chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 12/2/03 concerning an unspecified number (approximately 5 to 6) vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinees inadvertently received Fluvirin 0.5ml IM. The vaccine did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/20/04: A follow up report was received from a health care professional concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 11/25/03. On 11/25/03 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. No follow up pending, all information received.
Left arm pain started soon after 2nd dose and became progressively worse.  On 4/30/21 I woke up with arm, chest pain, and I was exhausted.  Went to emergency where I was admitted and then transferred to hospital, by ambulance to their  Cardiac unit.  The next morning Dr performed heart catheter surgery and implanted 2 heart stents at hospital.  After this initial episode I have had several episodes of severe and painful inflammation in different parts of my body.  Most debilitating has been my hands and arms which have experienced episodes of swollen, angry red skin where just moving it hurt.  My foot became so inflammed that I was in bed for 3 days and the sheet could not be on my foot because it hurt so much.
Moderna Booster vaccine was administered at 0.5ml. Should have been 0.25ml.  No adverse reaction- no treatment needed.
Around 12 pm on 04/10/2021, I started feeling fatigued.  At around 6 or 7 on 04/10/2021, I started having muscle aches and joint pains all over my body.   I did not really do anything that day.  I was just worn out it seemed.   I did not sleep very well that night as I was hurting.  I got up on 04/11/2021 still in pain.  I took a shower and got ready for church.  I took some tylenol after breakfast to see if it would help with the pain which after about 45 minutes to an hour I was not hurting as bad.  I did fine throughout the day on 04/11/2021.  I did that evening around 6 or 7 started with the aches and pains again.  I took some more Tylenol.  I did have a pain on the top of my shoulder which hurt all day no matter what I took.  On 04/12/2021, I got up feeling better, but I still had the pain in my shoulder.  I went to work, and I noticed around 1ish that I had a knot on my neck.  It was painful when touched, and it hurt when I moved my head or my arm.  I ended up going to the doctor just to make sure that it was nothing.  He did tell me that it was a side effect but an uncommon one.  He told me to take Ibuprofen 600 mg until the swelling went down.  As of today, 04/14/2021, the knot is still there, but it has gone down in size.
This spontaneous prospective pregnancy report as received from a Licensed Practical Nurse refers to a 27 year old female patient with no pertinent medical history or drug reactions/allergies. On an unknown date in 2013 the patient was vaccinated with her third dose of GARDASIL (lot # 0518AE, expiration date 21-NOV-2014, 0.5ml, intramuscularly) for vaccination while she was pregnant. There was no concomitant medication. The patient became pregnant with LMP of 12-JUL-2013 and EDD of 18-APR-2014. The patient's date of conception estimated on 26-JUL-2013. The pregnancy outcome was unknown. No congenital anomaly was known of at the time of the report. Additional information has been requested.
Patient weight 4.553 kg, 50 mg dose of nirsevimab ordered by pt received 100 mg  dose by mistake.  Event happened ~4 hours prior to this report.  So far no symptoms reported.  Parents instructed to follow up if any symptoms or concerns.
Fever 99.7F,Headache, muscle soreness, tiredness/fatigue , sleepy, fast heartbeat (60 normal,to 85-90). Sore throat after 30 hours
Patient received their first dose of Moderna and was being observed for 30 minutes as patient know to have severe allergies requiring an Epi pen as needed.  Shortly after receiving the injection, patient complained of shortness of breath, urticaria, O2 sats of 93%.  Benadryl 50mg and Solumedrol 40mg given IM and transported to the emergency room via 911.   Patient has a follow-up apt on 11-15-21
Vocal cord effected by rash causing a rough raspy voice; Rash on upper torso, arms, and legs; Itchiness at injection site; Red spots at injection site; Swelling at injection site; Hot to touch at injection site; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Covid arm), DYSPHONIA, INJECTION SITE WARMTH, RASH, and INJECTION SITE PRURITUS in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ALENDRONATE SODIUM for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE REACTION (Covid arm), INJECTION SITE WARMTH, INJECTION SITE PRURITUS, INJECTION SITE ERYTHEMA, and INJECTION SITE SWELLING. On 01-Mar-2021, the patient experienced RASH. On 02-Mar-2021, the patient experienced DYSPHONIA. On 27-Feb-2021, INJECTION SITE REACTION (Covid arm), INJECTION SITE WARMTH, INJECTION SITE PRURITUS, INJECTION SITE ERYTHEMA, and INJECTION SITE SWELLING had resolved. On 02-Mar-2021, DYSPHONIA had resolved. On 04-Mar-2021, RASH had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received SHINGRIX (batch number L9CS4, expiry date unknown) for prophylaxis. On 11th September 2018, the patient received SHINGRIX. On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter agreed to be contacted for follow up.
Patient was administered the Moderna vaccine.  patient is 15 years of age and should have received Pfizer vaccine. No adverse events or symptoms reported by patient.
Broke out into hives from head to toe about 3.5 hours after receiving first dose. They itched mildly. Took max benadryl and hives eventually went away.
Fast heartbeat; Nausea; Felt faint. Rash at injection site and on chest, back, arms on 10/28/15.
I went to get a flu vaccine at my local pharmacy clinic. I asked for the flublok quadrivalent vaccine because I had read that it was better suited for people with allergies, and who are prone to have allergic reactions. However, the nurse practitioner insisted that I get the flucelvax quadrivalent flu vaccine instead. She told me that she and her children had received the same vaccine, and that they didn't have a bad reaction to it. She told me that both vaccines were very similar. I thought it was odd that she just didn't give me the vaccine I asked for, but I didn't see any reason to press the matter. So I agreed to have the flucelvac quadrivalent vaccine which she kept insisting on. After she administered the flu vaccine to me I left. I didn't live far from the store. I started to feel tingling all over my body about 30 to 45mins after I received the flu vaccine.  When this started happening I thought that I must be having a mild reaction to the vaccine. The tingling and itching lasted all day. I was still itching some the next day, but this time I noticed that my left hand, on the arm that I received the injection was really really sore, and weak. My left arm muscles also ached and felt really fatigued. The muscle ache in my left hand, and arm lasted all day. Later on that night my entire body was experiencing muscle aches, and muscle fatigue. When I went to bed that night I took a Benadryl and went  to sleep. The next day the itching I had experienced had greatly diminished, but I was still experiencing muscle aches and fatigue all over my body. I have to lift heavy things at work, and for the past few days it has been difficult to do  so because of the muscle fatigue I've been experiencing. I am writing a report today, 10/17/20, because it has been a week since I received the flu vaccine, and I am still experiencing mild itching, muscle aches, and muscle fatigue.  I have never had such a bad reaction from receiving a flu vaccine before!
Multiple immunization administered 3/19/12. Body rash has now developed over the past 24 hrs. Examined in office 3/30/12. Copy of examine is attached. Rapid strep negative. ATARAX Rx 1D. DDX: Roseola secondary to MMR vaccine.
she started with redness around the eyes and then nose and mouth. Each day got worse and worse with fever and rash all over the body down to the thigh area. Mouth and ears started peeling, then eventually whole body peeled.
24hr p/vax lt deltoid pt noted pain @ inj site & 3 red lines;APAP for fever;patch sl warm & tender;
Mtr: stating (L) thigh hot to touch, with redness, tenderness and firmness at injection site the day after shots were received. Applied ice pack and given TYLENOL. Improved at follow-up 2 days post - vaccination - no warmth, mild redness lat to injection site about 3 cm diameter about 2 cm firm site nodule.
Patient experienced lower back pain, sharp pain in arms, hands, and thighs, plus nausea and vomiting.
Patient received the Covid-19 vaccine. She reports symptoms of  I have observed : Patient c/o of feeling light headed and dry throat. Brought to the observation area and VS were as follows: HR 90-95 Pulse ox 100% BP 150/110 C/O feeling warm. States that BP is normally 110-115/70-80's. No difficulty breathing, alert and oriented to person, time, and place.   Repeat Blood pressure 145/104 and heart rate in the 70's.  Oxygen saturation maintained at 100% on room air.    Treatment/intervention Pt was monitored, VS taken approximately every 10 min. Pt given water and juice.  1515: HR 91, BP 150/110, Oxygen Sat: 100% 1525: HR 70, BP 145/104, Oxygen Sat 100% 1535: HR 70, BP 150/101, Oxygen Sat 100% 1545: HR 69, BP 153/106, Oxygen sat 100% 1555: HR 73, BP 143/99, Oxygen sat 100% Pt ambulated assisted to the bathroom without difficulty, refusing to go to Emergency room.    Patient was observed for a total of 45min and felt comfortable to go home. Pt was provided with a ride home from friend. Information given including phone number to clinic. Pt stating she is feeling much better.    Patient received the Covid-19 vaccine. She reports symptoms of  I have observed : Patient c/o of feeling light headed and dry throat. Brought to the observation area and VS were as follows: HR 90-95 Pulse ox 100% BP 150/110 C/O feeling warm. States that BP is normally 110-115/70-80's. No difficulty breathing, alert and oriented to person, time, and place.   Repeat Blood pressure 145/104 and heart rate in the 70's.  Oxygen saturation maintained at 100% on room air.    Treatment/intervention Pt was monitored, VS taken approximately every 10 min. Pt given water and juice.  1515: HR 91, BP 150/110, Oxygen Sat: 100% 1525: HR 70, BP 145/104, Oxygen Sat 100% 1535: HR 70, BP 150/101, Oxygen Sat 100% 1545: HR 69, BP 153/106, Oxygen sat 100% 1555: HR 73, BP 143/99, Oxygen sat 100% Pt ambulated assisted to the bathroom without difficulty, refusing to go to Emergency room.    Patient was observed for a total of 45min and felt comfortable to go home. Pt was provided with a ride home from friend. Information given including phone number to clinic. Pt stating she is feeling much better.
10 days after receiving my first shot I notices a red area where the shot was administered.  The site is about 3" wide and 5" long.  It is warm to the touch and is firmer that the areas not affected.  It itches a little but has not caused and other symptoms or problems.  I started to rub the area and it seems to grow bigger like there is a pocket of liquid just under the skin.
Tired, fever, sweaty, anorexia, diarrhea, crying, rash. Monitored closely, gave Tylenol and Motrin. She started feeling better in 5 days. Back to normal in 10 days.
Headache, Sedation, Myalgia, Fever, UrticariaPruritis, NauseaVomiting, chills and fatigue. pain, redness, and swelling at the injection site. Narrative:  Other Relevant History:
Expired vaccine administered to 10 patients (Patient 9 out of 10). No adverse events reported at all; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 9 out of 10). No adverse events reported at all) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 9 out of 10). No adverse events reported at all). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 9 out of 10). No adverse events reported at all) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 24-Jan-2022, the vial was moved from freezer to refrigerator. It was reported that the vaccine was stored refrigerated at the time of the excursion in normal refrigerated temperature range 38 F to 40 F. The pertinent details for the vial were that they it was unpunctured and had no previous excursion. Number of vials or doses impacted 1 vial 7.5 ml (14 dose each).  No abnormality was reported during visual inspection of vaccine state change. There was no product complaint associated. The vial location was in a nursing home and was not sure if they discarded the vial or still had it in the refrigerator.  No treatment medications were reported.
Case number PHHY2011US43957 is a spontaneous report received from a nurse initially on 19 May 2011 with a follow-up on 01 Jun 2011 and 07 Jun 2011. This report refers to a 17-year-old male patient. He was given only the CYW-135 liquid component MENVEO (batch number 091201, expiry date: Sep 2012) intramuscularly at right deltoid on 10 Mar 2011. The patient did not experienced any adverse event. Follow-up report received on 01 Jun 2011. Updated vaccination status. Follow-up report received on 07 Jun 2011. Updated site of vaccination and patient demographics.
Patient received FLUZONE HD on 12/1/14 and is still complaining of a sore arm to this date where vaccine administered.
5x5 cm red, swollen, warm to touch, and painful area at left deltoid area.
Day after the vaccine, I had an itchy, splotchy rash on my neck and back of ears.  It lasted about 5 days.  I also have a very normal and consisitant menstrual cycle, but month I received the shot, my cyce started 5 days early.
Patient came in with red area at injection site of right deltoid. Area warm to touch. Small amount of red streaking to arm. Physician instructed that patient apply warm compress to area.
no adverse side effects have been reported from the patient; improperly stored dose of MMR-II was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 31-AUG-2022, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), subcutaneous injection, 0.5 milliliter, lot #U022985, expiration date: 22-JUL-2023, administered subcutaneously for prophylaxis (strength was not provided) (Product storage error).  Administered dose of vaccine experienced the temperature excursion of -12.3 degrees Celsius for 1 hour. There was no previous temperature excursion.  There was no adverse event reported (No adverse event).
jerking & twitching; pt taken to ER immed; MD felt pt had myoclonic jerks; p/shot pt would wake up frequently & regularly; also slow in development-didn't crawl until 1st birthday, didn't walk until 14months, verbal devel slow;
pt recv vax 11JUL95 & 25MAR97 pt devel rash, h/a, fever & 50-60 lesions some of which are blistered & other that resemble mosquito bites;
Increased "racing" heartbeats,  shaky, tightening in neck/chest, wheezy and coughing repeatedly. She was taken to ED for evaluation. Pt received BENADRYL and epinephrine in ED.
Moderna COVID- 19 Vaccine EUA- Patient reported having a headache and tingling in all fingers that started 15 minutes after getting his vaccine. Patient was given 4.5 mg of Benadryl PO . Patient's symptoms resolved within 5 minutes of taking the Benadryl.
Redness, muscle pain from deltoid to elbow (R) arm, starting 2am following day until today's visit 2-3-12. Treatment - directed to take BENADRYL & ice area, prednisone 10mg as directed x 3 days.
The same day my arm had soreness. On 24March2021 7-730PM I was on computer and typing and I couldn't find the right key and took minutes to type. I had dizziness. My wife took me to ER. Had TIA and bloodwork was normal. On Friday, I had weakness on right side and went to hospital on Saturday. Admitted to hospital for 3 days on 28Mar and left on 30Mar2021 to rehab until 15April2021.
3/26/10 - Rash where vaccine was injected. Swollen for 2 days. 4/15/10 - Had shingles on left foot, 3 spots. They blistered & still have some discomfort. Had shingles in 1/93. Had to go to Pain Clinic to ease nerve pain. Still go every year for an injection from bone spurs that formed after shingles.
had a metallic taste in my mouth, like I did after the initial two vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: E*6198), in left arm and on 25Mar2021 as dose 2, single (Lot number: EP6955) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing), notes: Other medical history: ITP; "Celiac" (unspecified if ongoing), notes: Other medical history: Celiac; "Known allergies: Gluten (celiac dx)" (unspecified if ongoing), notes: Known allergies: Gluten (celiac dx). Concomitant medication(s) included: NP THYROID; LIOTHYRONINE; LATANOPROST; PROGESTERONE. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet", notes: Known allergies: Percocet; Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro. The following information was reported: DYSGEUSIA (non-serious) with onset 01Oct2022, outcome "not recovered", described as "had a metallic taste in my mouth, like I did after the initial two vaccines". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysgeusia.
redness and soreness in left arm close to where injection was given. itchy and burning sensation this happened 2 or 3 days after the vaccine
COUGH, FEVER, HEADACHE, SORE THROAT, URINARY AND FECAL INCONTINENCE
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were each vaccinated with a dose of improperly stored GARDASIL 9 (lot #L026602, expiration date 19-OCT-2017) (dose and route unknown). The vaccine was exposed to 35.3 degree Fahrenheit for 240 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician.
This spontaneous case was reported by a consumer and describes the occurrence of BLISTER on the Face, Collar bone area, and the opposite arm in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced BLISTER on the Face, Collar bone area, and the opposite arm). At the time of the report, BLISTER on the Face, Collar bone area, and the opposite arm outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
On 3/29/2021, I noticed a red spot on my arm near the injection site, but forgot about it. Today (4/1/2021), I noticed a very large red blotchy area on my right arm - it appeared to have spread from the original red spot. The area is approximately 17cm by 6cm in a parallelogram on my arm. It is mildly itchy and sore but otherwise painless.
In August she was diagnosed with a blood clot on her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (In August she was diagnosed with a blood clot on her leg) 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 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced THROMBOSIS (In August she was diagnosed with a blood clot on her leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (In August she was diagnosed with a blood clot on her leg) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company Comment: This case concerns an unknown age female patient with no relevant medical history, who experienced serious unexpected event of thrombosis. The event occurred approximately 25 days after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable since the event occurred after the second dose and no additional dosing is expected. The benefit-risk relationship of vaccine is not affected by this report.; Sender's Comments: This case concerns an unknown age female patient with no relevant medical history, who experienced serious unexpected event of thrombosis. The event occurred approximately 25 days after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable since the event occurred after the second dose and no additional dosing is expected. The benefit-risk relationship of vaccine is not affected by this report.
Moderately extreme fatigue. After sleeping from 11pm-5am, went back to sleep at 7am and slept until 4pm. Feel weak, lethargic, unable to do normal tasks.  Light headache at base of neck. (abnormal) Moderate pain/soreness in left arm.
Headache, Myalgia, Fever, Lethargy, runny/teary eyes Narrative: