chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; dose administered today was after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered today was after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (4 doses monovalent and 2 doses bivalent). Past adverse reactions to the above products included No adverse event with Spikevax.    On 09-Jun-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered today was after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered today was after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (dose administered today was after the published expiration date).    No concomitant medication was reported.  No treatment information was reported.
Muscle ache in arm, extreme fatigue, dizziness, fainted next day, headache, joint stiffness. Still continues three days later, but getting better.
Pt received regular strength flu shot but it was documented as a high dose vaccine. She got appropriate dose. It was just documented as high dose.
79 y/o F pt presents w/ fatigue and cough, onset 10 days. Pt states she received her first dose of the COVID-19 vaccine on 3/2/2021 and reports experiencing sx of HAs, sore throat, bloody mucus, cough, fatigue, and body aches; pt states sx subsided except for the fatigue and cough. Pt reports having taken zicam and coricidin w/ slight relief but states she stopped taking those 5 days ago. Pt reports taking an antihistamine and doing nasal sprays w/ some relief as well.
pt exp sz approx 5 1/2 hrs p/vax; paramedics were called took BP & temp; mom does not know what the readings were; mom states that eyes rolled, arm & hands got stiff, & it lasted approx 2 mins; mom took to ER-t99, blood test was done; no tx
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Past Breast Cancer" (unspecified if ongoing); "GERD" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 02Dec2022 to 07Dec2022).  No follow-up attempts are possible. No further information is expected.
Took oral typhoid as directed starting 8-30-12, last pill 9-5-12. On 9-12-12 noted pin point rash on neck, arms and legs. No pain, no itching, lasted almost 5 days with concentration of rash that still slightly noted on legs 3 1/2 wk. after starting typhoid pills.
Patient lost consciousness for about 5-10 sec after the administration of FLULAVAL vaccine patient was given some water and stated she was fine after about 30 min.
mom gave pt APAP about 1 hr p/MD visit & noon of the same day pt was fussy & would not take bottle;3PM t103 R & pt was very irritable & cried as though in pain;devel rash, splotchy hive like rash on face;seen by MD 3OCT94 dx rxn to vax
Tachycardia,Nausea and Dizziness No Treatment and 3:30 pm was the onset
Vaccinated with Pfizer vaccines in November and  December  2021.  Symptoms started on 12/28 - nasal congestion, fever x few hours.  Resolution of symptoms within 3 days.
Headache; injection was very painful when injected; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection was very painful when injected), INJECTION SITE PAIN (Soreness at injection site) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection was very painful when injected) and INJECTION SITE PAIN (Soreness at injection site). On 08-Jan-2021, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (injection was very painful when injected) and INJECTION SITE PAIN (Soreness at injection site) was resolving and HEADACHE (Headache) outcome was unknown. On 08 Jan 2021 pain is 20% less than previous day.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took one Advil (Ibuprofen) before an hour of injection did not get any treatment after the vaccine for any of these events.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rashes around area of the shot. Neck has severe rash and small bumps around body. Raised bumps on back; Rashes around area of the shot. Neck has severe rash and small bumps around body. Raised bumps on back; Raised bumps on back; This is a spontaneous report received from contactable Consumer or other non-HCP. The reporter is the patient.  A 11-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Nov2021 10:00 (Batch/Lot number: unknown) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: other medical history: No, known_allergies No. Concomitant medication(s) included: TYLENOL. The following information was reported: VACCINATION SITE RASH (non-serious), RASH (non-serious) all with onset 17Nov2021 17:00, outcome "not recovered" and all described as "Rashes around area of the shot. Neck has severe rash and small bumps around body. Raised bumps on back"; MASS (non-serious) with onset 17Nov2021 17:00, outcome "not recovered", described as "Raised bumps on back". Therapeutic measures were not taken as a result of vaccination site rash, rash, mass.  Additional information: The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had tested with covid 19. No known allergies and other medical history reported for the patient.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
While in the shower a day and a half after receiving the second vaccine, patient experienced shortness of breath and nearly lost consciousness. Body shaking. Fainting almost occurred. Light headedness. Increase in blood pressure. Increased heart rate. Increased body temperature.
Approximately 6 hours post injection, sudden onset of arthralgia, myalgia, headache, and lethargy that lasted approx. 10 days. My MD gave me a homeopathic remedy for 2 weeks.
got the worst flu of my life; Initial information received on 26-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who experienced got the worst flu of my life while receiving vaccine INFLUENZA VACCINE.     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious got the worst flu of my life (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the worst flu of my life).  At time of reporting, the outcome was Unknown for the event got the worst flu of my life.
VACCINE ADMINISTERED AFTER 31 DAY REFRIDGERATED DATE BUT BEFORE BEYOND USE 45 DAY EXCURSION DATE.
Redness & swelling day after shot, then seemed to go away.  Day 6 had nausea , fatigue & headache in the evening. Day 7 woke up with rash and nausea, fatigue  & headaches through out the day
Body aches, headache, chest pressure, dehydration, inflammation on her chest walls, they did a EKG and a chest x-ray lab work , iv, Toradol. Started Saturday, October 2 till present she is still having the chest pressure and the headache and the weakness. She has been down since Saturday and Still down .
Case number PHEH2013US026172 is an initial spontaneous report received from a health care professional on 17 DEC 2013. This report refers to an 02 year old female infant. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2013/2014 (batch number: 1310001, expiry date: 31 MAY 2013) intramuscularly at a dose of 0.5 ml on 19 NOV 2013. No adverse event was reported following this administration error.
knocked her out; sinus issues; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "knocked her out"; SINUS DISORDER (non-serious), outcome "unknown", described as "sinus issues".  Additional Information: It was reported that the patient received the first dose of the vaccine and it knocked her out. She also had sinus issues.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
I have not had a period in 2 months (April and May). Last period was on 3/10
right thigh is red, swollen, warm to touch and "tight". mom giving benadryl and tylenol for comfort
Large 5-7 cm area of localized edema, erythema, induration, and warmth on right lateral deltoid area surrounding site of vaccination 3 days prior.  Also had associated fever of 102 and myalgias.
Patient experienced redness, heat, and pain at injection site. Pharmacist referred her to Urgent Care, where she was diagnosed with Cellulitis. Patient received antibiotic therapy.
headache; sore throat; swollen lymph nodes; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2019, the patient received Shingrix (intramuscular). On 11th September 2019, 1 days after receiving Shingrix, the patient experienced headache, sore throat and lymphadenopathy cervical. On an unknown date, the outcome of the headache, sore throat and lymphadenopathy cervical were unknown.   It was unknown if the reporter considered the headache, sore throat and lymphadenopathy cervical to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. The patient experienced headache, sore throat, and swollen lymph nodes on the neck. The patient was seen by her physician who noted the swelling was unremarkable. The reporter consented to follow up.
Large red itchy and swollen area on the arm where vaccine was administered. Area is about a 3 inch circular area, very hot to touch and raised.
Febrile seizure, hospitalized, outpatient EEG and MRI pending.
Information has been received on 31-AUG-2017 regarding a case in litigation from a lawyer and a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 22-APR-2015, 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. On or about 01-OCT-2015, the patient was treated by a physician for the onset of a severe vesicular rash 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. Additional information has been requested.
Skin rash with itching and blisters on hands and arms, started the day after Moderna Covid vaccine dose 2, and persisted for a month. Exactly the same reaction I get from Cephalosporin antibiotics, which I am allergic to.
Large red bump very warm to the touch; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 19:15 (Lot number: 30155BA) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Severe asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoclopramide, reaction(s): "known allergies: Allergy", notes: known allergies: Metoclopramide. Vaccination history included: Bnt162b2 (Dose Number: 2, Single, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 21Feb2021, when the patient was 57 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 02Feb2021, when the patient was 57 years old, for COVID-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 29Oct2021 14:00, outcome "not recovered", described as "Large red bump very warm to the touch". Therapeutic measures were not taken as a result of urticaria.  Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient had not received any other vaccine in four weeks of vaccination. The event Large red bump very warm to the touch did not resulted in physician visit or emergency room visit. The patient was not diagnosed with Covid-19 prior to vaccination. Since vaccination the patient was not test for Covid-19.  No follow-up attempts are possible. No further information is expected.
Inoculation pain and inflammation Day 3: Low grade fever 99.7 and achiness, resolved in less than 12 hours Day 5: Low grade fever 99.3 and achiness, resolved in 4 hours
Persistent abdominal pain in lower right quadrant, followed by abnormally heavy menstrual bleeding in the next week or two. Patient was bleeding through a tampon and large pad every 30-45 minutes for two weeks and became anemic. A pelvic ultrasound was ordered. No cysts or other abnormality was found. Uterus lining was noted as being very thin. Gynecologist prescribed one type of "birth control" pill which helped slow bleeding a little. Another type of pill was prescribed and was able to stop the bleeding.
Developed extensive swelling from site of injection up into right shoulder, right side of neck with right anterior cervical, post cervical and sight supraclavicular lymphadenopathy. Pt given DepoMedrol 160 mg IM, Prednisone 40mg taper over 4 days, and Lortabs for pain.
Rash followed by severe weight loss, dizziness and after 10 days taken to ER.  Diagnosed with Sudden Onset Type 1 Diabetes.
Information regarding PREVNAR was received from a healthcare professional regarding a 9 month old male patient who experienced pneumococcal meningitis. The patient received the third dose on an unspecified date. The patient was taken to the walk in patient clinic and was lethargic in May 2010. The patient was admitted to the hospital with a diagnosis of pneumooccal meningitis. It is unknown if any treatment was given. Outcome was unknown. No additional information was available at the time of this report.
RASH ON LEGS AND ARMS; SORENESS; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 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: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced soreness. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced rash on legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 22-MAR-2021, and fever on MAR-2021, and had not recovered from soreness, tiredness, and rash on legs and arms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
First day after injection all of these events came at one time:  Muscle soreness in thighs & lower back, headache, stiffness both sides of neck, temperature: 101, exhaustion (much like covid), vomiting, severe chills (first day) , burning  bottom of feet and palms of hands.  Redness and swelling vaccination site.  Day 2:   muscle and joint soreness,  no temperature, no appetite,  continued fatique, vaccination site redness, hard.  Site is currently only reaction left..still quite sore and heated, red , swollen and hard.
pt recv vax & devel sz;head circumference was off the end of the scale;dx of genetic tuberous sclerosis has been made;
Patient reported flu like symptoms the day following vaccination lasting 2 days. Patient self treated with acetaminophen second day following vaccination and experienced relief. Symptoms included headache, aches and pains, fever/chills. These symptoms lasted 2 days as mentioned. Patient also experienced fatigue, which persisted for 3 days following vaccination.
Likely not be related directly to vaccine adverse event other than Fatigue and sleepiness reported 2/22/2021.  Patient missed her clinic appointment and we called in to check in with her.  She had no other symptoms.  She rescheduled her appointment to come in for her clinic visit to Tuesday, 2/23/2021 but did not arrive.  We could not contact her thereafter on Tuesday.  We were able to reach her medical power of attorney on Wednesday morning who with the help of EMS was able to enter her home.  We do not know what other symptoms patient was experiencing.  We also had the major winter storm between 2/11 /2021 and 2/19/2021.  This affected are elderly severely.  Unclear what utility she had or how she managed.  On 2/20/2021 patient had only come in for her Covid vaccine appeared tired on that day but most of was struggling through the winter storm and not recovered yet.  Patient was found deceased by her friend and officer who assisted her to enter patient's house.  Unknown time or circumstances of patient demise.
6/4-generalized body aches, headache, ringing in ears 6/5- at injection site, firm & hot to touch, painful, edema & erythema
Inflammation under arm; This is a spontaneous report from a contactable consumer. A 57-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the right arm on 15Mar2021 at13:30 hrs, as a single dose for COVID-19 immunisation. The patients medical history and concomitant medication were not reported. Patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the left arm on 22Feb2021 at13:30 hrs, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 16Mar2021, the patient had experienced inflammation in under arms. No therapeutic measures were taken against adverse event. The clinical outcomes of under arm inflammation was not recovered.  No follow-up attempts are needed. No further information is expected.
On two recent instances of giving Hepatitis B vaccine to neonates (by two different RNs), noted to have leakage from needle connection, not from the leurlock connections between syringe and needle (which is connected by the nurse), but from the factory connection between the needle and the needle protection device). This resulted in the administration of a partial dose.
pt recvd vax;exp cellulitis; devel inject site rxn consisting of swelling, erythema, hot to touch;
Small local reaction with erythema and localized tenderness less than palm of hand one hour after injection. There is increased warmth, no systemic symptoms. Pt is very dermatographic. No history of egg allergy.
Flu-like symptoms, pain at injection site and overall achiness, headache, tiredness, nausea, shivering