chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 15-JAN-2019, the patient received an improperly stored dose of PROQUAD (Lot # R012416 and expiration date 28-OCT-2019), subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of PROQUAD was exposed to a temperature excursion of 11.9 Fahrenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1903USA002598: US-009507513-1903USA002599: US-009507513-1903USA002597: US-009507513-1903USA002596: US-009507513-1903USA002595: US-009507513-1903USA002600.
Woke up not feeling good. Had body aches and took tylenol and vision started to become blurry.
lost consciousness after receiving vaccine, was sitting down, regained consciousness after about 5 seconds. Patient was pale but recovered color after several minutes.
achiness; vertigo for 2 weeks; was not able to get out of bed due to fever (101F); general malaise; joint swelling in joints and fingers; pain in abdomen; severe vertigo; Initial information regarding an unsolicited valid non-serious case received from other healthcare professional via Agency (Reference number- 00521425) and transmitted to Sanofi on 16-Mar-2021.  This case involves a female patient of unknown age who experienced joint swelling in joints and fingers (joint swelling), pain in abdomen (abdominal pain), severe vertigo (vertigo- first episode), was not able to get out of bed due to fever (101f- Fahrenheit) (pyrexia), achiness (pain), general malaise (malaise) and vertigo for 2 weeks (vertigo- second episode), after she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  Past vaccination(s) included Fluzone and Adacel in 2013 (Fluzone Trivalent and Adacel vaccine in 2013, the patient experienced severe vertigo, joint swelling in joints and fingers, and pain in abdomen in 2013 and this was called in and reported in 2013).  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medications were not provided.  On an unknown date, the patient received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On an unknown date, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown site of administration for prophylactic vaccination.  On 16-Mar-2021, patient who experienced joint swelling in joints and fingers (joint swelling), pain in abdomen (abdominal pain) and severe vertigo (vertigo- first episode), (latency: unknown) following the administration of suspect vaccine.  On an unknown date, patient who was not able to get out of bed due to fever (101f) (pyrexia), achiness (pain), general malaise (malaise) and vertigo for 2 weeks (vertigo-  second episode), (latency: unknown) following the administration of suspect vaccine.  She was scheduled for a Moderna COVID (coronavirus disease) vaccine on 19-Mar-2021 and she wants to know if the Fluzone Trivalent vaccine match up with the Moderna Corona vaccine ingredients.  It was not reported if the patient received a corrective treatment.  Outcome of the events was unknown, at the time of reporting.  There will be no information available regarding batch number in this case.
Increased tenderness and pain to uppper arm/shoulder. Arm feels heavy at times. Limited mobility of arm due to pain.
This spontaneous report as received from a physician via field representative refers to a 18 year old male patient. On an unknown date the patient was vaccinated with the third dose in the series of GARDASIL (route, dose and lot # not reported). One week later the patient presented with genital warts. The reporting physician referred the patient to a dermatologist. Treatment was given. The patient was evaluated by the physician. Outcome of the event was not reported. Additional information has been requested.
runny nose; sore throat; cough; fever; headache; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for (at the age 69-year-old) COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, it was unknown if the patient was tested for COVID-19 or not. It was unknown if the patient received any other vaccine within 4 weeks prior to the COVID-19 vaccine. It was unknown if the patient had any allergies. The patient's medical history and concomitant medications were not reported. On an unspecified date, after first dose, the patient experienced runny nose, sore throat, cough, fever and headache. Patient was following up with personal doctor for additional testing. The adverse event resulted in doctor or other health care professional office or clinic visit. It was unknown if the patient received any treatment for the events. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2, was not provided and would be requested during follow up.
Information has been received from a medical assistant concerning a 2 month old female infant who on 29-JUL-2008 was vaccinated orally with a first 2ml dose of ROTATEQ.  Concomitant therapy on that same day included TYLENOL.  It was reported that infant spit all of the vaccine out of her mouth.  It was noted that the infant was given TYLENOL prior to the vaccination.  It was also noted that the infant probably did not like the taste of the vaccine.  Medical attention was sought at the office.  At the time of the report, the patient's status was unknown.  There was no product quality complaint involved.   Follow-up information has been received from a medical assistant concerning a 41 month old female patient (previously reported as 2 month old) who on 29-JUL-2008 was vaccinated with a first dose of ROTATEQ.  There was no illness at the time of vaccination.  It was reported that the patient spit out the majority of the vaccine.  At the time of the report, the patient's status was unknown.  Additional information is not expected.
Right thigh swelling and redness noted at inject site. Able to move leg w/out difficulty.
Started with tongue going numb/slight swelling, followed by face becoming numb, numbing in arms to numbing to legs.  She was almost home when she started noticing her tongue going numb.  She had Covid 19 in October 2020 and experienced face numbing and numbness in hands that would come and go.   She does not really go to the doctor often.  Her MD has retired.
Approximately 5 hours after receiving vaccine patient in to anaphylactic shock and was taken to the E.R.
Swelling redness of entire left upper arm, warm to touch (-) Fluctance (+) ROM occurred within 24 hours of vaccination. Tx: compresses + Advil. Seen in office 8/23. F/U arranged for 8/26.
Incident in December was a really bad cough and nasal congestion. I did go to the doctor for this instance, but I had a PCR test during this time and it was negative as well. January 10, I had a telehealth visit for the same symptoms. March 31, telehealth. April 22, urgent care. COVID, it started with a sore throat. Then moved into a headache and body aches. I had a slight fever at around 99 degrees for two days. I had those symptoms and then I had some congestion. I had some nasal drip and a cough. Those symptoms lasted for probably through April 2nd, 2022. The biggest symptom was fatigue. I was fatigued, but just with a slight cough for the whole next week through April 8th. I was pretty good for a week, and I don't know if it's related, but on April 20th in the evening, all I wanted to do was sleep and I was totally congested, worse than before. Worse than when I had initial COVID. From the 20th-23rd, all I wanted to do was sleep and had the congestion. Didn't have the cough as much but had the post-nasal drip. That lasted until about the 30th of April. Still had the nasal drip and fatigue, but I'm still not up to my old energy. I did also get the stomach flu at 1:30 in the morning May 9th with vomiting and diarrhea and that only lasted for 2 hours. Then just fatigue. Not sure if that's related. I've never been a napper, but all I want to do now is take naps.
Difficulties breathing within 5 minutes of getting the vaccine, Lightheaded, fast heartbeat, pain on the arm of injection. Within 1 hour: headache, tiredness, swelling on the site of the injection.
Moderna COVID-19 Vaccine EUA: patient presented to emergency department with weakness, nausea, myalgia, and fever, tachypneic and tachycardic one day after immunization in setting of poor oral intake.  Hospitalized, administered IV fluids and antibiotics, and discharged home one day later medically stable and back to baseline.
I felt somewhat tired and weak.  I had a headache that lasted several hours.  I had muscle pain, mostly in my chest.  I had chills that lasted for several hours, but not as long as the headache.  Most of these symptoms lasted around 10 - 12 hours.
Small dry patch; Rash (red, raised, hot); felt like my lymph nodes were inflamed; Armpit tenderness; My arm was sore; Brain fog; A spontaneous report was received from a healthcare professional, a 39 year-old female patient, who received Moderna's COVID-19 Vaccine and experienced arm was sore, brain fog, armpit tenderness, felt like lymph nodes were inflamed, rash (red, raised, hot), and small dry patch.  The patient's medical history was not provided. Concomitant product use was not provided.  On 23 Dec 2020, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly in the right deltoid for COVID-19 infection prophylaxis.   The patient stated that her arm was sore for and that it was not like any other soreness she had after receiving other shots. She reported that 3 hours after the shot she had brain fog.  On 29 Dec 2020, the patient experienced armpit tenderness in the same arm she received the shot that lasted a week or more. She reported that it felt like her lymph nodes were inflamed. The patient stated she had an ultrasound and it was okay.  On 04 Jan 2021, the patient developed a rash that was raised, red and hot. She stated that it was better but she still had a small, dry patch. Treatment for the events included triamcinolone.  Traimcinolone included as treatment drug.  Action taken with mRNA-1273 in response to the events was unknown.   The brain fog, was considered resolved on 23 Dec 2020. The arm was sore, was considered resolved on 28 Dec 2020. The armpit tenderness and felt like my lymph nodes were inflamed, were considered resolved on an unknown date.  The rash was considered resolving. The small dry patch, was considered not resolved.; Reporter'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.
Tinnitus, ongoing and no cure. Saw ear doctor on May 13. Will be going back as issue has not gone away. Was not aware this could be a Covid vaccine side effect so did not initially report.
sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B2A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Post-traumatic stress disorder.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Mar-2021, VACCINATION SITE PAIN (sore arm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a Medical assistant referring to multiple unknown patients of unknown age and gender. Patient's concurrent conditions and medical history were not reported. On an unspecific date the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M010212, expiry date 21-JAN-2019) concentration, dose and route of administration were not reported. Concentration, dose and route of administration were not reported. It was reported that the temperature excursion was for 46 minutes at 1.7 degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
After about 2 hours, felt like in a fog ... then at about 6 hours started feeling joint stiffness,  achy in upper back, shoulders areas, of course soreness at injection site but not severe.  No at about 20 hours post-vaccine, achy in upper back, shoulders areas worsened, but still not severe, soreness at injection site the same.
Shakings of extremities witnessed by parents about 24 hours after 2nd dose of PENTACEL, PREVNAR, ROTATEQ. Episodes lasted about 1/2-1 min and occurs in clusters of 4-5.
no adverse event; a 14 month old old was given PROQUAD and VARlVAX together yesterday on 12/28/20; This spontaneous was received from a medical assistant, concerning a 14 month old patient of unknown gender. No information was reported regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies.  On 28-DEC-2020 (reported as yesterday), the patient was given measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) together for prophylaxis (strength, dose, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported) (duplicate therapy error). No further adverse event was reported.
Narrative:  No documentation located in chart regarding ADE of urticaria to tetanus toxoid as vaccine was given outside clinic.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-FEB-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml/five dose vial, lot # K007773 and expiration date 01-MAY-2015 (administration route was not provided). No adverse effects were reported. The vaccine had four temperature excursions one of 24 hours with a lowest recorded temperature of -1 Fahrenheit (F) (-1 Celsius (C)), the other one of 48 hours with a lowest recorded temperature of 1 F (1 C), the third one of 72 hours with a highest recorded temperature of 9 F (9 C), and the last one of 48 hours with a lowest recorded temperature of 0 F (0 C). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Onset of severe abdominal cramps on 04/16/2021, two days after the vaccine. Cramps lasted approx. three days. States she was bedridden with them. States she took Ibuprofen and used warm compresses. Issue resolved.
5 minutes after getting VARIVAX pt started sneezing, progressed to cough, chest pain, palpitation, on exam urticaria on eyelids, face swelling & swelling of nares R.  8/8/08 Reviewed PCP medical records which included vax record.  Within 5 min of receiving 2nd varivax, began sneezing.  On way home, sneezing increased, cough, chest pain, difficulty breathing, palpitations developed & returned to office.  On exam, had urticaria of eyelids, nasal congestion, increased HR, pulse ox 97% on RA, lungs clear.  Tx w/antihistamine.  Developed swelling of nasal mucosa.  Tx w/epi & transported to ER where received oral steroids, condition remained stable & d/c to home w/epi-pen.  Referred to allergist & seen 7/16/08.  Skin prick testing (+) for grass & weeds.  RAST test was recommended.
ordered FLUZONE QUADRIVALENT but was sent FLUZONE HD instead with no reported adverse event; The FLUZONE HD was administered accidently instead of FLUZONE QUADRIVALENT with no adverse event; 13 years old patient recived FLUZONE HD with no reported adverse event; Initial information was received on 09-Nov-2021 regarding an unsolicited valid non-serious case received from a Physician via the Agency (under reference number - 00849976).  This case is linked to cases 2021SA376763(CLUSTER) and 2021SA378956(CLUSTER).  This case involves a 13-year-old female patient who was accidentally vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] due to ordered FLUZONE QUADRIVALENT but was sent FLUZONE HD instead with no adverse event (product dispensing error) (wrong product administered) (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 28-Oct-2021, the patient received a 0.7ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number UJ773AC and expiry date was not reported) via intramuscular route in the left arm for prophylactic vaccination.  There were no laboratory data/results available.  It was case of an actual medication error due to drug dispensing error, wrong vaccine administered and inappropriate age at vaccine administration (latency was on same day)  At the time of report, no adverse events were reported.  Event outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
That Wednesday I had pain in my back. I thought it was a rib out and then I started feeling a tenderness below my right rib when I would press it and then 2 days later I had a rash and on Sunday morning I noticed a break out at 10:30am. At noon took Valtrex for 8 days. I think it really helped a lot I am still going through the symptoms almost 28 days later I also have tightness in the center below my diaphragm like an ulcer. On Wednesday I also had a telepath appointment for internal pain. In 2014 I had the old Shingles vaccination.
asplenic pt w/a prior hx of Hodgkins disease was revaxed; 1st immun in approx 6 yrs; w/in 24 hrs, exp an inject site react hwich included erythema (2" in diameter), inudration & pain; also had chills & fever; no treatment ititiated;
After the vaccines, a year ago, she suffered a stroke; 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), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 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: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "After the vaccines, a year ago, she suffered a stroke".  Clinical course: It was reported that patient was in her early 80's and stated that feeling weary of getting the booster and asked if there were any double blinded studies of people around her age having strokes related to the Pfizer Biontech COVID-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
second vaccine: Severe dizziness, nausea, gastro upset  first vaccine: muscle weakness, dizziness, nausea
Patient falsified DOB when registering for vaccination. Guardian consented to the vaccination. Health department verified with records that the patients actual DOB  which made the vaccine a contraindication.  No known adverse reactions noted.
Vaccine administered to age less than 18; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to age less than 18) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to age less than 18). On 30-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to age less than 18) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2021-147956 (E2B Linked Report).
Fever, malaise within one hour of receipt 10 cm diam redness around 2 cm tender, firm center. Initial nausea, somnolence, arm & leg pains.
This case was reported by a other health professional via call center representative and described the occurrence of tremor in a 14-year-old female patient who received HAVRIX pediatric (batch number F3J75, expiry date 18th November 2017). Concurrent medical conditions included stomach virus. On 6th January 2016, the patient received HAVRIX pediatric (intramuscular). On 6th January 2016, 1 hr after receiving HAVRIX pediatric, the patient experienced tremor, diarrhea, stomach pain and nausea. On an unknown date, the outcome of the tremor, diarrhea, stomach pain and nausea were unknown. It was unknown if the reporter considered the tremor, diarrhea, stomach pain and nausea to be related to HAVRIX pediatric. Additional details provided were as follows: The patient received a dose of HAVRIX pediatric vaccine in right deltoid and beginning 1 hour after receiving the vaccine, the patient experienced shakiness, nausea, mild diarrhea, and stomach pain. It was unknown to the healthcare professional if the patient's symptoms were related to the HAVRIX pediatric and were believed to be a stomach virus. Fluids and rest were recommended as treatment and no emergency room or doctor visits was required.
24 hours after vaccine I had slight headache, 36 hours later I had headache and nausean. 40 hours after vaccine I had headache, nausea, fever (100.2) and chills. By 60 hours after vaccine I was feeling normal.