chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    No concomitant medications were provided. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 113 Bivalent doses administered after the BUD to patients 12 and up. 60 doses from Lot AS7148B. No treatment medication was provided.
Dose was given 7 days early and patient experienced nausea and vomiting 16 hours later.  Back to normal the next day.
As 1st time parents, our son's symptoms were not obvious to us right away. By the time he was a year old, he had started hand flapping and toe walking. We were told that we needed to keep an eye on this by his aunt, a psychiatric social worker who has had experience with autistic children. Following his 1st birthday, the developmental delays became more and more obvious. He never stacked blocks, for example. By the time he was 18 months old, it was very obvious that something was wrong, even to his inexperienced parents. He was dx'd with autism at two. Eventually, his babbling and the few words he had acquire disappeared. Later, we learned that the inoculations might have been a factor in his autism. He received vaccines up to the age of 18 months; however, I am especially suspicious of the inoculation administered prior to a year. These vaccines were given on 5/2/94, 7/7/94 and 9/94. Autism-lack of speech, self-stimming behaviors, lack of eye contact, digestive problems, etc.
On MAIO. Severe depression started evening of day after shot (Saturday) and continued until mid-day Monday.   Worst in many years.
Fussiness on the evening of immunizations. The next day, she developed an erythematous, macular-papular rash on face, trunk (anterior and posterior) and extremities; none on palms/soles. Afebrile and without other signs of illness.
Pfizer vaccine was administered after being discovered the vaccines were in the freezer for 11 days after the two week standard time.
101 fever for 4 days, breathing problems  dizziness for months and an inflammatory and central nervous reaction. I?m still recovery from severe respitory reaction after 3 months.
Pain upon injection, in 24 hours, hot, red, swelling.  These symptoms dissipated, then pain into arm to wrist and under arm.  TX: arm sling, cortisone P.O.
numbness in her tongue; weird taste in her mouth; on and off chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL, TASTE DISORDER, and CHILLS in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001V21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HYPOAESTHESIA ORAL, TASTE DISORDER, and CHILLS. At the time of the report, HYPOAESTHESIA ORAL, TASTE DISORDER, and CHILLS had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Difficulty Breathing; Heart Palpitation for two and half days; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), PALPITATIONS (Heart Palpitation for two and half days) and DIZZINESS (Dizziness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 23-Feb-2021, the patient experienced DYSPNOEA (Difficulty Breathing), PALPITATIONS (Heart Palpitation for two and half days) and DIZZINESS (Dizziness). At the time of the report, DYSPNOEA (Difficulty Breathing), PALPITATIONS (Heart Palpitation for two and half days) and DIZZINESS (Dizziness) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided. Patient treatment information was not provided.
Fever to 102.6 with erythematous macular rash over thorax, head and arms, itchy.
Got covid after booster; Got covid after booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Got covid after booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SLIGHT HEADACHE PAIN AT SITE OF INJECTION PAIN IN LEFT ARM PIT AREA WITH SWOLLEN GLANDS (LARGE KNOT)
flu; Initial information was received on 13-Dec-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via media.  This case involves a patient (age and gender not specified) who had flu (influenza), while patient received INFLUENZA VACCINE.  Medical history, medical treatments, past vaccinations, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE one time and it was only time in 72 years that he/she had flu.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Flu shots were administered free at my work today.  I got the shot, as I do every year.  About 10 minutes after the shot, my face and mouth went numb, my vision blurred to nearly total blackness and I nearly passed out.  I made it to a chair and sat with my head down for a moment, at which time my heart started racing, I became hot and started sweating.  I felt weak, dizzy, and nauseated for at least 30 minutes to an hour after.  The nurse who administered the shot told me that it was because I hadn't eaten and that I should not take a flu shot on an empty stomach.  I have never been instructed to eat prior to a vaccine so this sounded suspicious to me.  She seemed unconcerned so I called my doctor's office.  The nurse there told me she had never heard of such a reaction and if I continued to feel bad I should go to the ER.  I have improved as the afternoon progressed but still feel weak and a little tingly.  I have never had a reaction like this to a flu shot, or anything for that matter.  Now I am fearful that I will develop subsequent complications.
Began to feel feverish around or slightly before 9:30, when chills & shivering began.  Could not sleep due to shivering.  Got up around 1 AM to go to bathroom- was VERY weak & needed help.  Also while getting to bathroom began to lose control over kidneys and was urinating involuntarily.   Had urge to to go the bathroom again around 3;  30.  This time could NOT walk at all & was once again urinating involuntarily.  Tried to just go back to bed, but did not seem to have any control over my body.  Around 4:30 I got as comfortable as possible on the floor & slept  off & on until around 8:30.  When I woke up I was able with  help to get back into bed. I had continued to urinate involuntarily during the time I was sleeping prior to 8:30.   The symptoms seemed to gradually subside after this point.  Called Neurologist,  thinking that my radiation induced nerve damage was involved in my reaction and she agreed.
Grandmother reports that he had fever of 101 degrees F on 11/17, fever broke on 11/18 around 6 PM, on 11/19 broke out in light red non-raised scattered rash on head, face, back and trunk. On 11/21 Rash no longer visible. No treatment done.
After receiving the shot, I experienced: -severe headache + bodyaches  -injection site swelling and pain -fever for 2 days of 99.9 (my norm is 97.1) -left armpit swelling + a very painful pinching -fatigue -nausea + loss of appetite
Information was received on 17-JUL-2017 from a physician who was reporting on a female patient of unknown age. No medical history or concomitant medications were reported. The physician reported that on 17-JUL-2017, the patient inadvertently received an expired dose of MMR II (lot M032153, expires 22-APR-2017, dose, route and site not reported). No adverse effects reported. Additional information has been requested.
When I was released from waiting in the drive line for the 15 minutes I pulled away and for the strangest unknown to me reason, I  began yawning... Like non stop yawning for the next 40 minutes and then it stopped. Just as fast as it started, it stopped.  I was telling a friend about my weird experience and she said I should report it even if it sounded insignificant.
This case was reported by a physician and described the occurrence of facial palsy in a 18-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), HAVRIX and MENACTRA (non-gsk). On 7 July 2009, the subject received unspecified dose of BOOSTRIX (unknown), unspecified dose of HAVRIX (unknown), unspecified dose of MENACTRA, the subject experienced partial facial palsy. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
injection site extremely painful, mild headache, fever of 100+ that gave me full body shakes, fatigue - i fell out of my chair. i didn't see another blank for this but i tested positive for covid 19 i got sick march 2 of 2021
Pt began experiencing bilateral leg pain and swelling. Bilateral US today reveals DVT of right calf through mid superficial femoral vein and DVT of left popliteal and left superficial femoral vein.  Patient placed on Eliquis.
Fever; Chills; Body aches for 12 hours; This is a spontaneous report from a contactable consumer, the parent. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 10Apr2021 at 10:30 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 09:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was 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 10Apr2021 at 22:00 the patient experienced fever, chills, and body aches for 12 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, and body aches for 12 hours were recovered on 11Apr2021.  No follow-up attempts are needed. No further information is expected.
Redness, edema, hot to touch LD Tx with KEFLEX, DECADRON, BENADRYL - did not take BENADRYL.
2 hours after MMR vaccine numbness in lower extremities foot drop bilaterally 12/31/07-records received for DOS 10/24/07-After vaccination suffered an MS attack day after vaccination. Manifested itself with leg weakness and some numbnes. Not worked since then. Right foot drop and unable to dorseflex. Impression: Multiple sclerosis exacerbation. Per 60 follow up: R & L leg weakness & numbness.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/4/2023 MATERNAL DELIVERY OUTCOME, TWIN BIRTH, BOTH LIVEBORN
Exposed on 10/20/2021. Two days later I started to have a stuffy nose, headache and sore throat. I had cold like symptoms. The next morning I decided to get tested at a drive through test site on 10/24/2021. On 10/25/2021 I received my test results and they showed I was positive for COVID. 10/25/2021 I called my doctor to get a referral for a monoclonal antibodies since I was out of town. On 10/27/2021 I received Regeneron monoclonal antibodies infusion from the Hospital. On 11/01/2021 I went to the emergency room due to chest pains. The doctor listened to my lungs and stated they sounded clear. He told me to take Robitussin DM and that definitely helped. I took another COVID test on 10/31/2021 and it showed I was still positive. After about 3-4 weeks I was almost back to normal, but my sense of taste and smell is still not back to 100%.
No adverse effect reported.; a male patient received properly stored M-M-R II and properly stored VARlVAX intramuscularly in the right deltoid instead of subcutaneously; VARIVAX was given concomitantly with MMR II; This spontaneous report was received from a nurse concerning a currently 17 years old male patient. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 29-AUG-2019, the patient was vaccinated with properly store Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) recombinant human albumin (rHA) lot number R029513 with expiration date on 14-OCT-2020 and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R024024 with expiration date on 22-AUG-2020 (inappropriate schedule of vaccine administered) booth vaccines were administered intramuscularly in the right deltoid instead of subcutaneously (inappropriate route of vaccination) for prophylaxis (exact doses, and frequencies were not reported). The vaccines were reconstituted with properly stored sterile diluent (lot number S000978 with expiration date on 22-JUL-2021). No adverse effect reported.
Case previously recorded as MA2009-6440. We received the following information via Medical Communications (MedCom) from a physician on 30 NOV 2009: Three patients younger than four received a dose of S-OIV FLUVIRIN (batch number 1007369P) i.m. on an unspecified date. Despite multiple attempts to obtain details such as patient initials the reporter declined to provide additional information. No adverse effects was reported. This case concerns one of the three patient for the other two children please refer to cases MA2009-6438 and MA2009-6439. No seriousness criterion given. MedCom ref. no.: NA09-008948.
Remained with pain / at the injection site; Remained with pain / muscle weakness; Muscle stiffness; Is limiting range of motion; Is painful; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received HAV (Havrix) (batch number 3C7ZG, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th September 2020, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, less than 6 months after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced injection site pain, muscle weakness, muscle stiffness, mobility decreased and pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the muscle weakness, muscle stiffness, mobility decreased and pain were unknown.   It was unknown if the reporter considered the injection site pain, muscle weakness, muscle stiffness, mobility decreased and pain to be related to Havrix and Havrix Pre-Filled Syringe Device.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was administered Havrix first dose and remained with pain and at the injection site and muscle weakness.  The patient did not have induration. The patient had muscle stiffness that was limiting range of motion and after a while was painful. The reporter did not consent to follow-up.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a first one of Shingles vaccine and had shingles in less than a year. The follow up could not be possible as no contact details were available.
Initial report received from a health care professional on 04/11/2006. A 44 year old female patient developed constant coughing the same day she received the intramuscular injection of Adacel, lot number C2384AA (sit of administration not reported) on 04/10/2006.  Per reporter, the patient will be seeing her primary care physician. Treatment was not reported. At the time of this report the patient had not recovered.
I had issues with my period with my first vaccine, and it also happened with the second vaccine. I started to feel sick right after the vaccination. I went to a walk-in clinic where I can check my blood. I noticed that I had thyroid issues. I got in contact with my provider from overseas, and they helped me with the issue over telehealth visit. He read my results and he asked that I take another test. They asked that I take levothyroxine 50 mcgs daily.
patient broke out into a sweat all over, face lost color and had a low heart rate (51bpm) per patient he felt the same way he felt after getting a rocephin shot and he passed out which happened to him twice - he did not pass out this time but he said it felt like he was going to pass out. Patient observed, given cold water to cool down and looked over by EMS which released patient to go but he couldn't drive himself home.
Sedation, Myalgia, Arthralgia, Fever Sweats, Narrative:  After 2nd dose on 3/12/21 noted onset of fever (up to 102F), sweats, myalgia, arthralgia, and fatigue. Symptoms started within 12 hours of administration and lasted about 8 hours. Had history of COVID infection 10/2020, which required hospitalization x 5 days.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site redness in a 61-year-old female patient who received SHINGRIX (batch number D9474, expiry date 10th September 2021) for prophylaxis. On 26th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th February 2019, 1 days after receiving SHINGRIX, the patient experienced injection site redness, injection site pain and injection site lump. On an unknown date, the outcome of the injection site redness, injection site pain and injection site lump were not recovered/not resolved. It was unknown if the reporter considered the injection site redness, injection site pain and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The pharmacist reported that the next morning after vaccination, the patient experienced redness at and around the injection site about 1 inch in diameter, along with soreness and a knot underneath the injection site. The patient did have the side effects at the time of reporting. No further details were provided.
Transient well-circumscribed erythematous wheals in clusters over arms, chest, back, legs; BENADRYL 50mg & ORAPRED 30m once each day x 3 days.
I started feeling that my heart rate is not steady and it?s very irregular. I had trouble sleeping from my heart beata for 2 weeks and I thought it was stress or anxiety. I went to see a doctor, they drew blood and then called me after 2 days and said I had to go to the ER because Troponin level was so high. I went to the ER and they kelt me at the hospital for 30 hours to monitor my Troponin level and they did and ECG and Echocardiogram. They said it was Pericardial effusion and Pericarditis. They prescribed me Ibuprofen 400 tid and my doctor have me Propranolol 20mg qd.
This spontaneous report as received from a pharmacist refers to a 68 year old male patient referring on himself with no pertinent medical history and concurrent conditions. On 08-OCT-2014, the patient was vaccinated with ZOSTAVAX 19400 PFU. Dose, route, lot number and expiration date were not reported. Concomitant therapies included methocarbamol, risperidone, clonazepam, FLOMAX and VOLTAREN. On an unknown date in 2014 the patient developed shingles. The outcome of shingles was reported as not recovered. The patient was treated with acyclovir and NORCO. No lab diagnostics studies were performed. The patient sought medical attention. Additional information has been requested.
A report has been received from a Physician concerning a 1 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 04-Nov-2013. It was reported that MedImmune representative inadvertently administered FLUMIST QUADRIVALENT to 13 month old male patient which started on 04-Nov-2013. The outcome of the event of ADMINISTRATION TO 13 MONTH OLD is unknown. The report was considered to be non-serious.