chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She was immediately extremely fussy after the vaccine and hasn't been walking the same way and amount since the vaccine. She has also been miserable and had 4 days of fevers. She had 2 episodes where she was staring into space and twitching and we have since made an appointment to see a pediatric neurologist. This never has happened before .
Initial unsolicited report received from nurse on 05-Oct-2018. This case is linked to case 2018SA279686. This case involves an eight years old (unknown gender) patient who was vaccinated with a 0.5 ml dose of IPOL (Batch number: N1K92, expiration date: 14-NOV-2019, route: subcutaneous and site of administration: left thigh) on 24-Sep-2018. Concomitant medications included TDAP and HEPATITIS A VACCINE. The patient's medical history was not reported. It was an actual medication error due to incorrect product storage (vaccinated with an IPOL multi-dose vial that was out of temperature range for 30 minutes). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Patient unable to work on 12/24/2020 - fever of 101.0, muscle ache, nausea, diarrhea. 12/25/2020 some better, fever persists at 99.8, and diarrhea 12/26/2020 better, no fever, still has diarrhea 12/27/2020 better, no fever, still has diarrhea 12/28/2020 better, no fever, small amount of diarrhea.
I received the Pfizer vaccine booster on Thursday, 11/4. I had an immediate reaction (within couple minutes) that my inside of my throat (trachea or esphagus) felt swollen. I did not say anything to anyone at the time because it did not affect my breathing. Approximately 3 hours later, it appeared to let up and be better. However, in 12 hours it returned. Over the weekend, it would come for about 4 hours and go away for a few hours and follow this cycle. By Monday, 11/4, this feeling in my neck (swelling sensation in my trachea or esophagus) was there more often. I also developed a ?full? feeling in my ears. I went to an Urgent Care on Monday and they put me on a burst of prednisone (60 mg  the first day, 40mg for 2 days, and 20mg for 2 days. I also was told to take Benadryl tablets with the prednisone. The first day or 2 I thought it may have helped a little; however, today the swelling sensation in my neck is always there. My ears popped periodically today and the fullness in my ears is better than it was and doesn't really bother me, but my swelling sensation in my neck remains. Sometimes for a short period of time,I feel that my jaw and under my chin is getting tight.   My oxygen saturation is good (no problems at all) and my breathing is good.
I had both vaccines injected on the left arm. The first one was on Feb 5th. My arm got very sore at the site of injection the next day for about 24 hr.  I started to notice pulsation on my ears. Then as the days went by, this turned into hyperacusis and I consulted about it on Feb 26th. the day of the second shot.. My physician referred me to an ENT. I saw the ENT on Feb 29 and had a hearing test the same day, they found no signs of hearing loss or abnormal conditions. I was diagnosed with pulsation tinnitus and hyperacusis.  After the second dose, I had a skin reaction. I had redness at the site of the injection and developed a blister the same day. Then, two days later I noticed a swollen lymph node on the left side of the neck. My arm was very sore from the injection again. I noticed that the joints on my right arm are in  acute pain.
noticed unusual color and order of my urine that same day next day i started having mild urinary tract infections. went to urgent care and got test done for urinary tract infection   received a 10 day supply of antibiotics.  cleared up until about 2 month after when i noticed  last friday i  had blood in urine. ongoing investigation .
This patient had severe pain in her right arm at the site of vaccination. Unable to raise her arm. The pain radiates length of arm. Cannot lift items.
Fever, myalgias, headache started about 14 hours after vaccine. Fever as high as 102.8. Subsided after 36 hours. Unable to go to work the day after the vaccine due to high fever.
Sore throat/SOB, wheezing, red blurry eyes, low grade fever. Tingling/sore at site of inj. after inj x 20 min.
Pt recvd vax 9DEC92 & exp pain which radiated down arm to fingers & up arm to neck & across chest; pt exp persistent pain w/sl swelling & redness @ inject site for a few days; 11DEC92 pt exp pain upon lifting lt arm; pt was seen by MD;
Information has been received from a 67 year old female with "allergies", penicillin allergy and irritable bowel syndrome who on 14-JUN-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck) (lot # 657559/0462U). Concomitant therapy included ZYRTEC, CLIMARA and DONNATAL. On 18-JUN-2007 the patient experienced a rash which the patient felt was shingles. The rash developed on her right side from the waist to the shoulder blades and it crossed over to the midline of her left side, also from the waist to her shoulder blade. On 29-JUN-2007 she saw her physician who did not feel that she had shingles, but had experienced a reaction to the vaccine. It was reported that the patient was recovering on an unspecified therapy. An unspecified blood test was performed (results not reported). Additional information has been requested.
Information has been received from a consumer concerning a male with "pediatric asthma as a baby" and no drug reactions/allergies who on 15-APR-2002 was vaccinated with a dose of MMR II (Lot # 640634/1093L). Concomitant therapy that day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, COMVAX, and PEDVAXHIB. In May 2005, the patient experienced autism. The patient had "blood work". The mother feels her son is autistic due to the "toxicity of the vaccines". The outcome is not recovered. Unspecified medical attention was sought. There was no product quality complaint. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.
COUGH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced cough. Treatment medications (dates unspecified) included: guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough. This report was non-serious.
Received Pfizer vaccines on 4/1, 4/22, 10/28/21 COVID-19 positive by PCR on  1/31/22 admitted to hospital on 1/31/22 d/t COVID infection, weakness, suspect pneumonia underlying MS
The dizziness and headaches started about 12 hours after the  booster vaccine. I took a nap. About a month later, I experienced the same type of headaches. The last time I experienced the dizzy feeling, nausea & headache was now in March. I?ve been doing acupuncture to remedy the situation. It has helped me recover after a couple of sessions! The headaches nor nausea haven?t returned since two weeks ago when I had an acupuncture session.
My arm became increasingly sore the first day- hard to raise by late evening. The next morning when I woke up about 24 hours from when I got the shot, it was a bit puffy and soreness increased- I could not touch it w/out significant pain nor raise it above my ear (to brush hair/shower). It was a bit warm but not too bad. I was nauseated all day - unable to eat more than a bowl of cereal. Throughout the day I had an intermittent high fever with chills and some shaking.i had increasing body aches, headache, and limited focus. By evening the nausea was worse. The pain in my arm woke me several times during the night and my fever increased (not sure of the number but I was hot to the touch and very pink.. On Sunday the temperature went down but the nausea remained as did the aching.  I also got a patch red rash that looked like a hand slap around the injection site. That night I had diarrhea throughout the night and intense stomach cramps. On Monday, I am better but my arm is still a bit puffy and the re patchiness is now itchy.
At 2pm I was at work and packed my things like I was going home. A friend saw me and told me it wasn't time to go home. At this time she took me to my office and I realized I was confused. When I got home on the 3rd of February I had a fainting spell.  I had headache on the left parietal and temporal lobe. The headache was the worst headache of my life.  It lasted for 7 days. It was throbbing and pulling constantly. It felt better when I was sleeping. The left side of my head was warm. Upon waking up, my headache would return. On day 7 all symptoms resolved.   I went to my physician (Via phone visit)  and she has ordered me an MRA w/o contrast  head  which is now pending.
Progressive neurologic weakness.  Likely Guillain-Barre Syndrome.  Admitted in PICU currently.
DOA in hosp ER 14FEB99;blood cult grew H. flu type B;
Johnson & Johnson one and done. Around four days after the shot, I started experiencing weakness throughout the body. Energy levels way down. It has not changed since. Just got worse December 2021. I finally went to a doctor on 4/15/2022, who referred me to a heart doctor. At the present time: loss of energy and irregular heartbeat. I had SARS two years ago. I think the vaccine might have reacted with previous SARS infection and affected my heart.
One hour after PCV-13 vaccine administration IM on left thigh, hives were noticed on both cheeks and both hand, dorsi, with swelling and redness at site of injection. There was no fever, no itching and no change in patient's condition. She was her usual self. Rashes faded in 3 days.
My dad has been acting abnormal since he got the 2nd shot; Involuntary movement; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (My dad has been acting abnormal since he got the 2nd shot) and DYSKINESIA (Involuntary movement) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABNORMAL BEHAVIOUR (My dad has been acting abnormal since he got the 2nd shot) and DYSKINESIA (Involuntary movement). At the time of the report, ABNORMAL BEHAVIOUR (My dad has been acting abnormal since he got the 2nd shot) and DYSKINESIA (Involuntary movement) outcome was unknown.            No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Information has been received from a registered nurse concerning a 14 year old female who "two weeks ago" on 16-MAY-2007 was vaccinated with her first dose of Gardasil 0.5 ml intramuscularly. After receiving the vaccination on 16-MAY-2007, the patient turned white, grabbed her mother's arm and then fainted. Subsequently, the patient recovered. Additional information has been requested.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 16-APR-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature)for a total of 1344 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. On 17-FEB-2014, the patient was vaccinated with GARDASIL dose 3, .5 ml, intramuscular. The nurse was reporting that the patient was administered the first dose of GARDASIL in December 2010, the second dose of GARDASIL in February 2011, and the third dose of GARDASIL on 17-FEB-2014. No adverse effects were reported. Additional information has been requested.
Patient Called 02/06/21 and said she was running a fever and chills from the shingrix vaccine
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days." There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Child presents in clinic today with (L) arm that is swollen, red & warm to touch at deltoid muscle area. Mother states picked up from school on 8-16-11 at about 2:00 & noticed that child's arm was swollen, red & hot to touch & took child to ER that afternoon for evaluation. Mother states that they gave child some BENADRYL for the reaction & told her to f/u here at Health Dept. today (8-17-11). Explained to mother to put cold compress for discomfort on arm & to give child Children's TYLENOL or Ibuprofen OTC as directed on bottle if needed. To come back if symptoms worsened.
I didn't know exactly when the adverse event started. I noticed the symptom 2 or 3 days after the vaccination: under-skin bleeding in both inner-side of my thighs. There is no pain, no itching or other symptoms other than the bruise on my inner thighs. Now 7 or 8 days has passed, the bruise color is lighter and looks like getting better. I didn't seek treatment.
Patient received INFLUENZA vaccination. Shortly after, patient experienced swelling in the arm at site of injection once she went home. Swelling continued to persist until the next few days. Reaction site was warm and tender to touch, despite patient taking BENADRYL and applying topicals.
This spontaneous report was received from a physician, referring to an unspecified 11 year old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The physician reported that on an unspecified date the patient inadvertenly was vaccinated with GARDASIL 9 (strength, dose, route of administration, frequency, lot number and expiration date were not reported) for prophylaxis; and the vaccine was not intended to be administered to this patient.  The physician denied any adverse effect reported by the patient. There was no PQC involved.
From initial information received on 10/02/03 from a physician regarding an adverse event occurring in the USA, it was reported that a 5 year old male pt received his fifth dose of IPOL (Lot # W1002 and expiration date 09/05/06) administered in the left deltoid on 09/30/03.  The route of administration was not reported. On 10/01/03, the pt developed an 8.5x7.5 area of redness with swelling. It was not reported whether the child was seen by a physician, however, the was prescribed Keflex for cellulitis. The pt's recovery status is unknown.
I had signifigant delays in my period after the second vaccine shot. I track my period every month. It is typically between 22-27 days. For the two months following my shot, it was 44 or 45 days between periods. It was long enough of a delay where I took a pregnancy test each month. I also spoke to my doctor about it. She said it was typical to have an immune reaction after a shot like this. I still wanted to share it.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-MAY-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 64 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Suspected vaccnation failure; shingles /suffering terribly/ nasty; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On 20th April 2019, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient received 1 shot version in 2018. The vaccine only lasted about 5 years and they did not give another vaccination or booster.  The patient had 2nd dose on 20th April 2019. After receiving 2 doses of Shingles vaccine, the patient had shingles at the time of reporting. The patient stated that, it was 97 percent effective and he/she fell into the exception 3 percent. This case was considered as suspected vaccination failure, since the details regarding laboratory test confirmation was not provided.
Large red area with warm at injection site.  Advised to use cold pack and Benadryl and follow up with Dr. if not resolving.
Patient presented for COVID-19 Vaccination.  Her registration form was checked, DOB verified and screening questions asked. Pt. offered that she has "vagal responses" in the past including fainting to injections, blood draws and eye dilations. She received the COVID-19 via 25 gauge syringe in the right deltoid. She denied any signs or symptoms of light headedness, visual changes.  She was given the CDC card and instructions to check in with the medical attendant and proceed to waiting area.   She was instructed to let the medical attendant know if she felt any of the signs and syptoms she described as preceding her previous vagal responses.  Client was seated in the waiting area and started to walk towards the exit monitor when she fell backwards on the floor.  Staff and a paramedic assisted immediately.  Patient was taken to ED due to blood pressure being low.
ABDOMINAL PAIN; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced fever, and abdominal pain. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and abdominal pain was not reported. This report was non-serious.
MILD BODY PAIN / SORENESS; CHILLS; FEVER; MILD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced mild body pain, soreness, chills, fever, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild headache, mild body pain, fever, chills and soreness was not reported. This report was non-serious.
Leg pain from the knee down; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain from the knee down) and NECK PAIN (Neck pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain from the knee down) and NECK PAIN (Neck pain). At the time of the report, PAIN IN EXTREMITY (Leg pain from the knee down) and NECK PAIN (Neck pain) outcome was unknown.            The reporter  stated  that his mom takes Tylenol and the pain goes away.