chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a 61 year old female patient. The patient had no pertinent medical history, concomitant medications and did not have known allergies. On 29-JUL-2016, the patient was vaccinated with ZOSTAVAX, 19400 Plaque Forming Unit (PFU), subcutaneous. Dose, lot # and expiration date were not provided. On an unknown date in 2016, after vaccination, the patient experienced redness and swelling at injection site. The reporter stated that the patient was sought on 17-AUG-2016 and that the redness and swelling were gone (recovered), but "there was a round patch of darkened skin at the injection site". No treatment was given for the events and laboratory test were not performed. It was not a product quality complaint involved. The outcome of darkened skin at the injection site was reported as recovering. The causality assessment between the events and the suspect therapy was not reported. Additional information has been requested.
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient.  Neither medical history nor concomitant medications have been reported.  On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine.  The vaccine had an expiration date of March 2008.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication that occurred shortly after the product expired.  Follow-up information was received on 09-APR-2009:  Product Complaint Investigation results.
In November, 99, the pt experienced atypical varicella with a few small vesicles, mainly erthematous papules. No further information is available.
Cold sore .  Very aggressive.  Course was about 7 days.  Then  Felt first stages of recurrence of another cold sore 10 days after second shot.  Have over the counter medicine on hand so seemed to stop it.  However, I only get cold sores less than once a year so timing suggests a connection.
Light headed immediately afterwards; Loss of body function; Disoriented; Sleepy; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 30Jul2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin, sulfur and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not receive any concomitant medications. On 30Jul2021 at 16:30, the patient felt light headed immediately afterwards. She also experienced loss of body function, felt disoriented and sleepy. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events light headed immediately afterwards, loss of body function, disoriented and sleepy were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Fever & local rxn; 4th shot, no noted problems w/previous injects;
Rash all over the body that causes itching more intensely on the legs, arms, and hands; Inflammation of the lips and loss of sensation in the lips, and inflammation of the hands.
I developed a black eye the day after the shot. I felt moderately sick as has been reported for others after the second dose, otherwise no other symptoms.
vial put in refrigerator 11/1/21. used beyond 31 days.
Our hospital has had 4 patients who developed an unuseal degree of pain at the injection site after receiveing pneumococcal vaccine SQ. The most recent patient was also reported as having some tissue breakdown at the injection site.
HOT FLASHES; RUNNY NOSE; TINNITUS; JOINT PAIN; LIGHT HEADACHES; MORE TIRED; This spontaneous report received from a consumer concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820096 expiry: UNKNOWN) dose was not reported, administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-AUG-2021, the patient experienced hot flashes. On 15-AUG-2021, the patient experienced runny nose. On 15-AUG-2021, the patient experienced tinnitus. On 15-AUG-2021, the patient experienced joint pain. On 15-AUG-2021, the patient experienced light headaches. On 15-AUG-2021, the patient experienced more tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headaches, more tired, joint pain, tinnitus, runny nose and hot flashes was not reported. This report was non-serious. This case, from the same reporter is linked to 20210832500.
Moderna dose 0.5mL IM administered into left deltoid by another vaccinator, on 01/18/21 @1241. No adverse reactions occured at time of injection. Cargiver at the time was under age for vaccine(17yrs and 5 months)will not be 18 y/o until 6/30/21. He is a Volunteer per consent form. Yestrday, 2/23/21 came to clinic to get 2nd dose Moderna when we was flagged for 1) age 2) type of vaccine received and 3) parent needed to be present. I requested for parent to be present. I apologized to caregiver once parent was present but declined the request for vaccination due to age. Provided education as Moderna is recommended for 18yrs and older, Pfizer is for 17yrs and older.
Did not received 3rd dose; 1st dose received on 18-sep-19 and 2nd dose on 14-sep-20; 2nd dose received at the age of 13 years; 1st dose received at the age of 12 years; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 16-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   On 14-SEP-2020, the patient received the 2nd dose of Twinrix. On 18-SEP-2019, the patient received the 1st dose of Twinrix. On an unknown date, the patient received the 3rd dose of Twinrix. On 18-SEP-2019, not applicable after receiving Twinrix and Twinrix and an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 1st dose received at the age of 12 years). On 14-SEP-2020, the patient experienced inappropriate age at vaccine administration (Verbatim: 2nd dose received at the age of 13 years) and drug dose administration interval too long (Verbatim: 1st dose received on 18-sep-19 and 2nd dose on 14-sep-20). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Did not received 3rd dose). The outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration, drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter wanted to know guidance on Twinrix dosing schedule. The reporter reported that the patient moved to here and both the physicians stated that the patient did not need to receive another dose of Twinrix vaccine, but the reporter stated their school district requires students to have three doses. The patient did not receive the 3rd dose of Twinrix as per the vaccination schedule, which led to incomplete course of vaccination. The patient received 2nd dose of Twinrix late than recommended time frame, which led to lengthening of vaccination schedule. The patient received Twinrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
lost their smell; 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 parent.  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: ANOSMIA (non-serious), outcome "unknown", described as "lost their smell".  Additional Information: just need to let you guys know that both of my kids got their vaccination the 5 to 11:00 and they lost their smell I didn't know if you guys was aware that that was probably a side effect of it I didn't know if you needed to let the FDA know about it  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101883364 for Same reporter / drug / event, different patients.
Gave a dose of COVID vaccine without diluting it first.  Discussed fever and possible side effects. Unable to reach family since vaccine given.
A non-serious spontaneous report of pneumonia has been received form a consumer/father concerning his 25-month-old daughter, subsequent to FLUMIST. The patient's medical history and concomitant medication were not reported. The patient received FLUMIST on 16-Sep-2009. After receiving FLUMIST, the patient experienced a fever of 102 degrees Fahrenheit, runny nose and cough on an unspecified date. On 18-Sep-2009, she was experiencing a fever of 104 degrees Fahrenheit and was taken to her doctor for evaluation. Per the patient's father, his daughter was diagnosed with pneumonia. She was at home at the time of the report. The pneumonia and fever were ongoing. The outcome of runny nose and cough were not reported. All follow-up have been completed per company SOPs.  No further information is available.  10 Mar 2010.
After my second booster vaccine, muscle from armpit to my left breast has been extremely sore since the vaccine was administered however, the pain has slowly dissipated after. My fever went up to 103.2F and slept it off took Tylenol and slept. I had some strange chemical taste coming from my mouth and gas from my chest. I also had an ear infection that started with sharp pains on the sides of my face. The pain shot up from my teeth to my eyes as well. The next day it moved to just one side, and it goes from my ear to my eye. I do notice that my fever has gone down to 99.7F and Ear infections seem to be the major lingering issues. In the past vaccinations I have had somewhere between a few weeks post vaccines a herpes simplex virus outbreak as well.
This spontaneous report as received from a pharmacist via agency refers to a 68 year old female patient. The patient's relevant medical history and past drug history were unknown. On 21-DEC-2014 the patient was vaccinated with ZOSTAVAX (lot# and expiration date not reported), a "standard dose" one time in the left arm. Concomitant medications were unknown. On 23-DEC-2014, the patient noticed golf ball sized swelling and redness at the site of injection. The patient had not had any testing or received any treatment for the golf ball sized swelling and redness. As of 23-DEC-2014, the patient would not continue on the ZOSTAVAX as it was a "one time" injection and had not recovered from the gold ball sized swelling and redness at the site of injection. The events were not potentially serious. Additional information has been requested.
I broke out with a rash and my stomach, chest and neck within 24 hours of the injection.  I had a severe headache within 24 hours of the injection.  On 10/17/2022 I began having severe pain in my lower left area of my pelvis.  The pain continued to persist through out the week.  It felt as if I was getting stabbed in my pelvic area.    I finally went to the Emergency Room at a local HCF on 10/23/2022.  After having multiple tests I discovered that I had an ovarian cyst that had grown exponentially since my last ultrasound.  On 10/25/2022 my period started and lasted approximately 4 days.  This was not within my cycle.  I had the second injection of the Phizer shot on 11/2/2022.  On 11/4/2022 my period again started and lasted approximately 7 days.  Keep in mind I am on the birth control pill and had just had a period on 10/25/2022.  I have NEVER been irregular.  My period again started on  12/6/ 2021 and lasted until 12/15/21.  My period again started on 12/28/2021 and ended on 12/31/2021.  My period again started on 1/24/2022 and last until 2/3/2022.  My period again started 2/15/2022 and lasted until 3/2/2022.  THIS IS NOT NORMAL
Itchy and redness under inj site. Tightness in (L) jaw slight fever. Itchin started day after injection.
I awoke on 2/26 with tingling in my left arm with no other explained cause. I also had muscle twitching in my left hand. I had heard the vaccine might be able to cause tingling and twitching so I wanted to report it.
On this day I was assigned to give Covid vaccinations. Per procedure, the PT goes to the first tent where their age and status is verified then they are sent to have their vaccine administered. Once they arrived at the tent, I administer the vaccine. We have been told once they arrive at our section they have been verified and are clear for the vaccine. Due to this policy I did not check the age and status of the PT. Moving forward I will double age and status of all patients coming through my line. PT did not report any complications or AE from the vaccine. PT was 17 years of age
Swelling/redness/itching of left arm x 5 days. Referred pt to PCP.
Colitis ulcerative aggravated; Shaking of hands; Feeling unwell; This is a solicited report from the marketing program received from a non-contactable consumer (patient) based on information received by Pfizer  (manufacturer control number:21K-163-3860062-00).   A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at (1 in 2 weeks), then subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, weekly (1 in 1wk) for moderate to severe ulcerative colitis.  Medical history included colitis ulcerative aggravated (moderate to severe ulcerative colitis) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  On unspecified date,  the patient experienced colitis ulcerative aggravated with outcome of recovering, feeling unwell in 2021 and shaking of hands on unspecified date; both with outcome of not recovered.    The reporter's causality for events feeling unwell, colitis ulcerative aggravated and shaking hands with suspect drug COVID-19 vaccine were not reported.   The reporter's causality for the event not feeling well was not provided. The reporter's causality for the events ulcerative colitis flare up and shacking hands with adalimumab (HUMIRA) was a reasonable possibility.   The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The reported events were assessed as unrelated to suspected drug BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection),  Case will be reassessed once new information is reported.
0900pm on 3-9 to 600am on 03-4. Bad shaking , bone pain and joint pain. Took Advil at 6 am  on 3-4 that help. But lost sense of taste till 3-15.
On 3/6/00, the pt developed 20-25 lesions on her face, neck, upper back, chest, stomach, and injection site. The pt sought unspecified medical attention. Follow up information states the patient was prescribed Benadryl and Zovirax. The patient recovered on 03/12/2000.
2 weeks of terrible headache, stiff neck and fatigue, decreasing in the third week, worse I have ever had in my 62 years. Not sure if I should report - wanted to "log it" if it helps the experience database.   Warnings of a "couple of days" were a way understatement in my case. Second shot went OK, without any issues. I was very hesitant before second shot, almost did not show up.
Had 3rd COVID Pfizer Vaccine on Thursday 9/30/21. Starting 24 hours after vaccination. Had chills, fever, N/V, HA and body aches.
have it for 14 months/ Have it on left stomach, hip, back area; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: have it for 14 months/ Have it on left stomach, hip, back area). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023 The patient did with the first booster shot. The patient had it for 14 months so far, no joke, had it on left stomach, hip and back area. The follow-up would not possible as no contact details were available.
Patient had a large stroke. Seizure on 01/30/2021 after first dose of Pfeizer vaccine on 01/29/2021. Patient was 74 years old at the time she received the vaccine.
Pt was administered an expired dose of Havrix on 12/12/2022. Lot was noted to have expiration of 06/18/2022. MD informed immediately and patient called and informed.
Arm slightly swollen. Sore to touch  Extremely tiredness  slight headache in frontal lobes Took Tyninol to aleve headaches  no need to go to doctor  at this time  if symptoms persist in 3 days. I will
Symptom onset was 04/29/2022, SOB, congestion and chest pain/pressure. Admitted to hospital 04/30/2022.
No adverse event; I don't think the needle went into my muscle/Patient was pretty sure that received the vaccine at skin level but not intramuscularly/it pinch only patient's skin; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I don't think the needle went into my muscle/Patient was pretty sure that received the vaccine at skin level but not intramuscularly/it pinch only patient's skin) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I don't think the needle went into my muscle/Patient was pretty sure that received the vaccine at skin level but not intramuscularly/it pinch only patient's skin). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I don't think the needle went into my muscle/Patient was pretty sure that received the vaccine at skin level but not intramuscularly/it pinch only patient's skin) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant medications details were not reported by the reporter. Patient did not think the needle went into muscle, Patient did not feel any soreness and was pretty sure that she received the vaccine at skin level but not intramuscularly and it pinch only skin. Patient thought that because she was not having any side effects and wants to know if patient was protected. Treatment details were not reported by the reporter.
administered after the published expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered after the published expiration date) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1 and Dose 2 was Pfizer.). Past adverse reactions to the above products included No adverse event with Pfizer.    On 05-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. The vial did not undergone any temperature excursions. There were no adverse events reported by the patients after the administration error. No treatment information was reported.
Pt had a PNEUMOVAX-23 vaccination. Her arm became painful, lost strength and poor mobility. She saw an MD. It improved and now is back to normal.
Patient received PNEUMOVAX 23 in (R) deltoid on 11/7 pt had onset of redness down to wrist, swelling, warm to the touch and tenderness/fatigue in (R) arm-went to walk in clinic diagnosed w/phlebitis.
Employee experienced headache, fever, and body chills that began several hours after administration of the vaccine. She also reported injection site soreness, redness, and swelling. She recovered from the adverse effects by the 3rd day post-vaccination.
pt cried from 945 AM to about 530PM; frequent periods of cont crying; cry was higher pitched than nl;
Chills, fatigue, body aches, headache and nausea for approximately 8-10 hours starting the next morning
During previous injections and/or intranasal administrations had allergic symptoms around the area of administration and fallen ill. Overall minor effects.
pt recv vax 29SEP95 & 3DEC95 pt exp pneumonia sx;on 6DEC95 pt was hospitalized w/pneumonia;pt recovered from pneumonia;
Day 1- sore arm. Day 2&3- aches and chills. Day 4, 5 & 6- Diarrhea and stomach pain
redness (approximately 3-4" in diameter 7/11/19). Swelling - has decreased since date of injection pt has used ice  pain intermittent itching  Patient reported ADRS and RPh contacted PCP who scheduled apt 7/12/19 @ 10 AM MD office will follow up with pharmacy if patient allows. Per practice assistant in fear of privacy violation
PCV was ordered, but IPV was given by mistake on 3/30/16. A week later on 4/6/16 was seen at ER for respiratory distress.