area today and was 9 cm X 4 cm. Treatment includes advising mom to put ice and MOTRIN.
Patient felt lightheaded and tired.  Felt like he couldn't perform his job.  He was sent home from work.
Extreme pain in arm, sever headache, dizzy, nausea, high fever of 102, confusion, entire body pain,  severe neck pain and stiffness, seizure like body tremors,  fatigue
Patient called the pharmacy complaining of pain radiating underneath his arm into his shoulder. He currently is taking Tylenol to relieve the pain.
Fever; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: OCREVUS. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 12 month old white female with no known allergies or pertinent medical history who on 10-SEP-2007 was vaccinated IM (previously reported as SC) with a 0.5 ml dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) and a dose of Varivax (Oka/Merck) (MSD).  The vaccines were given in separate syringes.  No adverse event was reported.  No further information was provided.  There was no product quality complaint involved.  Follow up information received from the medical assistant indicated that on 12-SEP-2007 the patient developed fussiness (it was noted the patient was also teething).  On 10-SEP-2007 the patient recovered.  Additional information is not expected.
Information has been received from pharmacist (Pharm. D.) concerning a 24 year old male who on unknown dates was vaccinated with 2 doses of VARIVAX (Merck) (lot # not reported). The reporter stated that patient developed chickenpox. After having chickenpox, patient was given 2 doses of VARIVAX (Merck). A recent varicella titer was "low". At the time of reporting, the outcome of the patient was not recovered. Varicella titer was performed. It was unknown if the patient sought medical attention. Additional information has been requested.
pt devel lesions consistent w/varicella in crops-initial lesions were scabbed-no fever;
No adverse event; TE evaluation states vaccines had been administered to multiple patients; This spontaneous report was received from a medical assistance and refers to a 14-month-old male patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 29-MAR-2022, the patient was vaccinated with the first dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported) administered subcutaneous route, lot # U025790 and expiration date 19-AUG-2023 administered as prophylaxis.   The improperly stored dose of the suspect vaccine experienced a temperature excursion of -14 degree celscius (C) up to -10 C for 3 hours and -10 C up to 8 C for 1 hour and 30 minutes on 23-MAR-2022; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments:  US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA007852: US-009507513-2205USA007821:
chills; get occasionally warmer but temperature is normal/feeling warm in her body or feverish but never had a temperature/ 99 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via unspecified route in the left arm single dose for COVID-19 immunization on 28Dec2020, 16:45 at 39-year-old. No medical history. Concomitant medication was not reported. No additional vaccines administered on same date of the vaccination or within 4 weeks before the vaccination. The patient had a little bit of chills on 31Dec2020. The chills was on and off, it may have even been on 01Jan2021. The patient occasionally felt warmer, but her temperature was normal. She felt warm inside her body or feverish on 29Dec2020 but never had a temperature. She still felt the chills and feverish on and off. She had it all day yesterday 05Jan2021. The temperature was 99 degrees Fahrenheit on 05Jan2021, but she had been working in the house. After she sat down for a while the fever went away. The chills and feeling like she might have fever are persisting through today. She didn't treat the chills or feverish in any way. No physician office or emergency room visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
Information has been received from a physician concerning a 26 year old female who on 01-OCT-2007 was vaccinated with her first dose of Gardasil (lot# 0530U).  Concomitant therapy included hormonal contraceptives (unspecified).  On 01-OCT-2007 the patient experienced pain, bruising and a lump at the injection site.  Subsequently, the patient recovered from pain, bruising and a lump at the injection site.  On 10-DEC-2007 the patient was vaccinated with her second dose of Gardasil (lot# 655154/1210U).  On approximately 31-DEC-2007 the patient developed a [[name]] ring, with a small [[name]] center at the injection site.  The patient's [[name]] ring, with a small [[name]] center at the injection site persisted.  Additional information has been requested.
1/22/08 around 2300pm c/o feeling nauseated, and then started vomiting, felt weak. Then had diarrhea. Felt like she had the flu. Had swelling, pain, redness. 1/23/08 had large amount of swelling, pain, redness. Today temp 99.3, Injection site red. States called 2 phy. states may be vaccine or stomach virus.
Right knee pain; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Right knee pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (He had a right knee replacement 8 years ago) in 2013.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced ARTHRALGIA (Right knee pain). At the time of the report, ARTHRALGIA (Right knee pain) outcome was unknown.            No concomitant medications were reported Treatment information was not provided
An expired dose of flu vaccine was inadvertently injected to a patient/no adverse event; Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case was linked with 2020SA283093 and 2020SA283083 (Same reporter).  This case involves a 53 year-old female patient who was inadvertently vaccinated with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] which had already expired (expired product administered).  Medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was reported.   On 07-Oct-2020, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ247AA and expiry date 30-Jun-2020) via intramuscular route at the left deltoid for prophylactic vaccination.  Case Detail: It was reported that 3 boxes of Fluzone Quadrivalent NP (no preservative) which was from last year. Each box had 10 syringes. One box was open. There were 3 Flu vaccines from last year that were inadvertently injected to 3 different patients. One of the patient was a doctor.  It was a case of actual medication error due to expired vaccine used (Latency was on same day).  At the time of report, no adverse event reported.  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.
PATIENT STATES RED ITCHY RASH AT INJECTION SITE APPEARED ON 02/03/2021. 7 DAYS AFTER RECEIVING THE MODERNA VACCINE.  THE RASH SIZE WAS EQUIVALENT TO A SILVER DOLLAR. PATIENT APPLIED CORTISONE CREAM AND SYMPTOMS RESOLVED.
having sensation in right hip that is hot; burning sensation in my hip joints; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (having sensation in right hip that is hot) and ARTHRALGIA (burning sensation in my hip joints) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PANTOPRAZOLE, VITAMINS NOS, GABAPENTIN and GALCANEZUMAB (EMGALITY [GALCANEZUMAB]) for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced FEELING HOT (having sensation in right hip that is hot) and ARTHRALGIA (burning sensation in my hip joints). On 19-Jan-2021, FEELING HOT (having sensation in right hip that is hot) and ARTHRALGIA (burning sensation in my hip joints) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Father stated patient woke up from nap and had white bumps with redness around all over body. Its starting to fade away. No lip swelling or tongue swelling. No difficulty breathing. Advised to use Benadryl 3.75 ml every 6 hours as needed. Advised to take to ER if she has any difficulty breathing or wheezing.
Pt recvd vax & devel hive type rash began about 2PM on the day of the inject; pt took DPH the rash got better;
Patient stated she could not breath and was not feeling well at all told pt to go to nearest ER.
Completed covid vaccine series on 2/21/21, started having symptoms on 3/29/21 and tested positive for covid on 4/1/21. Had known positive household exposure (mother in law and spouse).
Heart attack; Had three strokes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had three strokes". Clinical Course:Patient already took second shot on 08Apr2021 and he mentioned about the heart problem something (Transferring agent was unsure, hence not captured as event). So, we are not sure if that happened before he took the vaccine or after taking the vaccine. He mentioned, he had a heart attack. He would also like information on how to get the booster shot because they are unable to get it from their doctor (Further clarification was unknown).Patient have had a heart attack and I have had three strokes and I cannot find any place to get shots and neither can my daughter and my daughter calls up on these different places because she 'has a hole in her heart' (Not appropriately clarified over the call, hence split case was not made. LOT# I find on here is and that was 1170828. I can't read this stuff on here it's so small I can't read it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient received three vaccines, after receiving vaccines patient sat in office for another 15 minutes. Patient was then taken to checkout then left the clinic. Patient was leaving the building when patients father stated that he had to catch patient because he passed out. Patient did not hit head father grabbed him and put him in chair. Paramedic's where called by downstairs guard. Clinic nurses went downstairs to check on patient. Patient was alert and feeling better, patient stated that he did not feel dizzy anymore and was feeling much better. Paramedic came and assested patient, patient's blood pressure and blood sugar was checked and within normal limits. Patient did not go to hospital. Patient was assisted to the car and left with no complications.
multiple doses of improperly stored Gardasil 9, MMR II and Rotateq were administered; no adverse effects reported in any patients; This spontaneous report was received from an office manager, referring to multiple unspecified patients (age and gender not provided). The patients' medical history and concurrent conditions were not disclosed. Concomitant therapies included sterile diluent (STERILE DILUENT).     On an unknown date, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R027577 and expiration date 23-JUN-2021, lot # R028978 and expiration date 23-JUN-2021), for prophylaxis (strength, dose, frequency, anatomical injection site, route of administration were not disclosed).  Other suspect therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # R027997 and expiration date 01-OCT-2020, lot # R024910 and expiration date 30-AUG-2020, lot # R025335 and expiration date 06-APR-2020; for all lot # therapy type was rha), for prophylaxis (strength, dose, frequency, anatomical injection site, route of administration were not disclosed); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R027272 and expiration date 07-JUN-2020, administered orally for prophylaxis (strength, dose and frequency were not disclosed).   The office manager also reported that on unspecified dates, since 22-MAR-2019, 4 more doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028978 and expiration date 23-JUN-2021), that were improperly stored, were administered; as well as 3 more doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R027272 and expiration date 07-JUN-2020).  The specific lot number administered to each patient was unknown by the reporter.  Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (also reported as 57.06 degrees Fahrenheit) for 1 hour and 19 minutes; and it was also noted that they underwent a previous temperature excursion of above degrees Fahrenheit (also reported as 57.87 degrees Fahrenheit) for 3 hours. The office manager reported that the cumulative time frame of the temperature excursion was 5 hours 33 minutes.  It was reported that sterile diluent used to reconstitute measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) did not undergo a temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was involved.  Follow up information has been received on 09-OCT-2019, informing that all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Patient received her second dose "two weeks too early"; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second dose "two weeks too early") in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 038B1A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second dose "two weeks too early"). On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received her second dose "two weeks too early") outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
initially it was itchy, when the red circular spot appeared it was itchy one week after; circular to oval shaped red hard area at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (initially it was itchy, when the red circular spot appeared it was itchy one week after) and VACCINATION SITE ERYTHEMA (circular to oval shaped red hard area at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (initially it was itchy, when the red circular spot appeared it was itchy one week after) and VACCINATION SITE ERYTHEMA (circular to oval shaped red hard area at the injection site). At the time of the report, VACCINATION SITE PRURITUS (initially it was itchy, when the red circular spot appeared it was itchy one week after) and VACCINATION SITE ERYTHEMA (circular to oval shaped red hard area at the injection site) outcome was unknown. Not Provided      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 concomitant medication and treatment provided red area about 2-3 inches wide.
This is a spontaneous report from a contactable Nurse. This Nurse reported similar event for 2 patient. This is 1st of two reports. A 17-year-old female patient received TRUMENBA (NDC number: 0005-0100-10, Lot Number: S58896, Expiry date: 31Aug2019) at single dose on 07Jun2018 at 0.5ml single dose, via intramuscular route of administration into right arm for immunization. The patient had not medical history. The patient received first dose of the same vaccine at 16-year-old on 17Apr2017, via intramuscular route of administration into left arm from Lot number: R45100, Expiration date: 31Jul2018. On unknown date the patient also received GARDASIL (lot N026812, exp.date 22Jun2020) via intramuscular route. On 07Jun2018 the patient experienced severe arm pain in the injected arm and on unknown date she could not lift her arm. The outcome of the event severe arm pain was recovering because the patient had been taking Motrin for it, while the outcome of the other adverse event was unknown. The event severe arm pain was considered to be a serious important medical event.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect drug meningococcal group b rlp2086 contributed to the development of the reported event arm pain and could not lift her arm. ,Linked Report(s) : US-PFIZER INC-2018242439 same reporter/drug, similar event, different patient.
Eight hours after I had a headache extreme tiredness and chills for about 12 hours. A headache for four hours which was relieved by Tylenol. About 3 days after vaccine I noticed swollen lymph nodes. I was advised to call my doctor and the lymph nodes remained swollen for a month. Advised by physician that multiple lymph nodes swollen. They still feel like they are a little swollen.