chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    No concomitant medications were provided. No treatment medication was provided. This case contains information for the 3rd adult patient out of 15 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-658139, US-MODERNATX, INC.-MOD-2022-658159, US-MODERNATX, INC.-MOD-2022-658149, US-MODERNATX, INC.-MOD-2022-658161, US-MODERNATX, INC.-MOD-2022-658162, US-MODERNATX, INC.-MOD-2022-658154, US-MODERNATX, INC.-MOD-2022-658160 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658139:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658149:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658161:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658154:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658159:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658162:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658160:Adult patient 3
Fever/ a fever right around a 100 Degrees; Chills; Headache; Body aches; This is a spontaneous report received from a contactable consumer or other non hcp.A 54-years-old female patient received 1st dose of bnt162b2 (Pfizer Covid-19 Vaccine,Batch/Lot Number: EN6204),via an unspecified route of administration on 17Mar2021,at the age of 54 years old, as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced fever, chills,headache, body aches on 17Mar2021.The patient underwent lab tests and procedures which included pyrexia: 100 degrees on Mar2021.Therapeutic measures were taken as a result of fever/ a fever right around a 100 degrees.The patient received tyenol as treatment for fever.The outcome of the event fever was not recovered while other events outcome was recovered.  Follow-up (21Mar2021): This is a spontaneous report received from Pfizer sponsored program Support. A contactable female consumer (patient) reported for herself  that Cold transferred to hospital. Manual  form created.  No follow-up attempts are needed. No further information is expected.
t107;sz >60min, encephalopathy, loss of milestones (used to walk now cannot sit);
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender who on an unknown dates was vaccinated with: the first dose of GARDASIL (dose, route and lot # not reported), the second dose of GARDASIL (dose, route and lot # not reported) and with the third dose of GARDASIL (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. Nurse reported that the patient received the 1st and 2nd doses of GARDASIL 1 year apart, and the patient received the 3rd dose 1 month after the 2nd dose. No adverse effect reported. Additional information has been requested.
The first Moderna shot only caused a very sore arm for three days. It's the second shot that caused adverse problems. I guess I have to fill out a new form for that shot on April 1st?
Bilateral petichial rash and blisters on dorsal aspect of hands between thumb and index finger
Day 8 a hard, red spot approximately 1? in diameter. The area worsened and became very hot and itchy. Day 15 spot is about 6? x 5?
Information has been received from a nurse concerning a 20 year old female who on 04-APR-2008 was vaccinated intramuscularly in the left arm with a 0.5 mL first dose of GARDASIL (lot # 659182/1757U). The nurse reported that by 11-APR-2008 the patient had a rash on both wrists. The nurse also reported that the rash was more prominent on the left wrist. On 14-APR-2008 the patient called the doctor's office and reported that she will follow up with her primary care provider. It was reported that therapy with GARDASIL will be discontinued "pending outcome". Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 18-year-old female patient who received Meningococcal B vaccine for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was not recovered/not resolved. It was unknown if the reporter considered the feeling abnormal to be related to Meningococcal B vaccine. Additional details were provided as follows: The patient's mother reported this case.  The age at vaccination was not reported. The reporter did not know the brand name of Men-B vaccine. The reporter did not specify patient's symptoms. The reporter wanted to know about her daughter having side effects from the vaccine. The reporter states it had been a week and still the patient was not feeling good. The reporter was going to take the patient to emergency room on the day of reporting. No other information obtained from chatter before the chat was closed; contact information obtained because chatter initiated another chat with the agency.
Right arm-injection site large red area. -Hot to the touch-swollen. -Difficulty moving-arm up-mobility-red and beginning to itch on Sunday 10/30/16. PS Also redness from flu-shot in other arm. But small areas-multiple.
Patient stated that she started experiencing numbness and tingling in her left middle finger and ring finger after receiving her vaccine. She was received in the Medication Observation Unit 1 and made comfortable on the stretcher. Patient vital signs were checked and neurological examinations were performed. Patient stated a relief in symptoms after 30 minutes of observation. Vitals sign were stable and patient was released at 1719.  At 1740, patient came back to us and reported tightness in the chest and pain at her back. She was made comfortable in bed but refused for her vital signs to be checked including seeking immediate medical assistance. she insisted that, she is not in any position to visit ER at this time but will rather watch over her symptoms and report to the ER if it persists. She was released at 1745
patient reports feeling symptoms of headache and fever on may 7th and may 8th after getting her 2nd covid-19 vaccine. may 9th she reports feeling better. On May 10th, she reported vertigo.
The pt experienced a local reaction to the DT vaccine. This is one of three pt's to report a local reaction after receiving a similar vaccine in the past two weeks.
feels a little groggy; his right arm is achy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (feels a little groggy) and PAIN IN EXTREMITY (his right arm is achy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Atopic dermatitis.   On 01-Apr-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) UNK, Total. In 2021, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced SOMNOLENCE (feels a little groggy) and PAIN IN EXTREMITY (his right arm is achy). At the time of the report, SOMNOLENCE (feels a little groggy) and PAIN IN EXTREMITY (his right arm is achy) had not resolved.            No relevant concomitant medications were reported. On 01-Apr-2021, the patient started taking DUPIXENT (DUPILUMAB) via pre-filled pen, at unknown loading dose followed by 300 mg every other week (QOW) via subcutaneous route. No treatment medication reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622284.
full blown head/sinus; chills; tiredness; feeling that throat was scratchy; little tired the following day after the 2nd dose.; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 16:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, milk allergy and sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced a little tired the following day after the 2nd dose. On 05Apr2021 at 16:00, the patient experienced feeling that throat was scratchy. On 6Apr2021, experienced full-blown head/sinus cold accompanied by chills and tiredness with no fever. Patient did not receive any treatment for the events. The clinical outcome of the events tiredness, itchy throat, sinusitis, cold, chills was resolving at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (dose was not reported, lot#K009900 with expiration date 04-MAY-2015 or lot # reported ass K025343 with expiration date 22-MAY-2016 or lot # reported as K020181 with expiration date 25-JUN-2016 or lot #L000434 with expiration date 18-JUL-2016). There were no adverse events reported. This is one of several reports received from the same source. Additional information has been requested.
Patient reported that his left arm was red and swollen and painful from the area of the shot down to his elbow. He reported no fever. He was taken naproxen for the pain and inflammation.
Onset fever and vomiting about 36 hours after vaccines followed by seizure activity 48 hours later. Admitted with status epilepticus with complex seizures.
body aches and joint pain behind knees in the first few days and lasted for several days. The recent and most alarming event is the swelling right knee that is noticeable. Will see doctor on Tuesday if symptoms persist
metallic taste; arm soreness; This is a spontaneous report from a contactable other-HCP (patient herself) via Medical Information Team. A 65 (units unknown) old female received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 01Feb2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization and experienced arm soreness with first dose. Patient stated she received both doses of the vaccine, the second dose was on 01Feb2021. She had no side effects with either dose, except for a slight metallic taste on an unspecified date in Feb2021 after the second dose but nothing major. She had nothing with the first injection and nothing with the second. She had arm soreness with the first dose and slight arm soreness with the second dose on an unspecified date in Feb2021. She stated she had nothing, absolutely nothing and it worried her. She also asked if she needed to have antibodies checked to see if there was something with the dose that was not right. She stated she needed to have lab work done anyway. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
28FEB95 yellow fever given; 1MAR 3, 5, & 7 of MAR95 Typhoid taken; 1MAR95 low grade temp 99.8 (o) & diarrhea; 5MAr95 vomiting x 24 hrs & severe msucle aches;
Received vaccine at approximately 11am. At 7pm that same night, employee c/o sweating profusely with uncontrollable chills along with muscle cramps (legs and feet). C/o feeling extremely weak and felt he would pass out. At midnight, he felt a migrating heat from chest to back and down to scrotum. He fell asleep at 2am.
Pt had swelling (+) redness to both legs after pt. received vaccines. Legs were also hot to touch from injection site to bottom of feet. Ice cold compression. BENADRYL and MOTRIN for Tx.
I am experiencing heavy vaginal bleeding (12 days and counting) since the third day after the injection. With the fisrt dose received at a Hospital on April 14th, 2021 I was bleeding for 28 days since the fourth day after the first dose of the COVID vaccine. I developed anemia (10.6), a high count of white blood cells (15,000), chills, low blood pressure, fever, persistent muscle and joint aches and an urinal infection. I had to wait two months to receive the second dose and even then I started to experience the same symptoms 3 days after getting the second shot.
swollen, painful axillary lymph node started approximately 24 hours after injection of COVID vaccine booster
Scratchy throat; Cough; Sinus problems; Felt like upper respiratory infection; Sore arm for a couple of days after both doses; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy throat), COUGH (Cough), SINUS DISORDER (Sinus problems), UPPER RESPIRATORY TRACT INFECTION (Felt like upper respiratory infection) and VACCINATION SITE PAIN (Sore arm for a couple of days after both doses) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included VITAMINS NOS for Blood pressure high.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROAT IRRITATION (Scratchy throat), COUGH (Cough), SINUS DISORDER (Sinus problems), UPPER RESPIRATORY TRACT INFECTION (Felt like upper respiratory infection) and VACCINATION SITE PAIN (Sore arm for a couple of days after both doses). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (Scratchy throat), COUGH (Cough), SINUS DISORDER (Sinus problems), UPPER RESPIRATORY TRACT INFECTION (Felt like upper respiratory infection) and VACCINATION SITE PAIN (Sore arm for a couple of days after both doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medications include daily blood pressure medicine.   This case was linked to MOD-2021-280584 (Patient Link).
nosebleeds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 04Mar2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 10Mar2022, outcome "unknown", described as "nosebleeds".  Additional information: Patient never had nosebleeds before   The lot number for bnt162b2 was not provided and will be requested during follow up.
Had enhanced flu shot in morning. After I went to bed, awoke with bad chills, shivering. Kept up all night. Body aches and deep cough developed. Shaky on my feet, stumbled going to bathroom. Slept most of day 10/15 and again that night. Was fine on 10/16.
pt recvd vax & 1 wk following vax lab eval revealed that pt was surface antigen pos; nurse felt the pt's exp was not due to the vax; No further details were provided;
Felt tired; developed a temp of 100.4-102; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for herself that. A female patient of an unspecified age received bnt162b2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date of Feb2021 the patient experienced felt tired and developed a temp of 100.4-102. The patient underwent lab tests and procedures which included body temperature: 100.4-102 on an unspecified date and sars-cov-2 test on 15Feb2021 and result was negative. The outcome of the events was unknown.   Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
2/5/02 2pm vaccine given. 2/6/02 am - mom noticed red, warm swelling on left upper arm 2x4". Complained of pain. Tylenol given.
Red, hot, itchy, swelling like the size of 2 baseballs together.
Pt stated that 2nd dose was more than 6 months ago, upon review of vaccine record it was actually 5 months ago. No physical reactions were observed or reported.
Pt developed tingling in her fingers and arms starting the evening after vaccination.  Pt also developed tingling in face the wednesday after vaccination.  Encouraged pt to see PCP.
11/01/05 - Received pneumococcal (POV23) vaccine that evening increase soreness, in late evening, flu-like symptoms (queasy, malaise, chills and fever). 11/02/05 - Early AM increase erythema at site and increase swelling "ham hock" arm and painful. 11-03-05 - C/O 48 hours decrease swelling and erythema, started to feel "normal." by evening most symptoms dissipated.
My right temple started to get sore to the touch, I?m about day 3 post injection. It is fine unless I touch it, but if I do bump it or make contact with it, it hurt like the area was very bruised or recently injured.  The pain has improved but it is still very sensitive. I didn?t think it was related to the shot, but I could not recall any injury.  I can  function like normal.  My dr suggested I do a round of steroids, but to contact her immediately or go to ER if it worsened.  I am to follow up with her in 2 weeks.
Hives, 5 hours, post vax, on 2/20/01. Child was in no acute distress and responded to Benadryl IM with resolution of hives, within 1 hour. Pt will be referred to allergist before further IZ's.
I may have the brands off for the vaccines, I'm reading off of his past visit report. He had extreme pain in his legs, couldn't stand or walk for hours. He was screaming from around 9pm until 11:30pm from pain, I could not touch his injection site or hold him anywhere but around his chest without him screaming and shaking. he developed and fever of 105* around, we went to the ER and they said it was normal, it went down after Tylenol, but was back up to 105.6* at 5:30am. At 8:30am he had a fever of 104.4* and we went into his doctor, who found he had developed an ear infection "as a result of the vaccines". He had a low level fever until 8/23/19
From pt directly: "The evening I went to bed after the vaccine, I woke up in the middle of the night in severe arm pain. I slept through most of the next day and had severe arm pain, body aches, and chills. I was feeling a lot of eye pain, and I couldn't open my eyes for more than 20 minutes at a time. I also had a persistent headache for the next few days. I think it is the sickest I have ever been. Those intense symptoms subsided after a day. It did take me 3 days to feel fully back to normal health."
Pt came in the clinic on 5/20. Mom states that on 5/19/09 pt had fever 105 and rash. Today rash is worst but no fever. Red bump raised pink on abdomen, back, chest and extremities.
Localized erythema, induration 5x6 cms, itching. Child given 12.5 mg Benadryl BID x 2-3 days for itching, instructed to apply cold to site.
Onset of fever initially 101.5 and then increased to 104.5 with 4-5 bouts of watery diarrhea with small amounts of blood.
Information has been received from a health professional concerning a 7 year old female who on 29Nov99 was vaccinated with a 0.5ml SC dose of varicella virus vaccine live (lot 628697/1838H). On 09Oct05 the pt presented with about 42 vesicular lesions over her body. It was reported that the child has since fully recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that there was no additional information to be reported on the pt. Additional information is not expected.
No additional AE/PQC; Caller reported AE on behalf of a patient who received a vaccination of PROQUAD with expired STERILE DILUENT (no prior TEs). No symptoms reported. Obtained consent to contact HCP. AE Filed (Case #02463498). No additional AE/PQC.; Caller reported AE on behalf of a patient who received a vaccination of PROQUAD with expired STERILE DILUENT (no prior TEs). No symptoms reported. Obtained consent to contact HCP. AE Filed (Case #02463498). No additional AE/PQC.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The information on patient's medical history, current conditions and concomitant medications were not reported.  On 29-AUG-2023, the patient received a vaccination of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Therapy Type: rHA) 0.5 ml/dose (valid lot# W024972 with expired date 05-FEB-2024) with expired sterile diluent 1 dosage form (lot# U012698 has been verified to be a valid lot number with reported expiration date: 25-AUG-2023) (no prior temperature excursion) as prophylaxis (both strengths and routes of administration were not provided) (Product preparation issue; Expired product administered). There was no symptoms reported (No adverse event).  This was one of both reports from the same reporter.; Sender's Comments:  US-009507513-2309USA000085: