chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 36 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. Concomitant therapies included unspecified flu vaccine. On 18-SEP-2017, the patient was vaccinated subcutaneously with PNEUMOVAX 23 lot # N010105, expiration date 15-NOV-2018. The patient developed pain, redness, swelling and the injection site was hot to touch later in evening of 18-SEP-2017 after administration of the vaccine. The patient went to the doctor's, and was diagnosed with cellulitis and treated with unspecified antibiotics. The outcome of cellulitis was reported as recovered on an unspecified date in 2017. The causality assessment was not provided. Upon internal review, the event of cellulitis was considered to be medically significant.
Pt recvd vax 15MAY92 & exp dizziness, chest tightness, lightheadedness, eyes were blurry, SOB, dry mouth, felt cold & clammy; looked pale & exp hypotension & an irregular heart beat; tongue felt thick & dry, throat felt dry, unable to swall
chest burning sensation; arm and shoulder  pain; arm sore left arm (injection site); headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest burning sensation), PAIN IN EXTREMITY (arm and shoulder  pain), VACCINATION SITE PAIN (arm sore left arm (injection site)) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced CHEST PAIN (chest burning sensation), PAIN IN EXTREMITY (arm and shoulder  pain), VACCINATION SITE PAIN (arm sore left arm (injection site)) and HEADACHE (headache). At the time of the report, CHEST PAIN (chest burning sensation), PAIN IN EXTREMITY (arm and shoulder  pain), VACCINATION SITE PAIN (arm sore left arm (injection site)) and HEADACHE (headache) had resolved.            No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated events outcome as recovered/resolved.
This spontaneous report as received from a physician refers to 5 patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On unknown dates the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L039092, expiration date 06-OCT-2017, dose and route not reported). It was reported that the vaccine was exposed to the following conditions: 3.5 centigrade for 3 hours and 14 minutes. No adverse symptoms reported. Additional information has been requested.
11/21-8:18 pm hives around right ear and both groin; 10:30 pm: right pinky toe numbness- almost like when your toes are really cold; 11:45 pm tachycardia- 11/22- 8:23 am insomnia, felt febrile, sneezing, puffy eyes, toe numbness still present; 9:30 am whole toe likes a red/blue, weird sensation in entire leg- have feeling in it, but feeling seems deeper not superficial.
Information has been received from a registered nurse concerning a 7 year old male who at 12 months of age (in approximately 2001) was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed 250-500 lesions across the trunk and a low grade fever. Lesions were scaly and looked very similar to shingles lesions. Therapy with varicella virus vaccine live was discontinued and the patient was reported to be recovering. The patient sought unspecified medical attention. In follow-up information it was reported that, "We have not had a 7 year old male with adverse experience to varicella vaccine, no one this age was diagnosed with varicella either." No further information is available.
preparing to give the PPD vaccine but instead gaveTyphim Vi/ no reactions noted; Initial information received on 18-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves adult patient of unknown demographics who was administered with 0.1 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (batch number: P1D631M and expiry date: 07-Sep-2020) via intradermal route on an unknown date instead of TUBERCULIN TEST [TUBERCULIN PPD].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  There were no concomitant vaccines given   It was a case of actual medication error due to wrong vaccine administered.  No reactions were noted.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   Follow-up information was received from a nurse by phone on 23-Apr-2019.  Suspect vaccine dosage information, concomitant medication details and information about adverse event was updated and changes made in the field and narrative accordingly.  Documents held by the sender: none.
Pt said her arm was slightly red and swollen around injection site and the reaction has gradually increased in size to about the size of a quarter today.
No symptoms or additional adverse effects reported; inadvertently received first dose in VARIVAX immunization series that was expired; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The pertinent medical history, concomitant medications, drug reactions or allergies were not reported. Concomitant therapy included sterile diluent (manufacturer unknown).   On 25-JUN-2020, the patient was inadvertently vaccinated with an expired first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R017768 and expiration date: 21-JUN-2020; strength, dose, route, and anatomical site of injection were not reported) for prophylaxis (expired product administered). No symptoms or additional adverse effects was reported (no adverse event).
In March 2000, the pt developed symptoms highly suggestive of shingles. The pt sought unspecified medical attention and a specimen was sent for analysis. Follow up data states patient was treated with acyclovir. Laboratory results of the lesion specimen were negative. It was reported the patient was doing well, recovering and most of the patient's lesions were resolved. Additional information has been requested.
Pain, swelling, redness and burning during the day next morning woke up shoulder to elbow extremely painful, swollen, red and burning hot to touch.  Nurse said I had to go to emergency room. I went they told me I had an infection from the vaccine.
Patient became, dizzy, lightheaded, and had to lay down. She had not eaten anything that day. She was given water, a small snack, and remained seated in office for about 10 minutes.
Two days after receiving vaccine went to get out bed and can hardly walk. felt like every place that i had injuries in the past the pain started coming back. felt like  broke my ankle and knee joints started hurting so bad. it was so severe that i schedule appointment and was given naproxen 500 mg. 60 tabs was on it for 2 weeks until the pain stopped.
PATIENT RECIEVED A MODERNA BOOSTER DOSE FROM A VIAL THAT HAD BEEN STORED AT ROOM TEMP AFTER BEING PUNCTURED FOR 77 HOURS.  WHEN CONTACTED ABOUT ERROR, PATIENT REPORTED SHE EXPERIENCED THE SAME SIDE EFFECTS FROM THE BOOSTER DOSE OF A FEVER AND SORE ARM STARTING ABOUT 12 HOURS AFTER RECEIVING HER DOSE.
Breakthrough case admission after 4 vaccines  Moderna 1/2/21 lot# 011L20A;  Moderna 1/30/21 lot# 012L20A;  Pifzer 11/9/21 lot# FG3527;  MOderna 6/30/22 Lot# 014B22A
A 36 year old female patient developed diarrhea, muscle pain, fever, nausea, lower extremity pain and palpitations after receiving RabAvert. On 06/22/04, the patient received her first dose of RabAvert, 1 ml intramuscularly. Her second dose was administered on 06/29/04. Past medical history was significant for gastroesophageal reflux disease (GERD). Concomitant medication included Protonix. The patient received her first RabAvert injection without adverse reactions. Twelve to fourteen hours after the second RabAvert dose, she experienced muscle pain, nausea, fever, diarrhea, pain in her lower extremity and heart palpitations. The same night, she took Ibuprofen and awoke the following day symptom free. The events resolved within 12 hours of onset and RabAvert therapy was continued.
26JUN95 administered MMR vax & 7JUL95 brought pt to clinic w/inc temp off & on   t102, generalized rash;
Headache, Myalgia, Fever, CHILLS, SORE ARM Narrative:
Red, raised bump. Circle in shape. Area was sore x 2 days and becoming better on lt arm where flu shot given. PPD admin same arm.
I have severe back ache and fatigue . did not  seek treatment. should I seek treatment??
4MAR93 pt recvd vax @ 845AM remained @ clinic till 1130AM; pt in no distress; late in PM on 4MARi3; pt w/sz admitted to hosp;
the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 ,single for covid-19 immunisation. Relevant medical history included: "faint" (unspecified if ongoing), notes: As a child , had a negative reaction when i got vaccination I fainted. I'm reminded the event. The patient's concomitant medications were not reported. The following information was reported: SPINAL PAIN (non-serious), BACK PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "the only adverse reaction I had was in my stomach headed toward my spine, lumbar 6 and 7 ached". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child experienced low-grade fevers X 2 weeks. Seen by MD and dx'd with otitis media. Child took 1 dose of amoxicillin and 1 dose of Tylenol and broke out with rash starting on arms and then legs and then it was generalized. Foster grandmother states rash escalated after giving Tylenol. MD dx'd as viral exanthem.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 at 09:30 as dose 1 , single (Batch/Lot number: unknown), in left arm, on 17Feb2021 at 09:30 as dose 2, single (Lot number: EN6200), in left arm and on 14Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20May2022 at 14:00 as dose 4 (booster), single (Lot number: 059M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing); "Enlarged prostate" (unspecified if ongoing); "restless leg syndrome" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Lung infection", start date: Apr2022 (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN, start date: 27Sep2021; ASPRIN; MAGNESIUM OXIDE, start date: May2018; NIACIN, start date: Dec2018; B12 [CYANOCOBALAMIN], start date: Dec2018; DOXYCYCLINE HYCLATE, start date: 26Apr2022, stop date: 01May2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Negative; (23Jun2022) Negative; (25Jun2022) Positive; (29Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient reported a rebound after completion of Paxlovid treatment. He finished the Paxlovid course on the morning of 20Jun2022 and had negative rapid antigen tests on 22Jun2022 and 23Jun2022. Symptoms (sore throat and night-sweating) returned on 25Jun2022, and he had positive rapid antigen tests on 25Jun2022 an 29Jun2022. He suspended taking Tamsulosin on 15Jun2022 per instructions from his urologist and resumed on 23Jun2022. The patient received other medications such as N-Acetyl Cysteine with Selenium & Molybdenum,  start date - May2020, lot number- 3225302 and Multivitamin, brand -, start date - Dec1979, lot number - 16934701.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
10/22/18: Pt seen in clinic by MD for WCC with normal exam. KINRIX administered in L thigh, MMRV adminsterd in R thigh. 10/25/18: Pt seen in clinic by another MD. Parents reported fever 102-103, redness, and lump at site starting 10/23/18. Received one dose ibuprofen at home, fever resolved and did not return. Exam reveals erythema to large portion of anterior L thigh, no fever. Dr. prescribed cephalexin 142.5 mg TID x 10 days and ibuprofen 86 mg Q6H PRN mild pain or fever and advised patient return in 1 week for re-check.
Mild local reaction only: red indurated 4 x 3 cm area at injection site.
PATIENT REPORTED FEELING HOTNESS RUNNING FROM ONE HAND AROUND THE BACK TO THE OTHER HAND. STATED GENERAL MALASE FOR THE REST OF THE EVENING, MISSED WORK. WOKE UP NEXT MORNING FEELING BACK TO NORMAL. NO FEVER OR CHILL. NO DIFFICULTY BREATHING OR CHEST PAIN. MUSCLE STRENGTH WAS EVEN ON BOTH SIDES. PATIENT THEN REPORTED THE NEXT DAY THAT HE WAS NOT FEELING GOOD AGAIN AND CONTACTED HIS PCP AND EXPLAINED. PCP STATED THE VACCINE WAS INTERACTING WITH THE VIRAL INFECTION HE HAS BEEN FIGHTING AND SENT HIM TO THE ER. WILL TRY TO GET FURTHER INFORMATION.
16 week Anatomy scan showed crembrem hyplasia amnd fluid in ventricles  that resulted in pregnancy termination
This spontaneous report as received from a pharmacist refers to a 65 year old male patient with none drug reactions/allergies. On 14-DEC-2014, the patient was vaccinated with one dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot number reported as: K011002 and expiration date: 07-NOV-2015). Concomitant medication included simvastatin (manufacturer unknown) 40 mg daily. On 14-DEC-2014, the patient experienced a 4 to 5 inch round, red, painful, raised area at the injection site after receiving ZOSTAVAX. It was reported that patient sought medical attention during unspecified doctor visit. No laboratory tests were performed. The outcome of 4 to 5 inch round, red, painful, raised area at the injection site was reported as not recovered. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 64-year-old female patient who received SHINGRIX for prophylaxis.  Co-suspect products included Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis and valaciclovir hydrochloride (Valacyclovir) unknown for cold sores. On 13th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and Influenza vaccine Quadrivalent 2018-2019 season. In March 2019, the patient started Valacyclovir at an unknown dose and frequency. On 13th September 2018, less than a day after receiving SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season and not applicable after starting Valacyclovir, the patient experienced loss of consciousness (serious criteria GSK medically significant), influenza-like symptoms and tiredness. In September 2018, the patient experienced pain, headache and feeling abnormal. On 11th March 2019, the patient experienced cold sores. On 13th March 2019, the patient experienced stye. On an unknown date, the patient experienced immunocompromised (serious criteria GSK medically significant). The action taken with Valacyclovir was unknown. On an unknown date, the outcome of the loss of consciousness, influenza-like symptoms, tiredness, pain and headache were recovered/resolved and the outcome of the immunocompromised, feeling abnormal, cold sores and stye were unknown. It was unknown if the reporter considered the loss of consciousness, immunocompromised, influenza-like symptoms, tiredness, pain, headache, feeling abnormal and cold sores to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. The reporter considered the stye to be unrelated to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. It was unknown if the reporter considered the stye to be related to Valacyclovir. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX on the left arm and Flu vaccine on the right arm. Within 12 to 24 hours after receiving SHINGRIX and Flu vaccine, the patient experienced flu like reaction which knocked her out and made her really tired. Less than a week after receiving SHINGRIX and Flu vaccine, the patient felt achy and had a headache and felt like she was hit by a truck. The patient felt really wiped out. All the symptoms were resolved with 3 days. On 11th March 2019, 179 days after receiving SHINGRIX and Flu vaccine, the patient also reported that she started to get a cold sore on Monday and she is taking Valacyclovir. One hundred and eight-one days after receiving SHINGRIX and Flu vaccine, the patient had a sty in her eye, which she was not relating to the vaccines but she might postpone getting the second shot because of her immune-compromised system. The reporter gave consent to call the physician for follow up.
A consumer report has been received. The report concerns a 6 year old, consumer of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. It was reported that FLUMIST was given twice in three days. The outcome of the event of FLUMIST given twice is unknown. The report was considered to be non-serious.
59 year old not immunocompromised male patient received Arexvy today, Oct 20th 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 59-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number A4945, expiry date 05-MAR-2025) for prophylaxis.   On 20-OCT-2023, the patient received Arexvy. On 20-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 59 year old not immunocompromised male patient received Arexvy today, Oct 20th 2023). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 20-Oct-2023 Pharmacist reported that the patient was turning 60 years in December. The reporter consented to follow-up. The patient received a dose of Arexvy at an inappropriate age, which led to inappropriate age at vaccine administration.
I experienced light-headedness only *when seated*  - This effect went away when standing and lasted only the morning.
no additional AE's were reported; first dose of PEDVAXHIB on 15MAR2023 and then their second dose on 29MAR2023; This spontaneous report was received from a nurse referring to a 2-month-old patient of unknown gender. Information about the patient's concurrent conditions, historical conditions, concomitant medications and drug reactions/allergies were not reported.  On 15-MAR-2023, the patient was vaccinated with first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (strength, lot #, expiry date, route of administration, and anatomical site were not provided) for prophylaxis. On 29-MAR-2023, the patient was vaccinated with second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (strength, lot #, expiry date, route of administration, and anatomical site were not provided) ) for prophylaxis due to the patient's previous appointment notes were carried over to her current appointment (inappropriate schedule of product administration). No additional adverse event (AE) reported (no AE).
I had all the symptoms were related to low hemoglobin. So I tests done. Went to ER -  The day before my transfusion - I had Low hemoglobin so on May 28t, I had a blood transfusion; and had another blood transfusion - on June 16th.  Apparently, I have some kind of bleeding so they have to continue to do more testing.
Stomach pain; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.