chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/14/99 pt recv vax on 4/15 erythematous/edematous L thigh w blisters 31/2''x3'', given ice/Motrin, increased to double size w weeping blisters.
No AE; patient received a dose of PEDVAXHIB that was mixed with STERILE DILUENT; 1ml was administered intramuscularly to the patient; This spontaneous report was received from a nurse and refers to a 2-month-old infant.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2022, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 1 milliliter, lot # U093351, expiry date 22-JUN-2024 (strength was not provided) mixed with sterile diluent, solution for injection/infusion, 0.5 milliliter, lot #U024490, expiration date: 02-NOV-2023, administered intramuscularly in their left upper thigh for prophylaxis (strength and indication were not provided) (product preparation error, overdose).  Lot number U093351 is an invalid lot number for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB).  No additional adverse events were reported.
Started shaking inside my body  8 hours after the shot plus a fever of 100. Shaking then turned violent on outside of my body. Took 2 Motrin (225) each. Shaking stopped after 30 minutes, fever disappeared overnight.
This spontaneous report was received from a medical assistant and refers to an unspecified amount of patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates (since July 2014 till at least the end of January 2015), the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot #, expiration date, dose, route of administration and anatomical location were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tdap IM left deltoid at 1045. 02/22/2007 Call to reporter re: ? AE.  Box 7- "possible reaction to Tdap" and  redness around the waist.  02/26/2007 MR received from treating hospital for c/o swelling and tingling in the left arm and hand where he had received DTap vax. earlier in the day.   PE shows mild redness and swelling in the left hand.  No abnormality at the injection site.  Treated with Benadryl and D/C'd. Assessment:  Possible reaction to DTap.
Seen 11/19/10 - 3 weeks of severe tenderness in (L) arm & shoulder/trapezius muscles. Unable to lie on (L) side. No redness, no fever or sxs of infection. Rx- MEDROL Dose pak for myositis -> Resolved but achy after Rx. dose -> Ibuprofen now.
There were no adverse events reported and parent has not returned my call.  When the patient(parent) made the COVID-19 appointment on line, patient's birthday was listed, which made her eligible for the the adult pfizer COVID-19 vaccine(we do not carry the pediatric Pfizer COVID 19 vaccine at this location).  Patient was given 0.3ml of the adult Pfizer COVID 19 for her second dose. Pharmacy was recently notified  that they had patient's  birthday and she should have been given the pediatric version.
LEFT EAR IS BOTHERING; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included exposure to covid.  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 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-JUL-2021, the subject experienced nausea. On 18-JUL-2021, the subject experienced headache. On an unspecified date, the subject experienced left ear is bothering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and headache, and the outcome of left ear is bothering was not reported. This report was non-serious. This case, from the same reporter is linked to 20210742023.
Dizzy/brain fog; Brain fog; tongue tip numbness; lower lip numbness; joint pain; vision blurry; ringing in ears; This is a spontaneous report from a non-contactable consumer, the patient. A 75-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0IS0) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 75-year-old) as a single dose for COVID-19 immunisation. Medical history included candida and sinus infection. The patient had allergy to molds and patient previously took codeine on an unknown date for unknown indication and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN) all for unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 10:45 the patient experienced dizzy/brain fog, tongue tip and lower lip numbness, joint pain, vision blurry and ringing in ears. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy/brain fog, tongue tip and lower lip numbness, joint pain, vision blurry and ringing in ears were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Broke out in hives, had low grade fever, gave Benadryl and Tylenol after3 days seems to be gone
Day of the vaccines (08/13) he had a low grade temperature - highest it got was 99.6°. No redness, no swelling, wasn?t hot to the touch.   08/14 - had a little visible redness that was ?localized? to the shot location, and a bit of swelling. He had a low grade temperature all day long, and complained of a headache. He laid around most of the day, didn?t play much, and said he was tired.   08/15 - swelling is down to just below his elbow, very visible redness, and is VERY warm to the touch. We?ve been applying ice to the area to combat the swelling, but not much happened. I drew around the red areas and nothing seemed to get ?bigger? in terms of redness but the swelling is very visible. He says his arm is sore and doesn?t want anyone to touch it.   We have been applying bentonite clay to the shot area and taking warm Epsom salt baths.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2022 at 2:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Mar-2022 at 2:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Ethnicity was reported. No treatment information was provided. Vaccine administration time 14:20:12 The patient was administered booster dose that went into 2 to 8 Celsius thaw state on or above 24-Dec -2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.   This case was linked to MOD-2022-542869 (Patient Link).
Swelling, irritation, lump at injection site persisting a week after injection. moderate itching. Patient had been taking tylenol and using hot packs. Suggested using cold packs and adding diphenhydramine for itch.
Pt called Medical Call Center to report cough and SOB. Pt was scheduled for appt with urgent care provider
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves nine-weeks old male patient received just the liquid component of the vaccine PENTACEL without the powdered component. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 25-Sep-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number of liquid: C54268A and lot number of powder: C5527AA) (expiry date and dose in series was not reported) via intramuscular route in the left thigh. It was a case of actual medication error due to inappropriate reconstitution technique. It was unknown whether adverse event occurred or not. 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. List of documents held by sender: none.
Had 5-6 minute seizure - due to 100.3 fever accourding to Emergency Room report - eyes rolled back and head flailing slightly, rest of body limp - mom called EMS and was transported, stayed in ER several hours. Information from medical records states irritable, urinary trct infection, post ictal state. msv
Approx 1 1/2 weeks after vaccination started with L shoulder/arm pain. Prednisone started 10/17/08 - completed 10/28/08. Pain better while on Prednisone, but resumed pain 10/31/08.
Starting 06/25/2022, I did an at home test which was negative. I had a really bad sore throat, headaches and congestion. On 06/26/2022, I went to the clinic to get the PCR test which came back positive. I called my doctor the next day on Monday 06/27/2022. They prescribed me PAXLOVID which my husband picked up for me. I took that as instructed and my last dose was on 07/02/2022. The headaches went away pretty fast. I had a very bad sore throat and sort of lost my voice. By Thursday 06/30/2022 I felt better and even better on 07/01/2022. I kept up my fluid intake and sucked on a lot of throat lozenges. Also, I took extra ZYRTEC daily to help with nasal/sinus congestion. By 07/04/2022, I felt basically back to my normal self. The sore throat was the worst part of this infection and by Friday 07/01/2022 I was feeling better and by that Monday 07/04/2022 I was feeling much better.
Information has been received from a RN concerning a 70 + year old female with a penicillin allergy who on 03-OCT-2005 between 9:30 and 10:00 am was vaccinated IM in the left deltoid with a second dose of Pneumovax 23 (lot # 650082/0691P). There was no illness at the time of vaccination. On 03-OCT-2005, at 21:00, the pt developed a hives-like rash, urticaria noted on her left upper arm and on her face and forehead area. The left upper arm was warm to the touch. The pt also complained of nausea. Unspecified medical attention was sought and no respiratory symptoms were noted. The pt was diagnosed with an allergic reaction and treated with Clarinex. It was reported that the pt recovered as of 07-OCT-2005. No product quality complaint was involved. The reporter considered the pt's adverse experience to be other important medical events (OMIC). Additional information is not expected.
Itching, Extreme Upset Stomach with very painful cramps repeatedly for hours, chills, nausea, metal taste in mouth, migraine headache, very sore eyes, eyelids and swelling there and underneath eyes, too, weight loss over 48 hours was 5 lbs., Still itches after 3 days (in left arm where it was given. The diarrhea was terrible-just barely made it to the bathroom, repeatedly over 30 hours. Did not know I was capable of having that much in my intestines when I ate little. The pains were like childbirth. Yesterday I could finally eat toast with jelly.
Two to three minutes after patient received COVID vaccine. Patient had a seizure. He was sitting in a chair while it happened. After a couple seconds patient said he was feeling okay just a little dizzy. Paramedics came and took him to a hospital to be monitored.
This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored doses of M-M-R II, lot #N031294 with expiration date 21-AUG-2019  and PEDVAXHIB, lot #N024570, with expiration date 01-MAY-2020, both for prophylaxis (dose number, frequency, route and anatomical location were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccines had not had any previous temperature excursions. There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007: US-009507513-1808USA011008: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA011014: US-009507513-1808USA006003.
Pt states they were "fine" prior to vaccine administration. Pt was given vaccination and then began to experience immediate partial hearing loss, dizziness and lethargy. Reaction went to assess pt and brought pt water. Pt transported to MO1 on wheelchair. MO1 received 2 sets of VS and both sets were appropriate for pt age and current state. Last vitals taken @ 1655: P: 76, R, 20, BP: 143/84, SpO2: 100%.
Pt developed papular, papulo-vesicular lesions. over face, upper and lower extremities, trunk. Mother stated they increase in number from calling the office to the time she was seen.
Administered both vaccines 10/21/2003.  Burned at time of injection. 10/22/2003: Arm swelling/hot/lack of sleep; 10/23/2003: Area shouting red streaks.  Visit to MD, given Clarinex.  Since then, patient has felt very nauseous, severe headache, while body aches and heartburn with is worse today.
Pfizer Dose 1 1/25/21 (lot NA) Pfizer Dose 2 2/15/21 (lot NA) Pfizer Dose 3 11/2/21 (301308A) Covid Negative 1/14/22 Covid Positive 1/19/22  1/14/22: The patient known to have right lower limp ulcers and history of MRSA osteomyelitis in her right foot status post right transmetatarsal amputation, PAD status post stents to the right superficial femoral artery   Presented with fever and chills and generalized weakness with noticed discharge from the wound in her right lower extremities, decline chest pain or palpitation or dizziness or abdominal pain or nausea or vomiting or diarrhea.   Her wound culture grow MRSA, currently she does have fever, her labs show significant leukocytosis with elevated creatinine from baseline.  X-ray of the lower extremity show erosions.  1/23/22: Patient is admitted to the hospital, started on empiric IV antibiotics with IV vancomycin.  MRI right foot is done which is reported as you focal marrow edema in the 2nd metatarsal may be reactive versus early osteomyelitis. Podiatry consult requested, patient is seen and followed by Dr. Her cultures have been negative.  Patient is tested positive for COVID-19, initially was hypoxic requiring 2 L oxygen by nasal cannula.  She is given empiric IV antibiotics for possible pneumonia, also treated with IV remdesivir and dexamethasone.  Infectious Disease consultation requested, seen by Dr.  and he recommended to continue IV vancomycin.  He also started patient on p.o. Baricitinib.  Patient has improved from COVID-19 infection, has been afebrile and now on room air not requiring oxygen for the last 2 days.  Podiatry has recommended outpatient follow-up, and do not see any need for acute intervention surgically at this time.  Patient also had CT angio of the extremities, results were discussed by the hospitalist Dr.with cardiologist and no intervention was recommended.  Patient is cleared for discharge from ID and the Podiatry Services.  ID recommended IV vancomycin for 6 weeks.  Patient is discharged to skilled nursing facility in stable condition.
Pfizer 1/1/21, 2/23/21, 10/26/21. Positive on 1/19/23
On 12/24/2022, Patient presented to the emergency department due to weakness/fall and testing positive for COVID at home; Her COVID NAA test in the Emergency Department also came back positive; She was not hypoxic and chest x-ray was negative. Patient had symptoms of runny nose, sore throat, cough, and body aches since 12/23/2022. Patient was diagnosed with Covid-19 infection, Acute cystitis, Weakness Fall. She was admitted to the hospital for treatment.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
No adverse reaction, however patient incorrectly got High Dose Flu in place of regular Flu Dose.
COUGH; CONGESTION; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. 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 not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 13:07 for prophylactic vaccination. No concomitant medications were reported.  On 17-JUL-2021, the subject experienced chills. On 17-JUL-2021, the subject experienced nausea. On 17-JUL-2021, the subject experienced headache. On 17-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced cough. On 21-JUL-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, headache, and fever, and had not recovered from cough, and congestion. This report was non-serious.
MOM STATED THAT CHILD'S ARM STARTED WITH A RED/WARM AREA THAT CONTINUED TO GET BIGGER.
Diffuse adenopathy; Elevated LFTs; Intractable hiccups; Fever; Chills; A spontaneous report was received from a health care provider concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed fever and chills, elevated LFTs, diffuse adenopathy and intractable hiccups.   The patient's medical history was not provided. Concomitant product use was not provided.  On an undisclosed date the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   A health care provider reported a patient received the vaccine and 24 hours later experienced fevers (100 to 100.5) and chills. Elevated LFTs after 3 to 4 days of receiving the vaccine. Diffuse adenopathy of abdomen and chest on CT and intractable hiccups.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, fever and chills, elevated LFTs, diffuse adenopathy and intractable hiccups, were considered unknown.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the non-serious listed events of fever and chills and the non-serious unlisted events of diffuse adenopathy, elevated LFTs, and intractable hiccups. Very limited information regarding these events has been provided at this time.  Based on temporal association between vaccination and the onset of events starting one day later, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Patient vaccinated 3/25/2021, states next day in the afternoon developed numbness to right face, arm, leg, and body. No weakness.
No additional AE,; temperature excursion, caller disclosed that multiple doses of MMRlI were administered to multiple patients; This spontaneous report as received from an office administrator refers to a 11-month-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.    On 08-NOV-2020, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status rHA) 0.5 ml injection,"once", lot # S012944 was confirmed to be valid, expiration date 28-APR-2021 (route and site of administration were not reported) for prophylaxis. There were previous excursions reported. The digital data logger was involved. No additional adverse events were reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2101USA000852:Same Reporter Link US-009507513-2101USA000853:Same Reporter Link US-009507513-2101USA000854:Same Reporter Link
Patient was given the Monovalent COVID vaccine, instead of the Bivalent does for her fourth booster injection.
2 patients got full dose instead of booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (2 patients got full dose instead of booster dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (2 patients got full dose instead of booster dose). On 02-Nov-2021, ACCIDENTAL OVERDOSE (2 patients got full dose instead of booster dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided.
No immediate issues noticed with the first shot on 1/19 other than a heachache and pain between by breast on 1/28.  Scheduled stomach and pelvic US and found nothing.    Breast became enlarged resulting in an infection and scar tissue development. Removal of scar tissue and implant was required and not paid by insurance.  I believe the Covid cause this as I was 100% healthy other than a migraine once a month.   Rapid heart rate occurred when sitting down or when slowly jogging.    Could feel the heart beat skip.   I would like to know if this has occurred to healthy woman.