chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The caller's wife mentioned that 2 of her friends got Shingles after the second; This report from a Pfizer sponsored program support. A non-contactable consumer. reported that a 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Medical history included, thyroid cancer from 2009 to an unknown date. The patient's concomitant medications were not reported. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration on an unknown date (Batch/Lot number : Not provided) as dose 1, single for covid-19 immunisation. On an unknown date, the caller's wife mentioned that her friends got shingles after the second. It was reported that the caller's wife mentioned that her friends got Shingles after the second shot and didn't want to take it. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC same product/reporter, different patient/event
dizziness; tachycardia; fatigue; This is a spontaneous report from a contactable other health professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced reported dizziness, tachycardia, and fatigue after taking the COVID vaccine on an unspecified date. The patient's symptoms didn't seem severe.   Information on the lot/batch number has been requested.
Information has been received from a physician concerning a currently 28 year old female patient with history of "abnormal PAP smear" who at age of 26 year old completed her GARDASIL series. It was reported that the now 28 year old patient, returned to the office for her 6-8 post partum check up and her "PAP smear results" were abnormal. It was unknown if the patient received any treatment or if her PAP smear results ever returned to normal after the first abnormal result from years ago. At the time of the report the patient's status was not specified. The patient sought medical attention by an office visit. Additional information has been requested.
5/5/10 redness, swelling about 4" toward front and lower arm (biceps area).
only the liquid portion of Menveo was administered; only the liquid portion of Menveo was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA903A, expiry date 31-JAN-2024) for prophylaxis.   On 02-AUG-2023, the patient received Menveo. On 02-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only the liquid portion of Menveo was administered) and inappropriate dose of vaccine administered (Verbatim: only the liquid portion of Menveo was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 The reporter was a medical assistant. The reporter stated that patient was administered with only liquid portion of Menveo. The reporter stated there was one powder vial left in the box due to which the event was discovered. The reporter was unsure to which patient the incomplete dose was given. The patient received only adjuvant of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Fatigue  Muscle or body aches  Headache  Congestion or running nose
Pt received shot at about 3:24 pm, pt had fever at around 12 am that continued until morning. pt treating with tylenol q6h, but fever reoccurs. Pt also had bad chills and body aches post first dose.
The patient did not experience any symptoms; patient was vaccinated with improperly stored varivax; This spontaneous report as received from a medical assistant refers to a 3 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included sterile diluent. On 03-DEC-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route of administration and anatomical location were not reported) of lot # S004119 is an invalid lot number, expiry date reported as 11-FEB-2021 for prophylaxis (product storage error). The patient did not experience any symptoms. The outcome of product storage error was unknown. The temperature excursion for varicella virus vaccine live (oka/merck) (VARIVAX) was reported as -9 degrees Celsius (C) to 8 degrees Celsius (3.3 C) for 53 hours. There was no previous temperature excursion reported. Data logger was involved. No product quality complaint (PQC) was associated with this report.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513-1911USA011629:
Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen; Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen) and INJECTION SITE SWELLING (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced INJECTION SITE ERYTHEMA (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen) and INJECTION SITE SWELLING (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen). At the time of the report, INJECTION SITE ERYTHEMA (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen) and INJECTION SITE SWELLING (Received my first dose on September 1. Now on September 9, the arm with the injection site is red and swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
my arm is quite sore; This is a spontaneous report from Pfizer sponsored program. A contactable female consumer (patient) reported for herself.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration on 22Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included back pain from an unknown date and unknown if ongoing. The patient's concomitant medications included tramadol for back pain. On an unspecified date in Feb2021, the patient experienced my arm is quite sore. The patient was querying about how long she needs to wait before she could take Tylenol or Tramadol for pain. The patient reported "my arm is quite sore" and reported that she usually takes a tramadol daily for a history of back pain. She asked when it would be ok to take the medication. The clinical outcome for the event was unknown.  No follow up attempts are possible; information on Lot/batch number cannot be obtained.
Pt states high temperature and muscle aches. Severe enough pt was in bed 2-3 days. Does not remember how high temperature was.
Patient received PENTACEL 10/06/17. IPOL administered today 10/19/17 in error, 13 days after receiving PENTACEL. Not aware of any adverse advent. Vaccination given in error.
RINGING IN EARS; PAIN IN EARS; DIZZINESS; INAPPROPRIATE DOSE OF DRUG ADMINISTERED; INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION; PSORIASIS FACIAL; INJECTION SITE BRUISING; DEVICE ISSUE; HEADACHE; INJECTION SITE SWELLING; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced ringing in ears, pain in ears, dizziness, inappropriate dose of drug administered, inappropriate schedule of drug administration, psoriasis facial, injection site bruising, device issue, headache, and injection site swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ringing in ears, pain in ears, headache, dizziness, inappropriate dose of drug administered, inappropriate schedule of drug administration, psoriasis facial, injection site swelling, injection site bruising and device issue was not reported. This report was non-serious.
sweating; large circular rash; joint ache from shoulder to hands; redness; nausea; sore arm; itchy at the injection site; A spontaneous  report was received from a consumer concerning a 51 year old, female patient who experienced itching at the injection site, redness, sore arm, large circular rash, joint ache from shoulders to hands, nausea and sweating following their first dose of Moderna's COVID-19 vaccine.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included aspirin.  On 22 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (lot number 011J20A, Expiry date: 11-MAY-2021) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 22 DEC 2020 the patient experienced itching at the injection site right after the administration, and then off and on.  On 04 JAN 2021 she began experiencing redness, itching, sore arm, large circular rash, joint ache from shoulders to hands, nausea and sweating. No treatments have been given during this event.   No treatment medications were reported.   The events, itching at injection site, redness, itching, sore arm, large circular rash, joint ache from shoulders to hands, nausea and sweating were recovering.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. Itching at the injection site, redness, large circular rash, joint ache from shoulders to hands and nausea are consistent with the known safety profile of the vaccine.
Pt fainted on the premises approx 10 minutes after receiving the vaccine. Pt was lying the on the floor and a bump or cut was observed on the back of the head. Pt remained prone and alert until paramedics arrived 10 minutes later. After evaluation by paramedics, pt was moved to an upright position on the floor and was alert. Two minutes after he was moved to a seated position in a chair, the patient lost consciousness and experienced some type of seizure for 15-20 seconds.  He regained consciousness and seemed less alert than before. Paramedics transferred patient to a g
Moderna COVID-19 Vaccine EUA I received the vaccination around 2:45 pm and felt mild soreness at the injection site within a few minutes. At around 4:00 pm, I felt mild joint pain in my right ankle which worsened to mild/moderate joint pain in my left elbow/wrist + both ankles/knees, so I took an extra strength acetaminophen (500 mg) around 4:30 pm. My joint pain subsided, and I began to feel fatigued around 5:00 pm. Mild chills began around 9:30 pm, and joint pain at the same sites resumed around 10:00 pm. I went to bed around 12:00 am with moderate chills, mild joint pain, and mild pain at the injection site, but I awoke around 12:45 am with slightly worsened chills, joint pain, and pain at the injection site. I took another extra strength acetaminophen and was able to sleep for the rest of the night. I woke up at 9:00 am with no symptoms.
Moderate itching on palms of both hands and wrists.  No visible rash. Got worse during the day.  Anti-histamine and Advil did little to help with the itch.  By 6:00 AM 11/19/2009, rash appears at itch site, anywhere on body: arms, legs, eye-lids, ears, especially on palms of hands and soles of feet. Itch sites change frequently. Prednisone prescribed by Primary Care Physician, first dose (6 4mg tabs) taken at 12:00PM 11/19/2009, with little relief.
INJECTION SITE ARM SORENESS; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site arm soreness. This report was non-serious. This case, from the same reporter is linked to 20210424282.
experienced that joint pain; from his very initial Pfizer Covid shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "experienced that joint pain; from his very initial Pfizer Covid shot".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient experienced flu like symptoms, muscle aches, chills, fatigue, etc. about a day after receiving the vaccine. He did not experience these symptoms with the first dose of the vaccine.
chills; sweats; rundown; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), HYPERHIDROSIS (sweats) and MALAISE (rundown) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), HYPERHIDROSIS (sweats) and MALAISE (rundown). At the time of the report, CHILLS (chills), HYPERHIDROSIS (sweats) and MALAISE (rundown) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment details reported. no concomitant products reported.
This is a 65-year-old male with past medical history of hyperlipidemia, morbid obesity, CLL on immunotherapy as a part of clinical trial, on chronic antiviral acyclovir and antibiotic Bactrim as a part of the clinical trial, immunocompromised status.  He came to the hospital with a chief complaint of cough and shortness of breath over the last 8 days.  Initially the symptoms started on Monday.  He tested positive for COVID-19.  He got exposure from 1 of his friends who is admitted in the hospital.  The patient also had some subjective fevers and chills.  He did have some nausea but denies any vomiting.  Denies any abdominal pain, chest pain, burning or painful urination, diarrhea.  Patient was vaccinated with 2 doses of Pfizer.  Last dose was in June.   Patient's wife also had very mild symptoms but she is doing very well and has recovered.
Patient started feeling light headed and mom notified pharmacy staff while waiting in our waiting room around 3:32 pm. We got him a glass of water and fruit snacks and a cool towel. He looked pale when I arrived in the waiting room. We sat with him as he did not want to lay down, his color returned. He felt better and mom took him home at 3:42pm.
5" red warm area in upper left arm from day 3 to 5 after injection, red spot and itching  returned day 9 after injection and is still present along with full left arm pain and flare of rheumatoid arthritis
Eleven days after received vaccine, looked like pimple at site. Right thigh with 3-4 small vesicles present with redness.
Patient received the menquafi vaccine to her right deltoid on Thursday afternoon, 7/6/23. Later that evening at home she developed a headache, nausea and her throat felt weird. Her entire upper right arm was red, swollen, warm and painful.  Mom also reported an egg size lump at injection site. The next day it was worse. She was seen Saturday 7/8/23 at the clinic for large area of erythema of right arm with swelling and increased warmth. The area was marked with blue surgical pen. She was prescribed an antibiotic and steroid suspension along with Benadryl.  Patient was seen 2 days later. The area was less red but the area itself remained the same. She will continue to use ice packs to area and finish the antibiotics and prednisolone. She will return if symptoms worsen or fail to improve. Local DOH was called to report and given info to report here.
She started feeling sick 2 days later and she tested positive for Covid-19; She started feeling sick 2 days later and she tested positive for Covid-19; This is a spontaneous report from a contactable consumer. This consumer reported that a female patient of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number- not reported), via an unspecified route of administration on 05Feb2021 at single dose for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. The patient feeling sick 2 days later on 07Feb2021 and she tested positive for covid-19. She already tested negative for Covid-19 on an unspecified date Feb2021. Her second dose was scheduled on 26Feb2021. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
4 Hours after injection the patient reported an "egg shaped hard spot". 6 hours after injection this area grew to 4x5 inches. Patient took 2 Tylenol 500mg at this point. The area became swollen and red hot at this time. 7 hours after injection the area grew to 6x6inches. 9 hours after injection the area began itching. At 4:30AM the next day, the entire arm was swollen from the shoulder to the elbow. Patient was given a "steroid shot at urgent" care this morning and a Medrol pack to follow the next day. Patient was also given hydroxyzine 10mg.
Sever flu symptoms for 3 days after second inj 01/28/2021.  First dose 12/28/2020. Then profound fatigue and shortness of breath for approx 2 mos
Pt presented to EMS with a complaint of tingling in the back of his throat. No past medical history reported. Allergies to NSAIDs. Pt was taken into hallway where his vitals were obtained. Vitals within normal limits.  Airway was assessed, no tongue/airway swelling noted. PT was given  water, he was able to drink without difficulties. He was asked again how he was feeling and he stated he was feeling better and the tingling in his throat had gone away. He stated he felt good enough to leave. After his observation time was up he was assisted to the exit.
Patient noticed severe R breast and side pain on 1/1/2021.  She saw her family practice provider Dr. on 1/7/2021 for pain and breast swelling. Over the weekend she was seen in the Emergency Department for increased R breast swelling and severe pain. She was treated with antibiotics and has follow up appointments scheduled.
Medication error; second dose given too soon.  Patient failed to disclose that he had received the first dose of Moderna COVID vaccine on 1/3/21.  Marked no on the screening tool and answered no to verbal questioning about previous COVID vaccinations.
Menactra vaccine admin inadvertently. No symptoms (adverse events) noted except cranky at 2:15PM. No fever, increased appetite.
Lightheadedness; Feeling of losing her balance; Body aches; Extreme Chills and can not get warm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness), BALANCE DISORDER (Feeling of losing her balance), MYALGIA (Body aches) and CHILLS (Extreme Chills and can not get warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced DIZZINESS (Lightheadedness), BALANCE DISORDER (Feeling of losing her balance), MYALGIA (Body aches) and CHILLS (Extreme Chills and can not get warm). At the time of the report, DIZZINESS (Lightheadedness), BALANCE DISORDER (Feeling of losing her balance), MYALGIA (Body aches) and CHILLS (Extreme Chills and can not get warm) outcome was unknown. Not Provided
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On an unspecified date, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, he was treated by a physician for the onset of severe vesicular wash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown at the time of the report. Causality assessment was related. Additional information has been requested.
Information has been received from a registered nurse referring to male patient of unknown age.  The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (dose and route unknown, lot # M035486, expiration date: 05-JUN-2019) for prophylaxis. The vaccine was stored in -1.5 degrees Celsius for 2 hours 53 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax 14SEP95 & 4-5hrs p/vax pt was feeding, started to choke;became cyanotic, eyes glazed over;taken to ER;had fever of 101.5;It was felt that had a poss sz & was admitted;lab eval revealed 16 white cells in his CSF, blood sugar 30