chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 12 year old female patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 08-DEC-2016, the patient was vaccinated with GARDASIL 9 lot # M024261, expiry date: 30-JUL-2018 for prophylaxis under the assumption that it was the patient's third dose but after review of the patient's chart, it became evident that it was actually the fourth dose (extra dose administered). No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
Localized cellulitis like reaction with erythema, induration and increased heat in affected area.
Right leg has involuntary movements; 104 temperature; Proning headache on the right side of the head,"Headache and vomiting were horrible"; Vomiting,"Headache and vomiting were horrible"; Seemed like patient was having a seizure; "I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication; "I was deathly ill, never felt so ill"; Dehydrated; This spontaneous case was reported by a nurse and describes the occurrence of SEIZURE (Seemed like patient was having a seizure), FEEDING DISORDER ("I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication), ILLNESS ("I was deathly ill, never felt so ill"), DEHYDRATION (Dehydrated) and DYSKINESIA (Right leg has involuntary movements) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced SEIZURE (Seemed like patient was having a seizure), FEEDING DISORDER ("I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication), ILLNESS ("I was deathly ill, never felt so ill"), DEHYDRATION (Dehydrated), PYREXIA (104 temperature), HEADACHE (Proning headache on the right side of the head,"Headache and vomiting were horrible") and VOMITING (Vomiting,"Headache and vomiting were horrible"). In April 2021, the patient experienced DYSKINESIA (Right leg has involuntary movements). On 31-Mar-2021, SEIZURE (Seemed like patient was having a seizure), FEEDING DISORDER ("I had nothing on stomach but kept vomiting",Couldn't drink water or eat anything nor take any medication), ILLNESS ("I was deathly ill, never felt so ill"), DEHYDRATION (Dehydrated), PYREXIA (104 temperature), HEADACHE (Proning headache on the right side of the head,"Headache and vomiting were horrible") and VOMITING (Vomiting,"Headache and vomiting were horrible") had resolved. At the time of the report, DYSKINESIA (Right leg has involuntary movements) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 29-Mar-2021, Body temperature: 104 temperature (abnormal) 104 temperature.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported.No treatment medication were provided.
Vaccine was given 2 days past the beyond use date.  It is only supposed to be stored in the fridge 30 days, and it was given on day 32.
Patient received COVID-19 vaccine.  Five minutes later, developed redness and swelling around vaccine administration site in left arm.  Patient complaining of itching.  No difficulty breathing, dyspnea, etc.  Weight today 50 pounds.  Patient has done well with other vaccines in the past  Given 10 mL children's benadryl.  Improvement in itching.  Stable.  Emergency precautions reviewed with mother.  Give children's Benadryl 10 mL nightly over the next 2-3 nights.  Would not advise on continuing COVID vaccine series given quickness of reaction.  Follow up as needed for any acute concerns. 12/31/21 rash has returned from her allergic reaction to the covid vaccine.  it's on her arms and legs. She is not having any difficulty breathing.  I gave her benadryl dose to her early this evening which helps it go away.  As of 1/3/22, still using benadryl to control rash as it returns when therapy is stopped. In person follow up physician visit today.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with a COPD exacerbation.  Vaccination took place on 9/19/07 and hospital admission was on 11/06/07. According to physician, relationship to treatment is 'None'.  We would be happy to forward the Study's SAE Report Form upon request.
Sudden hearing loss, left ear, onset 6/2/2021.  On 60 MG prednisone taper, starting 6/6/2021
Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Nausea-Mild
10/1/2021 stood up and had horrible headache.   Went to bed and woke up at approximately 6 am and my left side of body, including face, was numb.  Went to hospital.  Hospital admitted me and treated as stroke.  Did CT scans and MRI and echocardiogram.  Imaging was within normal limits, however diagnosis was a CVA (stroke).
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On unspecified dates the patients were vaccinated with improperly stored ROTATEQ (dosing regimen unspecified) (L008059 (also reported as 1008059), exp: 18-DEC-2016). No concomitant medications reported. No adverse effects reported. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
No symptomatic side effects reported; the product was frozen and was inadvertently administered to patients; a shipment of DILUENT arrived a day later than it's "receive by" date.; Product reconstitution quality issue; This spontaneous report was received from a health care professional referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 21-DEC-2022, a shipment of sterile diluent (STERILE DILUENT) Solution for injection/infusion (lot# W000447, expiration date 07-MAY-2024; strength, dose, route of administration and anatomical location were not reported) arrived a day later than it's "receive by" date (product distribution issue) and had a "freeze" indicator that stated the product was frozen (product storage error) which was not quarantined and was inadvertently administered to the patient, and reconstituted with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (lot# W026326, expiration date 18-FEB-2024; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product reconstitution quality issue). No symptomatic side effects reported. No additional adverse events details or product quality complaint (PQC).
12 hours after - fatigue, headache  36 hours after - mild chest pain, shortness of breath, got very nauseous and lightheaded during a mild yoga class and had to stop, chest pain and shortness of breath has persisted even after stopping physical activity  (waiting to see if I need to go to the hospital)
Pt states that day after vaccine starting having pain, swelling and redness at injection site, a week after pt started having itching and continued swelling.
Dose given after exposure to freezing temperature; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received HAV (Havrix) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.   On 08-NOV-2023, the patient received Havrix. On 08-NOV-2023, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Dose given after exposure to freezing temperature). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-NOV-2023 The reporter inquired about Havrix and what information was available about the administration of Havrix after the vaccines were exposed to freezing temperatures and administered, which led to incorrect storage of drug. They gave partial information about vaccines, patient and event. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
This spontaneous report was received from a physician and refers to a 16-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was inadvertently administered GARDASIL 9 lot # M041990, expiration date 268-JUN-2019 (dose, dose number, route of administration and anatomical location were not reported). No adverse effects were reported. The physician confirmed that it was a medication error and not a product confuse error. No product quality complaint was involved. Additional information has been requested.
Patient received the first injection of SHINGRIX on 01/19 around noon and later that evening she had some achiness, malaise, stiff neck, pain at the injection site. As time went on, she experience right ear and right eye swelling and also itching. The itching was at the same site on top of her head where she had shingles in the past. She also reported the roof of her mouth being sore and having some swelling in her mouth. She stated she was not able to wear a dental appliance because of the swelling. The patient was treating the pain and soreness with over the counter ibuprofen. No visits to the doctor was reported.
Next day after taking Modena vaccine, experienced redness, swelling, and hardness around injection site. Also chills and a headache throughout the day .... 01-17-2021. My lot number was reported in media as experiencing  side effects  and I felt I needed to report my side effects.
c/o muscle aches all over body; neck hurts started day of immun 19MAR92; rash on arms where inject given started tody 23MAR92;
Feeling light headed of and on; Whole body sore; Tired; He just felt sick this morning; Felt warm; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9264; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 02Feb2021 14:00 as 2nd dose, single dose; dose 1 on12Jan2021, in his right arm as 1st dose, single dose (Lot no: EL3302) for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took bnt162b2. on 03Feb2021 the patient experienced feeling lightheaded off and on, whole body sore, tired, he just felt sick this morning, felt warm and He felt like he got tackled or hit by something. Therapeutic measures were taken with Tylenol and the patient felt better. The clinical outcome of the events Feeling light headed of and on, He just felt sick this morning was Not recovered/Not resolved and Whole body sore, Felt warm, Tired was Recovering/Resolving.  Follow-up attempts are completed. No further information is expected.
I woke up the night after the shot with difficulty keeping my breath even and feeling weak which led to pretty high anxiety. This went away after a few hours
Parents state knot appeared on right leg shortly after injection was given and area became reddened. Child taken to doctor who prescribed anti-itch cream. Parents returned with child to local health office after affected area began to worsen. Advised to return to doctor's office for prescription of antibiotics.
Left arm swollen, red, & hot day after.  Pain shooting down left arm 3 days afterwards. Developed shortness of breath with minimal exertion, such as talking for extended period of time.
I received the vaccine at 9:15am on 4/7/21. Later that night at midnight, I woke up sweating with a high fever of 101. I had chills, a headache, fatigue, and nausea. The chills were severe. I couldn't get much sleep. In the morning and throughout the next day, I maintained a fever between 99 and 100 and felt fatigued and loss of appetite. I took 2 iBruprofen at 200mg each ever 4-6 hours. The fever never broke. I took NyQuil at 8PM on 4/8/21 to subdue the fever. I had night sweats and slept through the night. Today on 4/9/21 I have no fever. Although,  my arm is swollen at the injection site, red, and in pain. I am icing it and moving it around to subdue the swelling.
Subsequent to receiving two doses of varicella virus vaccine live, pts laboratory evaluation revealed a lack of response. Laboratory evaluation revealed varicella zoster surface antibody 0.38.
2 wks after receiving the MMR and Varivax vaccinations on 10/8/03; pt developed a high fever (104), rash on body and diarrhea.  Fever and rash persisted for 3-4 days; chronic diarrhea persisted for 2 years;  2-3 months after the vaccinations, pt developed neuro sxs--abnormal tone and toe walking.  12/7/07 Received vax record which confirms dose/lot as reported.  1/8/08 Reviewed pcp medical records which reveal patient experienced lack of communication skills including gesturing, fleeting eye contact, fine & gross motor skills delay, pacing, toe walking & social skills delay.  Patient was evaluated at genetic & metabolism certer 4/17/06 & it was noted that he already had a dx of autism & speech/language delays from a neurologist.  Immunology testing revealed caesin sensitivities & several elevated metabolites w/o specific pattern.  MRI, CT scan chromosome study & hearing tests were all WNL. FINAL DX: autism spectrum disorder; significant speech & language delays; fine motor delay; elevated metabolites. Per 60 day follow up: Exhibits signs of neurological damage - hypertonicity & coordination deficits L arm/leg; toe walks; motor & speech apraxia. The CDC & AAP needs to do a better job of educating physicians on Pt population that are at higher risk of adverse reactions - ie family hx of immune regulation probs. 1/15/2010 Continues to exhibit unilateral weakness and coordination deficits (MRI rulled out CVA/tumor); toes walks (ambulatory prior to vaccine and did not toe walk); continues to have GI problems; apraxic speech; cognitive deficits.
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. In February 2011 and in July 2011 the patient was vaccinated with first and second doses of GARDASIL respectively (doses, route, and lot numbers not provided). The patient did not get the third dose yet, at the time of the report. NO adverse effect was reported. Additional information has been requested.
Started feeling unwell; Headaches; Body aches; Chest pain; Didn't had wishes to eat; Diarrhea; COVID-19 pneumonia; A spontaneous report was received from a consumer concerning a 69-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced COVID-19 pneumonia, feeling unwell, headaches, body aches, chest pain, decreased appetite and diarrhea  The patient's medical history high blood pressure which was controlled with medication. Concomitant product use included nifedipine and fenofibrate.  On 20-JAN-2021, approximately a week and a half or two prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 030L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  A week and a half or two later the patient stated feeling unwell, headaches, body aches, chest pain, decreased appetite and diarrhea for which patient was hospitalized on 06-FEB-2021. Since everything seemed to be fine the patient was discharged on an unknown date in FEB-2021 however, patient's family was not notified that it was a late reaction to the vaccine's first dose. Later, due to shortness of breath he was hospitalized again on 08-FEB-2021 and was diagnosed for pneumonia and was intubated on the same day. Due to COVID-19 situation patient's family could not be in the facilities and that there wasn't any follow up of the patient given to the family, so family did not have much information.  During the first hospitalization(06-FEB-2021) the patient had a blood test which showed a normal result and was tested for COVID-19 and Influenza, both were negative. During second hospitalization (08-FEB-2021) the hospital said that the patient was stable. The patient's family did not know the results of the tests conducted at the time.   The action taken with the vaccine in response to the events is not applicable.  The outcome of COVID-19 pneumonia was fatal. The patient died on 14 Feb 2021  The cause of death was reported as COVID-19 related pneumonia. The autopsy was not done.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  The cause of death was reported as COVID-19 related pneumonia. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the events are assessed as unlikely related. Further information has been requested.; Reported Cause(s) of Death: COVID-19 pneumonia
Several hours after taking my second dose of the COVID Pfizer vaccine, I began to experience a stabbing sensation in my toes and right knee. Since that day, the stabbing sensation has spread to other parts of my body including fingers, foot, hands, arms. I feel the pain several times a day in different regions. The pain lasts for several seconds to minutes. The symptoms seem to be increasing daily and the affected areas are growing. I have an appointment scheduled with my primary care physician, Dr. to discuss symptoms and treatment options.
Only causing left knee pain: tightness on both sides of the knee and connecting areas such as the lower thigh closest to knee area and upper leg closest to knee area. Very unpleasant pain if placing weight/pressure onto the knee. Very unpleasant pain walking for a period of time. Very unpleasant pain elevating leg in order to go upstairs or heading downstairs. I've taken Pain Reliever, Muscle Rub and place a Tens unit and at first it brought relief, but after some time though it seems to worsen and intensive tightness around the knee and on the sides.
get swollen by my collar bone the whole top of my shoulder then noticed a ball inside; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0162) via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not take any medications within two weeks of vaccination. The patient had no known allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8730) via an unspecified route of administration in the left arm on 23Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. 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 04Apr2021, at 07:00 the patient started to get swollen by collar bone the whole top of shoulder then noticed a ball inside as well. Therapeutic measures were not taken as a result of the adverse event gets swollen by my collar bone the whole top of my shoulder then noticed a ball inside. The clinical outcome of the event started to get swollen by collar bone the whole top of shoulder then noticed a ball inside as well was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Hives just below the site about the size a dollar bill. Onset approximately 1 hr post injection. Pt took a 24 hour CLARITIN (own supply) and rash resolved. Advised discussing reaction with MD to get reaction documented. Advised continue CLARITIN if rash persists. Pt to follow up with MD as needed.
Approximately seven months post second vax, this 28-year-old pt experienced hepatitis A symptoms including jaundice, swelling of the liver, fever, chills, nausea, fatigue, and tenderness. This report is considered medically serious. The information received on 05/18/2000 reported the symptoms were ongoing.
Case number PHEH2014US021043, is a combined initial and follow-up spontaneous report from a health care professional received on 15 Oct 2014 and 20 Oct 2014. This report refers to a 12 year old male patient. His medical history and concomitant medications were not reported. He received an intramuscular dose of MENVEO, batch number: X14031) that was reconstituted improperly on 07 Oct 2014. It was reported that the nurse mixed the Men A with sterile water and then mixed the Men CYW-135 conjugate component with the Men A and water vial (inappropriate preparation of medication). The nurse administered two injections of this into the patient as two 0.5 ml dose (drug administration error). No adverse event was reported. No further information was provided.
Red raised swelling of the skin, taken to ER said it was a mild reaction on 3/10/2016 he had a full blown rash head to toe which Dr.s finally call in erythema multiforme diagnosed 3/13/16 after 4 different Dr.s.
On March 13 Th, 2021 I woke up  at night with intense pain in my knees and my right upper arm near the shoulder. Ever since then the pains have gotten worse. For a few hours I will not feel any pain in my knees. The right upper arm constantly hurts when I have to lift something or type. I am not able to move it towards my back without pain. My left upper arm has also started hurting. Sometimes my wrist joints hurt, and my finger joints hurt. Once even my right foot hurt. My pains are worse at night. These aches have no pattern. They come and go all through the day but more intense at night.  I was tested for rheumatoid arthritis and the test was negative. I have had Covid test and that was negative. I am on no medications and have always been in good health. I would like to know if any other recipients of Moderna vaccine have experienced any of these symptoms. And if so are there any treatments suggested for these problem?
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 22-APR-2016 the patient was vaccinated with an improperly stored dose of MMR II (lot#I023386, expiration date 25-JUN-2017, dose and route unknown) and an improperly stored dose of (Oka/Merck) VARIVAX (lot# reported as I04688, expiration date 23-NOV-2017, dose and route unknown). The temperature and time frame were at 14.9 Celsius degree for 280 hours. There was no out of range before. No adverse events were reported. Lot number I04688 is an invalid lot number for (Oka/Merck) VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning a female who was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL. A consumer reported that her step daughter has experienced headaches, that have been pretty intense, since her third dose of GARDASIL. He also stated there was an interruption in her menstrual cycle. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. No additional AE information was reported. Additional information has been requested.