chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 28 September 2011 via a search of the scientific literature. This article describes 5 children who presented for epilepsy care with presumed parental diagnosis of alleged vaccine encephalopathy caused by pertussis vaccinations in infancy. Their conditions were all rediagnosed years later, with the support of genetic testing, as Dravet syndrome (a rare epileptic encephalopathy characterized by an onset in infancy with polymorphous seizure types and developmental decline). All five children had normal development initially. The authors concluded that vaccination acted as a trigger for seizures in these patients who already had a genetic susceptibility to epileptic seizures. They found no evidence that the outcomes, in terms of subsequent seizure types or intellect, were any different between those patients with Dravet syndrome whose symptoms started within two days of vaccination and those whose symptom onset was not related temporally to vaccination. This case captures information for one of the five patients. The other four patients have been captured in case numbers 2011-09597, -09598, -09599, and -09600. A 7-month-old male patient received Dtap (manufacturer unknown, lot number, route site and date of administration not reported) and within hours after vaccination, he became febrile and had a generalized seizure. Over the next several months, he continued to have frequent myoclonic, partial and prolonged convulsions with almost any febrile illness, including three episodes of febrile status epilepticus. Afebrile seizures and subsequent developmental stagnation with autistic like features was noted by two years of age. Previous brain MRI results were normal. An electroencephalogram at diagnosis revealed both focal and generalized epileptiform discharges. Neuronal sodium channel (alpha) 1 subunit (SCN1A) genetic test results were positive for G529A, Bly177Arg mutation, and were proved de novo through parental testing which supported a diagnosis of Dravet syndrome. The patient was 14 years of age at the time of diagnosis. Outcome was not recovered. Documents held by sender: None.
I contracted COVID-19 on 4/12/2022 with symptoms of sore throat, congestion, runny nose, myalgia, low grade temp, diarrhea, headache, fatigue, and cough. My symptoms began improving on 4/16/2022, but I had cough and congestion until 4/22/2022. I am still experiencing an occasional cough.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates the unspecified patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L001325, expiry date 13-JAN-2017) (dosage, strength and route were not reported). There were totally 10 patients administered with 2 incorrectly stored vaccine and the exact number of patients of (Oka/Merck) VARIVAX was unknown. At the time of the report, no adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient with no previously documented medical history received first dose of vaccine on 5/3/21. On 5/5, presented to urgent care clinic and was transferred to hospital with confusion, and new facial droop. Diagnosed with acute ischemic stroke, and new diagnosed hypertension and diabetes mellitus. Unknown if vaccine was the only known cause of her hospitalization, and health outcomes.
Irregular menstrual periods following vaccine administration. Increased frequency of menstrual periods (having a period every 14 days). Increased severity of menstrual bleeding and cramping.
Pt w/ hard, red bump warm to the touch. BENADRYL, MOTRIN, cool compresses.
EXTREME FLU LIKE SYMPTOMS (FEVER); SHAKINESS; NAUSEA; INSOMNIA; FEELING BAD; This spontaneous report received from a patient concerned a 25 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, treatment medications included: paracetamol. On 26-AUG-2021, the patient experienced insomnia. On 26-AUG-2021, the patient experienced feeling bad. On 27-AUG-2021, the patient experienced extreme flu like symptoms (fever). On 27-AUG-2021, the patient experienced shakiness. On 27-AUG-2021, the patient experienced nausea. Laboratory data included: Body temperature (NR: not provided) 101 F, up to 102 F, and Respiratory rate (NR: not provided) between 14-18. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme flu like symptoms (fever), and shakiness, and the outcome of nausea, insomnia and feeling bad was not reported. This report was non-serious.
When sitting in chair during observation patient passed out. Syncopal episode. EMS was activated and patient taken to hospital for further evaluation.
The doctor described the large swelling in my arm pit as edema.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 24Jun2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, shingles, lymes, menopause and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received sulfur (MANUFACTURER UNKNOWN), erenumab (AIMOVIG) and galcanezumab (EMGALITY) on unknown dates for unknown indications and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Jun2021 at 18:00, the patient experienced large swelling in arm pit described as edema by the doctor, which took over 2 weeks to go down. The patient reported that it was the size of a B cup bra. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large swelling in arm pit described as edema by the doctor, which took over 2 weeks to go down was resolved on an unknown date in Jul2021.
Fever, range 100.0°F - 102.3°F, lasting 46 hours. Including chills, mild nausea, dehydration, muscle aches, insomnia
Narrative: On 1/11/21, patient received Moderna COVID vaccine #1 and on 2/8/21, she received dose #2. No notes record any adverse events to vaccine. There is a scanned document from 2/24/21 where patient agreed to home hospice care. Date of death is recorded as 3/1/21. No documentation of any events from time of vaccines to date of death. No autopsy results reported. 21 days from date of vaccine #2 and date of death.
Patient reported redness, swelling, pain in left arm to pharmacist on duty the evening of 9/24/09. She was vaccinated with PNEUMOVAX in that arm. Pharmacist on duty advised cold compresses, BENADRYL. On 9/25/09 patient reported continuing pain, swelling, redness and fever in arm. She said she would watch it over the weekend and follow up with her MD if not better.
Pt became extremely irritable, inconsolable for greater than 3hrs; Went to ER @ 930PM, treated for ear infect;
Third Pfizer COVID vaccine received 09/27/2021. On 03/17/2022, respiratory flu symptoms and positive COVID antigen test. I first had symptoms 03/16/2022 night, tested positive morning of 03/17/2022 (Day 0), had modest respiratory flu-like symptoms 4 days through 03/20/22 evening when I felt much better, had less than 99.7°F fever until 03/19/22, had normal fever afterward, had improving flu-like symptoms, and isolated 5 days then masked through Day 10.  I never had trouble breathing. I experienced congestion, sore throat, mild fever, chills, cough, and phlegm. I contacted primary care physician via internet gateway, did not visit doctor nor hospital, stayed home.  I took Paxlovid 5 days 03/18/22 thru 03/22/22.
20 minutes post vax the pt experienced a flushing sensation on her chest and nostrils. The most recent information received, reports the condition of the pt is resolved.
When giving vaccine to patient, the needle detached from capsule syringe. The vaccine dripped out of the syringe and full dose did not go in patient. Most of the liquid dripped out.  No adverse reaction occurred. When calling Moderna customer care on 5/26/21, I was advised to give a dose again in opposite  arm. I spoke to  the patient on 5/26/21 and 5/27/21. She has yet come back to  the pharmacy to get her dose again. I will follow up again  with her through out  the week
Bone Aches; headache; Muscle Aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration in the left arm, on 07Mar2021 14:30 (at 02:30 PM) (Lot number: EN6205), at the age of 52-years-old, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took ondansetron (ZOFRAN) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19. On 10Mar2021 12:00 PM, the patient experienced muscle aches, bone aches, chills, headache, and fatigue. The patient did not received any treatment for the events. The clinical outcome of muscle aches, bone aches, chills, headache, fatigue were recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up is being submitted to amend previously reported information: in corresponding data fields, patient age was added, stop date of BNT162B2 was populated as 07Mar2021 14:30, reporter details (first and last name and email address) were updated, past drug Zofran was coded appropriately and suspect vaccine BNT162B2 was recoded as a company product.
Patient received a more concentrated dose of the Pfizer Vaccine. The error occurred by not adding enough diluent. 0.8ml of diluent was mixed in with the Pfizer vaccine instead of 1.8ml of diluent .
pt recvd 2nd dose of vax & devel burning sensation upon inject as well as soreness & or an aching sensation in the arm; sensation persisted assoc w/a feeling of heaviness in the arm x 24 hrs; pt denied any fever, local swelling or erythema
pt recv vax 23SEP97 & 4NOV97 pt had a positive cult for bordetella pertussis as determined by direct flourescent antibody testing;pt was not hosp;
Pt in with reaction to pneumo-vac.  Some redness and slight swelling around and below injection site.  Pt states it is better than yesterday, arm is less painful and swelling greatly reduced.  Pt had reaction to this vaccine and will not take again.  Told him he does not need another one in his lifetime.
As soon as shot was given I bled badly. They used about 6 square gauze to control the bleeding. The injection was not put into left arm muscle like it was supposed to. Instead it was put into the back of my left arm. I'm not sure it hit my artery or what happened. But now I still have a huge deep purple bruise, and my shoulder hurts and burns and so does my arm around the injection site.  I have been taking pictures to document bruising since date of injection.
Dad called on 8-28-07 to report that child had temperature of 101.2, fussy and had swelling in feet and hands, and red and white spots on extremities. Admitted to local Hospital for 2 days with additional swelling and fever.  Unable to find cause of swelling.  Has had vaccines since, with no problems. 7/23/08-records received for DOS 8/28-9/1/07-DC DX:Fever. Rash. Presented day of admission with hand and feet swelling and macular rash on arms, maximum temperature 100.3, decreased p.o. intake. PE:polycyclic erythematous raised lesions on upper and lower extremities bilaterally, some central cyanosis on feet. Lesions blanchable. Erythematous macules on cheeks bilateraly, hands and feet swollen.
Red; swollen; itchy; warm bump; resulted in longer bleeding; Induced my period and resulted in longer bleeding; delayed hypersensitivity reaction in left arm a week after vaccination; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13Mar2021 (at the age of 31-Years-old) (Batch/Lot Number: EN6062) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included hypothyroidism, PCOS and allergies to Shellfish. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and multivitamin. On 14Mar2021, the patient experienced induced my period and resulted in longer bleeding, red, swollen, itchy, warm bump, resulted in longer bleeding. On an unknown date in Mar2021, patient experienced delayed hypersensitivity reaction in left arm a week after vaccination. Event resulted in physician office visit. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not receive other vaccine in four weeks. Patient received Prednisone, Benadryl, and Dilation and Curation was the treatment received for the events. Therapeutic measures were taken as a result of events. At the time of this report, the outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
On 2/4/21, at around 3:00pm he began feeling very tired and he began burping in the evening.  The following morning, he woke up early and was still burping and not feeling well.  At around 5:00am, he collapsed.  My mother called 9-1-1 and began giving CPR.  The parademics arrived and tried to revive him, and transported him to the hospital but at 6:11am, he was pronounced dead of a heart attack.  He was healthy.
Pt presented to ED On 5/4/21 following vaccine w/ CC of allergic reaction following vaccination for COVID-19. Patient is now complaining of worsening severe shortness of breath, rash, cough, wheezing despite using her EpiPen. She took prophylactic oral steroids pre and post vaccination along with oral antihistamines. Pt continued to have refractory reaction despite EpiPen inhaler, antihistamines, and steroids, refractory reaction. Required repeat dose of EpiPen, bronchodilators, IV Benadryl. patient eventually discharged home from ED.
Patient was given her first covid 19 shot of pfizer.  She was told to sit for 15 minutes after the shot which she did. After her 15 minutes of post shot she stood up not feeling well and fell to the floor feeling dizzy and fainting. She rested on the floor for a few minutes then in a chair for at least an hour until somebody could take her home.
A week after injection, patient had red spot appear in the area and complained of pain in the muscle up to joint. Patient came to pharmacy today to report and states now pain is only where spot is. Has been present for 3 weeks. Referred to doctor. Patient also states it had scabbed over and had been scratching it.
Patient reports extreme pain in left arm from deltoid down to hand 2 or 3 times the pain resonated to the pectoral area. At 6pm the patient reported that the pain was beginning to lessen in intensity.
approx 3yrs p/vax pt exp chickenpox like rash. addl info requested
Moderna on 3/10 and 3/31. Positive on 8/13 admitted 8/9-current
I started feeling nauseous eating and then I'll wake up in the morning feeling even more nauseous. It was in between 1-2 weeks after 2nd shot but I thought it was just my stomach because they took my rectum out but then it got so worse I just couldn't eat anything. When I went to the ER the Doctor thought I had a UTI. The antibiotics they gave me helped for a little bit but the nausea is still there but not as back. Mostly I throw up liquid. The Doctor put me on colase and it's better but I still wake up and throw up liquid. My primary Doctor said he thinks it's constipation from the Percocet.
Pain in Rt arm. Up to neck down to thumb Redness-6 inch area swelling at site 6 inch she says arm is still difficult to use after 6 hrs. ER if Resp. distress develops.  Advised Benadryl 25mg PO q 6 hrs prn - massage area
This spontaneous report was received from a pharmacist and refers to a 28 year old female patient with no drug reactions or allergies. The patient had no pertinent medical history. On 07-AUG-2015, the patient was vaccinated with a dose of VARIVAX (Merck), subcutaneously, lot # K016127, expiration date 23-SEP-2016 (dose and frequency were not provided). The patient took no concomitant medication. On 12-AUG-2015, the patient developed a "rash on both of her feet". The patient did not receive the treatment for the event. On 14-AUG-2015, the patient recovered from the event. No lab diagnostics studies were performed. The patient sought medical attention via seeing the pharmacist. The relatedness between the event and VARIVAX (Merck) was not reported. Additional information has been requested.
prostate removal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PROSTATIC OPERATION (prostate removal) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No reported medical history.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PROSTATIC OPERATION (prostate removal) (seriousness criterion hospitalization). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to PROSTATIC OPERATION. On 21-Mar-2021, PROSTATIC OPERATION (prostate removal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication of the patient was not reported. No concomitant medication of the patient was provided. Based on the current available information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.
A non-serious spontaneous report of "eight year old received first dose of H1N1 03 Dec 2009 and second dose was administered on 23 Dec 2009" was received from a registered nurse/health care professional concerning an eight-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 03-Dec-2009, the patient received first dose of H1N1, Intranasal. After 20 days, on 23-Dec-2009, the patient received second dose. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Information has been received from a consumer concerning her son who last week, in May 2011, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not reported) and within a week, developed a non itchy rash at the injection site. The consumer reported that the rash was gone and her son had recovered (date unspecified). It was unspecified if the consumer son sought medical attention. Additional information has been requested.
Fever. Body aches. Fatigue. dizziness. Large lump in armpit. Sore arm ,Bells Palsy.
pt recv vax 26JUL96 & w/in less than 3wk on 14AUG96 exp a status sz lasting 3 1/2hr;taken by amb to local ER & was airlifted p/several hr to hosp;10wk later had another status sz;pt exp 30 small sz as well as 3 prolonged status sz;
red circle around the injecting site; injecting site, itchy; injecting site; a hard ball underneath; This is a spontaneous report from a contactable other healthcare professional (patient). A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number El3246 and expiry date unknown) via unspecified route of administration at the left arm on 13Jan2021 09:15 at single dose for Covid-19 immunization in a hospital. Medical history included liver tumors, and allergies to "sulfer", thyroid (disorder), anxiety and blood pressure (abnormal). Concomitant medications included thyroid, anxiety and blood pressure medications. The patient has no other vaccine in four weeks. On 14Jan2021, the patient experienced red circle around the injecting site, itchy and a hard ball underneath. The patient did not receive treatment due to the events. The outcome of the events red circle around the injecting site, itchy and a hard ball underneath was not recovered.
I started feeling a warm sensation come over me and  then I got hot. Then I noticed the hives (rash)  starting on my stomach region. They were on my arms or legs by that evening. I felt flush, headache, slight red throat, tired and of course muscle pain at the injection site only. I almost always get these hives during a viral infection, cold cough, strep  throat. I did not have a cough, cold or sore throat. I did notice hot coffee hurt my throat a little that morning as I had a little sinus drainage due to weather here, rainy and cold.  I am breathing just fine. The next morning the rash had spread over my body as just red without a lot of small bumps. By the next day, Friday the 21 everything was gone and I had no other illness, No sore throat just the slight headache. I get this exact rash when my body is fighting an illness or virus. I called my doctor on the 19 and he thought it was caused by a virus and advised me to go to emergency if I had any breathing problems. I thought I should report as I saw on the web that an infant also got several shots and 24 hours later had the same hives as I did. I am wondering if it is something in the shots that I reacted too.
Around a week after getting the booster of Covid 19, I began getting a headache on the left side of my head with intermittent stabbing pain.   The pain only lasted a few seconds but I always feel mild pressure to the left side of my head.   The headaches would only be a 2-3 times a day but then became more frequent.  I looked up my symptoms and found a clear description of them known as Ice Pick headaches.  Taking Tylenol didn't help relieve them so I went to see my doctor.  I am still getting the headaches and as of yesterday, they are beginning to happen on the right side of my head as well.
Patient called the pharmacy the next day and complained of more pain then he was expecting in his arm. The patient also stated he felt the dose was given too close to his shoulder.
I woke up about a month after my first Pfizer dose with a very swollen left wrist on the radial side. It felt as if I severely injured my wrist. I could not move my wrist at all at that time. I iced my wrist and wore a brace for a couple months. The swelling went away but to this day I can still not move my wrist in certain motions. There was nothing I did to cause that type of injury and in addition I am right handed not left. I got an xray  on 4/6/21 that showed no break or fracture. However I have not had an MRI done due to cost. I know there is some type of damage because my wrist still hurts when I do certain motions.