chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Quardacel was given to a patient Subcutaneously/no AE; Initial information received on 28-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation.  On 28-Aug-2019, the patient received a single 0.5 ml dose (5th dose series) of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5656AA via subcutaneous route in the right arm.  It was a case of potential medication error due to Inappropriate route of vaccination.  It was reported that no adverse event was experienced by the patient.  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.
eye infection; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (eye infection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. P32L2DA and P32L2DA) for COVID-19 vaccination.     The patient's past medical history included Eye infection (Not lasted more than two weeks) and Cancer (cancer treatment). Concomitant products included FLUOCINOLONE ACETONIDE, HYDROQUINONE, TRETINOIN (ADVAN THF), BUPROPION HYDROCHLORIDE (WELLBUTRIN), TOPIRAMATE (TOPAMAX) and FULVESTRANT (FASLODEX) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE INFECTION (eye infection). The patient was treated with TOBRAMYCIN ongoing since an unknown date at a dose of UNK dosage form. On 13-Mar-2021, EYE INFECTION (eye infection) had resolved. Not Provided          Patient reported eye infection in between first & second  vaccine and lasted a quite a while. She never had eye infection that lasted more than two weeks. Eye infection resolved on 13th March and lasted a good two weeks. Infection started a month ago, treated itself for 2 weeks and then received antibiotics. Infection was quite severe.  Treatment provided also include Rizoicyn for unknown indication. Action taken with mRNA-123 is not applicable.
Patient woke up day after, thigh at injection site red swollen warm to touch and blances. Gave 12.5mg IM Benadryl
Narrative: Patient reported numbness following administration of Pfizer covid vaccine. Patient reported this occurred after first dose as well. Patient was released without any intervention.
Information has been received from a registered nurse concerning a 6 month old female patient. The patient's concomitant therapy, concurrent condition, historical condition and drug reaction were not provided. On 17-OCT-2016 the patient received her first dose of LIQUID PEDVAXHIB(strength, dose and route unknown, lot# M025193, expiration date 21-MAY-2019) at age 2 months, then received her second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB)(strength, dose and route unknown, lot#M027883, expiration date 15-APR-2019) on 19-DEC-2016 for prophylaxis. On 23-FEB-2017, at age 6 months, the patient then inadvertently received a third dose of LIQUID PEDVAXHIB (strength, dose and route unknown, lot # M036612, expiration date 19-MAY-2019) for prophylaxis (inappropriate schedule of vaccine administered). No adverse effects reported. Additional information has been requested.
Patient was vaccinated on 01/08/2009 with Zostavax (LOT 1553X) in the right tricep.  On 01/14/09, the patient received a follow-up phone call and report minor soreness and redness at the injection site.  On 01/16/09 in the afternoon, the patient reported that she had some soreness and tenderness to touch on the left thigh and flank.  On the morning of 01/20/2009, the patient noticed the appearance of a red spot on her left side.  By evening, there were more spots.  The patient did not have a fever.  On 01/21/2009, the patient saw her physician, was diagnosed with shingles, and received Acyclovir 800 mg 5 times daily for 7 days.  She began taking this medication on 01/21/2009.
Patient stated that her tongue was swelling and the she felt dizzy. Throat was itchy then progressed to swelling and chest tightness.  Gave her 50mg of Benadryl and kept monitoring patient. After sometime of no change, she requested the EpiPen. I called 911 and injected one dose of the EpiPen.   Paramedics took patient to Hospital
Head cold; Stuffy nose; Sneezing; Runny nose; Sinus congestion; Occasional cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Head cold), NASAL CONGESTION (Stuffy nose), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and SINUS CONGESTION (Sinus congestion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Head cold), NASAL CONGESTION (Stuffy nose), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), SINUS CONGESTION (Sinus congestion) and COUGH (Occasional cough). At the time of the report, NASOPHARYNGITIS (Head cold), NASAL CONGESTION (Stuffy nose), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), SINUS CONGESTION (Sinus congestion) and COUGH (Occasional cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported  No treatment medication were reported.
Roughly 12 hours after receiving 2nd vaccine I had body aches from head to toe and joint pain Hands knees, wrists, knuckles. Water running over my hands to wash them hurt. First noticed sx walking down the stairs the morning after the vaccine which progressed to muscle aches all over but with intermittent muscle cramping all day into the evening not relieved with ibuprofen or Tylenol. Slight headache but more body aches and muscle cramps. Some nausea, loss of appetite and fatigue. Sx mostly gone in 42 hours. Still having some back pain
Pt. presented 24hrs post immunization with an approx. 6cm in diameter red, blotchy urtsicarial region surrounding area of admin. in L thigh. Raisedm warm and itchy. No systemic reaction noted.
Product Complaint; Red; Raised; Hot to touch; Painful; This case was reported by a pharmacist via call center representative and described the occurrence of skin warm in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number K9L3M, expiry date 29th October 2021) for prophylaxis.   On 2nd August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd August 2019, less than a day after receiving Shingrix, the patient experienced skin warm and pain in arm. On 6th August 2019, the patient experienced injection site erythema and injection site swelling. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the skin warm, pain in arm, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the skin warm, pain in arm, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid. On the same day of vaccination, the patient's arm felt hot to touch and painful starting.  On 6th August 2019, the injection site became red and raised. It was not in a complete circle. All of which were not resolved. The reporter consented to follow up.
The day after patient received  vaccination, she experienced severe and unusual vaginal bleeding that lasted one month. Bleeding contained clots, which is not typical of her menstrual cycle.
This spontaneous report was received from a nurse refers to a 12 year old male patient. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant medication were not provided. Nurse reported that the patient received a dose of GARDASIL on 20-AUG-2015 and he received a dose of GARDASIL 9 on 17-OCT-2015. Nurse stated that the patient came to the practice on 17-FEB-2016 to received his third dose of human papillomavirus (HPV) vaccine, but the practice only had GARDASIL in stock. She didn't specified whether or not the patient will receive a dose of GARDASIL as third dose in his HPV vaccination series. The patient did not reported or exhibited any adverse effects. Additional information has been requested.
I was having a bad sore throat and pain in my ears. I went into my doctor because this was over the weekend. They did a strep test and tested me for Mono. The strep has come back as negative but I am still waiting on the Mono test. I have started having postnasal drip and a cough. Overall I am just feeling tired and not well. I had done an COVID-19 home test and it was negative as well.
Intermittent numbness in both arms and hands began about 3 months after 2nd dose
Moderna COVID- 19 Vaccine EUA: during clinic encounter for follow-up four days later patient reports "near anaphylactic" reaction to vaccine. Within fiften minutes of administration patient began to experience lip and mouth swelling and throat tingling. Patient took diphenhydramine and symptoms gradually resolved. Did not use Epi-pen. During clinic visit patient reports improving swelling and warmth of left arm. No signs or symptoms consistent with infection.
pain,swelling,warmth.and loss of motion worst jan.14,2021 of left arm and warmth to left lymph nodes. Saw Dr Jan 15, 201   done Jan 15, 2021
Fever 103.2 oral temp., vomiting, extreme body aches, breathing issues, coughing
Within one week post vax, pt developed pain in her right elbow, shoulder and wrist. At the time of the report, pain of her both wrists persisted.
p/vax pt was sleeping apnea monitor alarmed for low heart rate; mom removed covers pt shaking, mom picked up pt; pt went limp & had circumoral cyanosis; pt taken to ER
18 hours after receiving the vaccine, I suddenly started having an extreme aura (that preceded a migraine), accompanied by very high blood pressure. (187 over 136....later reaching 200 while in ambulance). I have never had a migraine or aura before. I had only very rarely had  an occasional slight headache in my lifetime. The aura included large blind spots, very blurry vision, and bright white twinkling lights around my peripheral vision, including jagged white lines/lights. I was also lightheaded and dizzy. I was taken from work by ambulance. At the hospital, I was given scans. A small nodule was found on the isthmus of my thyroid, but they said it did not look serious. I was released 3 hours later, which was the time my headache started. Shortly thereafter, I had a migraine and had to lie in the dark with no sound, ice on head. The day after this, almost 48 hours after the vaccine, I noticed that my throat felt thick, and like it was slightly closing. This lasted for weeks. In addition, all the glands around my neck and back of neck felt very swollen, making it hard to swallow. My thyroid tests came back within normal range, but the pain and heaviness continued for about 6 weeks until the endocrinologist put me on prednisone. My headaches have continued since September 25th, pretty much daily. I am trying to take various meds to deal with the pain. I did have an MRI which showed chronic small vessel ischemic disease from high blood pressure. This has been the worst two months of my life. I am meeting with an neurologist this Tuesday morning.
w/in 5 mins after adminstration leg swelled (+) wheal approximately 6 cm in diameter (+) red (+) firm nodule under skin - .2 ml Benadryl 50/1 given IM; Patient monitor in office 1 hour
Her upper lip is a little swollen; Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 31Jan2021 at 08:43 (at the age of 47-years-old) at single dose for COVID-19 vaccination. Medical history included seafood allergy (also happens when she gets seafood from, company name, it makes her lips puffy). Concomitant medications were not reported. The patient stated everything was fine except for some injection site soreness on 31Jan2021 that lasted about two hours then completely resolved. On 01Feb2021, the patient stated this morning her upper lip is a little swollen (puffy). The puffiness as if a 2 year were to head butt you and it left your lip puffy. The patient stated last night for dinner she ate ham which was a different brand than usual and was wondering if it may have had some preservatives in it that could have caused the lip swelling and did not have any lip swelling before she went to bed at 10 pm last night. The outcome of the event lip swelling was unknown. The outcome of the event injection site soreness was recovered on 31Jan2021 after 2 hours.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Weakness and numbness in legs, loss of use of legs , transverse myelitis ,loss of bowel control, urinary incontinence , numerous pulmonary embolisms, dvt?s,  numbness in hands and arms, spinal cord inflammation,  Vision issues  Ivig no help. Steroids - temporary relief but no help. ,
Swollen and very red arm, Fever of 101,  Nausea, Massive migraine headache for 36 hrs,  broke out in rash and giant hives on side and thigh about 48 hours after shot.
upon entering observation area post vaccination, patient informed EMT that she "felt weak, all energy  drained out Of her". this writer notified and went to see patient who reported same symptoms. States  she has an Epi Pen for allergies to all fragrances. At 3:25 BP obtained from EMT, 202/112 HR 80, Patient  states on Atenolol 5Omg OD, confirms she did take her medication today. patient's husband States that  her face looks flushed to him. Talked to patient about transferring ta ED for evaluation. BP redone at  3:33 204/112 HR 84, EMT called 911 for transportation to ED, Arrived at 3:44pm, to transfer patient to  hospital. Husband to follow. Additional information for Item 18: Encouraged patient to follow up with PCP to Inform them of situation and obtaining second vaccination. 3/3/21 called patient today  to see how she was feeling, States Is feeling better, worn out, when this has happened in the past it takes a few days to recover. States ED physician told her it was due  to the vaccine and to follow up with her PCP. She states she has an appointment for Monday, 3/8/21.
There is no adverse reaction to report. The pt was given Bexsero as their first meningococcal vaccine ever instead of MCV4 and he is under the recommended age of 16 for Bexsero
Rash developed on her hand and feet 2days ago; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash developed on her hand and feet 2days ago) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced RASH (Rash developed on her hand and feet 2days ago). At the time of the report, RASH (Rash developed on her hand and feet 2days ago) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.  The patient took the Benadryl and hydrocortisone cream on 17-Sep-2021 as treatment.
FEVER 100.9F; This spontaneous report received from a patient concerned a male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, heart murmur (since child birth), no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced fever 100.9f. Laboratory data included: Body temperature (NR: not provided) 100.9 F, 98.4 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 100.9f on 13-MAR-2021. This report was non-serious.
This spontaneous report was received from the Vaccine Coordinator referring to a 14 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 26-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX with one of these lot #'s reported  M017292, expiration date on 07-APR-2018; lot # N017701, expiration date on 09-JUN-2019 or with lot # N019127, expiration date on 22-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 7.52 F degrees Fahrenheit for 24 hour, and had a previous temperature excursion of 5.5 F degrees Fahrenheit for 1 hour. There was a digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008693.
ENTIRE UPPER LEFT DELTOID SO SORE, COULDNT OT LIE ON DURING SLEEP THAT NIGHT. SHOWERING NOTICED ENTIRE UPPER ARM EDEMATOUS & 2 AREAS OF ERYTHEMA HORIZONTAL SEVERAL CM X CM GOING DOWN TO MY LEFT AXILLARY, ENTIRE LEFT UPPER ARM TENDER TO TOUCH & WARM. I HAVE HAD THIS IN 1994-95 & REMEMBER MY ENTIRE AXILLARY WAS SO SORE, I COULDN'T HOLD MY PURSE, BUT NOT THIS MUCH EDEMA/ERYTHEMA. I AM A FAMILY NURSE PRACTITIONER & HAVE GIVEN THOUSANDS OF ALL VACCINES, HAVE NEVER SEEN THIS. ALSO, THE NIGHT OF THE VACCINE, I GOT A SORE THROAT, WHICH I STILL HAVE, STARTED COUGHING YESTERDAY, 1/26, STILL COUGHING, & NOW FEEL COLD & HAVE A TEMPERATURE OF 100.4. I HAD ANOTHER ICU RN LOOK @ MY ARM & SHE CONCURRED TO REPORT. WE HAVE HAD 7 PEOPLE INCLUDING CHILDREN DIE DUE TO INFLUENZA A DESPITE BEING IMMUNIZED. I GOT MY FLU SHOT IN AUGUST 2014 & MY HUSBAND THE SAME DAY & HE ALSO GOT THE SAME Pneumovax 23 vaccine the same day/time & he is fine & he is severly allergic to the Td & has asthma, eczema, etc., triad.
pt vaccinated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HAV (Havrix) (batch number HA9Y9, expiry date 17th June 2022) for prophylaxis.   On 21st June 2022, the patient received Havrix. On 21st June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The reporter stated that that the patient was vaccinated with an expired dose of Havrix.  The reporter gave consent to follow up. Additional supportive Information: The patient was vaccinated with an expired dose of Havrix which, led to expired vaccine used.
I received a flu shot at pharmacy in upper left arm 9/13.  Intense aching pain and severly limited range of motion began the next morning and lasted for two days.  Pain then lessened a bit and range of motion increased a bit, but both still continuetwo weeks laterto be very strong problems that limit my daily behavior.  Sleep disruption due to pain is constant.  Many aspects of my life are affected because of the inability to use my arm completely and because of the pain. I was afraid of shoulder damage, so I visited an orthopedist 9/24.  X-rays of shoulder ruled out impingement or other causes.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient experienced no adverse events.   This case was linked to MOD-2021-395985 (Patient Link).
Extreme shivering 12 hours after vaccine (duration 4 hours); Ache at site of injection; All over body aches; Bad headache; Slight nausea; Woke up morning of 3/23/2018 drenched in sweat, symptoms dissipated after that except for a mild lingering headache the rest of the day. Received vaccine on Thursday afternoon and had to miss work on Friday.
Thru Sept small blisters appeared on face and shoulder, than a few days later on arms, then buttocks and legs. They looked like insect bites but scabbed over, exactly like my other child's case of chickenpox.
Headache, Sedation & Myalgia Narrative:  'down for 12 hours"  Other Relevant History:
INFLAMMATION; SEVERE EAR RINGING (TINNITUS); This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On JUN-2021, the patient experienced inflammation. On JUN-2021, the patient experienced severe ear ringing (tinnitus). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe ear ringing (tinnitus), and inflammation. This report was non-serious.