chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/7/2022- Assitant to the family calling for acute constant severe fever (101.5 currently), headache and intermittent seizures "every night" since pt received immunizations (TDAP, Polio, Covid-19, Hep A and HPV) at Health Dept on 7/29. Per pt's father pt "feeling cold and shaky". Pt is awake and alert per pt's father. Pt has hx of seizures but from symptoms reported by pt's family the number of seizures pt has been having has increased since pt received the 5 immunizations. PT reached out to pt's neurologist on 8/5 r/t reported seizures and neurologist recommended increasing pt's Keppra medication to 750 mg BID per note in pt's chart. Per note in pt's chart neurologist staff were not able to reach pt's family to inform them of the increase in medication dosage. Pt's family denies receiving message regarding increasing pt's Keppra medication dose.   Symptoms started 7/29.   Pertinent negatives include: No chest pain. No breathing difficulty. No cyanosis. No diarrhea. No vomiting. No cough. No known exposure to Covid-19. No symptoms of dehydration, still urinating with normal frequency.  Patient unknown.   Patient presented to Hospital on 8/7/22 and is currently admitted (as of 8/10/22) for;  Hospital Problem List   Epilepsy, unspecified, not intractable, without status epilepticus  Left lower lobe pneumonia  Sepsis due to pneumonia  Fever in pediatric patient   Hyponatremia   Leukocytosis   Hypotension   Bacteremia due to Gram-positive bacteria
Sweaty; Hot; Tired; Sore arm; Fever that peaked on 101 F; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweaty), FEELING HOT (Hot), CHILLS (Chills) and PYREXIA (Fever that peaked on 101 F) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, SIMVASTATIN, CALCIUM, FISH OIL, CICLOSPORIN (RESTASIS) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills). On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever that peaked on 101 F) and HEADACHE (Headache). On 17-Mar-2021, the patient experienced FATIGUE (Tired). On 18-Mar-2021, the patient experienced HYPERHIDROSIS (Sweaty) and FEELING HOT (Hot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 16-Mar-2021, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever that peaked on 101 F) and HEADACHE (Headache) had resolved. On 17-Mar-2021, FATIGUE (Tired) had resolved. On 18-Mar-2021, HYPERHIDROSIS (Sweaty) and FEELING HOT (Hot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Body temperature: 101f (High) 101 F.         Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-051515 (Patient Link).
HEARING LOSS/CAN NOT HEAR VERY WELL; DIZZINESS; TOSSING IN EAR / PULSING IN EAR; MAKE IT VERY HARD TO DO THINGS; TINNITUS; This spontaneous report received from a consumer concerned a 27 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: unknown) dose was not reported,1 total, administered on 11-APR-2021 to right arm as prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in JUL-2021, the patient started experiencing hearing loss/could not hear very well, and also got worse, dizziness, tossing in ear/pulsing in ear and tinnitus. The reporter further stated that the symptom was patient experienced not for all days but mostly when the patient woke up. It was very hard for him to do things. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus, dizziness, hearing loss/can not hear very well, tossing in ear/pulsing in ear, make it very hard to do things. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210835348.; Sender's Comments: V0:20210835136-Covid-19 vaccine ad26.cov2.s-Hearing loss/could not hear very well. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Redness, irritation, swelling, inflammation at injection area and down arm appearing day following injections. Patient in today (3rd day after) saying redness is improving but wanted to consult about effects. Advised patient to take oral antihistamine and use topical steroid cream. Also ibuprofen if pain/swelling is present. Advised to monitor area and consult dr if symptoms worsen or do not begin to improve in next few days.
99-101 fever, headache, joint pain for all of the next day following vaccine. Two days following vaccine my arm pit of the arm I received the shot is hurting and swollen.
Bell's Palsy diagnosis: can't move my right face muscles. Treatment: Prednisone (for 10 days) and Valtrex (for 7 days)
Day 1-3 = sore arm; Day 2-4 = tired Narrative:
Slight swelling of tongue, throat-days 1 and 2 , tingling and numbness in face intermittently for almost 2 weeks , headaches, dizziness  Completely normal on 1/22/21
As related by parent, Pt.'s R arm and shoulder at injection site became very swollen, child taken to ER. Parents thought needle was in arm. Arm X rayed. No needle in it. Child was placed on KEFLEX TID. " For something about cells" stated the father.
A territory representative reported that a pt inadvertently received 0.4 ml of Prevnar instead of the recommended dose of 0.5 ml. A few days, post vax, the pt developed an ear infection. No further information was available at the date of this report. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Developed acute local reaction with rash approx 15x10 cm in area of injection site. Extremely uncomfortable and painful. This is from PREVNAR.
Fatigue; Low grade fever; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration at right arm on 20Mar2021 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's disease and asthma. The patient did not have allergies to medications, food, or other products. Concomitant medications included Synthroid, vitamin D (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and cannabidiol (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 15:00, the patient experienced fatigue, low grade fever and arm pain. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events fatigue, low grade fever and arm pain were resolving.   Information about lot number cannot be obtained. No further information is expected.
With shot one, I had a pain behind my left ear, felt like someone hit me in the head with a hammer, has had pain swelling and redness 08/12/2021, then tenderness, swelling, redness since 08/25/2021. My period came on day 19 of my cycle, 5 days after shot on 8/16/2021. And was only 5 days vs 7. Last night I could feel my heart racing even though I was sitting for over 20 mins. I took my pulse with an automatic blood pressure cuff, b/p was 105/73, pulse was 94. Took one benadryl and two ibuprofen due to arm pain and swelling. Took pulse again before bed and it was still at 93. Woke up at 07:15 with a fever 100.2f and my pulse was still at 91. My normal resting pulse is 68-75. It feels like I just ran a set of stairs even though I'm sitting on the couch.
All symptoms started the morning after receiving the shot and lasted three days. I had joint aches in my fingers that lasted almost two months.   Symptoms lasting three days include: Extreme fatigue, severe headache, joint ache throughout body, Extreme sweating (was as if I just stepped out of the shower), Fever, Random sharp pains as if being pinched that would occur every 20-30 minutes and last about 15 seconds per episode, pressure behind both knees.   I was in the emergency room in April 2021 with Covid and this first shot made me feel as bad as I did then.
pruritic rash on face and chest, seen in ER & rx w/Seldane
Fever, rapid heart rate, and flu like symptoms within 6 hours of receiving vaccine. Extreme abdominal pain coupled with fever began again in the night of 01/26-01/28/2021. Extreme abdominal pain continued and I had to have emergency appendectomy on 01/30/2021.
On the day after the Flumist, patient had 5 hours of vomiting every hour.
1st dose 2/19 - some left arm pain, difficulty sleeping on the left side; 2nd dose 3/19 - fever (up to 100.5)and chills, stomach pain, nausea, felt miserable for approximately 30 hours. Got better, since them, ever so often, fatigue, some pain, nothing out of ordinary; on 4/2 (3 weeks after 2nd dose), woke up in the middle of the night, with palpitations, dizziness, nausea, chills. Called 911 thought was having a heart attack. Labs at ER were fine. I still feel lots of fatigue and chills (no fever). Per ER not an MI or Stroke, maybe a panic attack. Never had anything like that, still feel nauseated, lack of appetite and chills. Difficulty sleeping since the first dose.
Patient has been experiencing insomnia, fatigue, and musculoskeletal pain x5 weeks, beginning 3 days post vaccination.  Had a robust take.  Erythema still present around site.  Site has reacted. Follow up 1/14/04: Patient contacted to inquire regarding the current status of the symptoms that appeared 5 to 7 days after receiving his vaccination. He reports that he continues to experience fatigue, body aches, malaise, and difficulty falling asleep. He also indicated that although the symptoms have improved over the last few months, he still does not perceive that he has returned to his pre-vaccination health status. He continues to be employed full time in his job. The fatigue and malaise have, however, decreased his participation in activities outside the workplace.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case is linked to cases 2018SA279965, 2018SA279966, 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281637, 2018SA281634, 2018SA281636, 2018SA279979, 2018SA281687, 2018SA281692 (Same reporter). This case involves a 15-months old female patient who received a 0.5 mL dose of PENTACEL (lot number: C5507AA and expiry date: 05-Sep-2019) (dose in series and route was not reported) in the left thigh on 12-Sep-2018 which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that patient was given vaccine after temperature was at 30 F for 4 hours: below freezing. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Approximately 1 hour after vaccination, abdominal pain and extreme diarrhea started.  Heartbeat became irregular with racing/pounding feeling. Flushing started. Went to bed early due to feeling sick. Anxiety/feeling of impeding doom/tragedy. Rash beginning on torso. Woke up at approximately 1am with running nose, sore throat, flushing/sweating, feverish, extreme abdominal  pain, headache, extreme dizziness, shortness of breath, back pain. Almost passed out when standing and had to crawl. Couldn?t stand without feeling faint/lightheaded.  Red, itchy, burning rash/hives on torso, arms, legs.
Swelling of both eyelids and lips.  Symptoms relieved by 50 mg benadryl po.
"Pfizer-BioNTech COVID-19 Vaccine EUA"  May 1, 2021 at 10:30 am: Received 1st vaccination (left deltoid)  May 3, 2021 at 1:30 pm: Sudden onset left ear tinnitus, frontal headache, vertigo, and nausea. Approximately 15 minutes later, had two (2) episodes of emesis. All symptoms (except headache) resolved at 6:30 pm. Headache ultimately resolved at 8:30 pm. Did not take any medication.
Pt started complaining of neck pain the night of the day vaccine was given. I doesn't hurt to touch chin to chest but it hurts to bend his head backwards. Pt did not sleep well after vaccine either.
The patient reported severe pain in the arm of injection that started between 1-2 hours post vaccination. The following day he noticed floaters in his vision. He made an appointment with a regular eye dr (4/4/21) who referred him to a Retina specialist At the appointment with the retina specialist they noticed holes in the patients retina. They dr had to preform freezing and gas treatment to prevent the retina from detaching. The doctor wants the patient to recheck in 3 months.
Patient was newly pregnant at time of vaccination. After about 2 weeks of receiving the first Moderna vaccine, patient had a miscarriage. Patient would have been between 4 to 8 weeks pregnant at time of miscarriage.
One day post vax pt developed hive patches dime to quarter size, raised whelps. Hives began on left abdomen area and spread around abdomen to upper back, then behind both knees. Pt called clinic and was advised to use cortisone cream on areas and take to ER if conditioned worsened. Pt had no fever or itching. Areas would fade away and then reappear if pt got hot or perspired. No further problems. As of three days post vax pt only has a few whelps on mid abdomen.
Patient felt dizzy after vaccine and had a metallic taste in mouth. Her vitals were normal. No signs of allergic reaction. Patient said dizziness passed quickly. She declined treatment and felt fine enough to leave.
Pt vaccinated with Pneumovax 23 within 3 hrs of injection, pt c/o painful red arm which was somewhat swollen & hot to touch. Developed a cellulitis of the rt arm, lymphangitis 7 swollen glands. Treated w/Cefadroxil.
Dizziness, NauseaVomiting, right arm mild soreness Narrative:  12/29 employee reports onset of dizziness and nausea about 2 hours after the vaccine. Her right arm is slightly sore. 12/30 - symptoms have improved and are very slight today. 12/21 resolution of all symptoms.
Pt. developed swollen glands and tongue within 20-30 mins of admin. Pt taken to ER - received BENADRYL & cortisone.
Pain at approximate injection site when arm is moved in certain normal positions which subsides temporarily when the arm is forced through the discomfort. Pain and stiffness in the night. Other than certain movements (e.g. reaching for the toilet paper or hanging up clothes or exercising and inertia at night, there is no pain. Up to now my life has luckily  been pain free, but since the injection there's a little "sympathetic" twinge in the knee on the same side and the other arm, but I don't see how this can be related.
Slight fever (99.3°), chills, moderate body aches, and severe headache. All onset 8 hours after vaccination and lasting for 24 hours.
Coughing, fever, chills, sweating,  lethargy, decreased appetite, SEVERE nose bleeds lasting 20+ minutes, increased blood pressure and heart rate.   Induced an asthmatic flare which required increased breathing treatments, steroids, and antibiotics.   **Maternal grandmother had  severe reaction. VAERS NUMBER 1182545
pt recv vax;4-5 days later exp HA&lt shoulder pain;er visit required
Fatigue; sore arm; stiffness through out day; difficulty walking due to pain; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old male patient received BNT162B2(BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, sore arm, stiffness through out day, difficulty walking due to pain. The outcome of the events were unknown.  No follow-up attempts are possible. Information about batch/Lot number can not be obtained.
nerve discomfort in my left foot; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (nerve discomfort in my left foot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 NEURALGIA (nerve discomfort in my left foot). At the time of the report, NEURALGIA (nerve discomfort in my left foot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
She developed pericarditis/myocarditis and was diagnosed 4 days after receiving second dose of Covid19 Moderna vaccine
Temp 102 degrees orally, P. 140-continued for 2 weeks (normal temp 96-97 degrees). Now fever free for 10 days-pulse rate around 104-wants to refuse further vaccinations of Hib, IPV, HBV, Td & MMR/VZV.
Mouth sores on the back of throat.  Looks like a big canker sore.  One started a few days after and next a few days after that.
Rt thigh, red swollen, c/o itchy Benadryl 1tsp PRN Topical Benadryl to affected area.
13 x 13 cm erythema, warm area of non-tenderness at left upper an thigh.
I have been experiencing a small ulcerative colitis ?flare up? which I have not had in a while. I have experienced slight stomach pain and slight bleeding.
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium
ADMITTED W/ SORE THROAD, CHEST CONGESTION/PAIN, DRY COUGH, FEVERS, BODY ACHES, URI SYMPTOMS, SOB, GENERALIZED WEAKNESS FOR 3 DAYS PTA.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. No follow-up attempts are possible. No further information is expected.  Additional information: The patient was not  taking any other medications/products within 2 weeks of starting COVID-19 treatment.The patient previously receive a COVID-19 Vaccine.
I took shingle vaccine first dose on 08/2018 and second dose on 11/2018. I am developing a very strong throat pain, discomfort on my body, jaw pain. It bothers me because I am feeling so sick.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, 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 SHINGRIX. Additional details reported as follows: This case was reported by the pharmacist on behalf of the another health care provider. The age at vaccination was not reported. In 2018, the patient received a dose of SHINGRIX. At the time of reporting, the patient came back for 2nd dose of SHINGRIX, but the patient had case of shingles. The reporter did not have any additional information.
Severe swelling and pain at injection site. 24 hours after injection I had fatigue and fever 100.4
Aching muscles and joints, shivering, slight headache, extreme fatigue, soreness at injection site but that much was expected. Took Ibuprofen, 400-600 mgs per dose, sleep. Symptoms started Sat night(injection day), it's now Monday. Most symptoms have subsided. Still some muscle soreness and fatigue. I had the same reaction after the first dose. Was hoping after the first dose my body would handle the 2nd dose ok.
Dizziness, Arthralgia, UrticariaPruritus, Pain @ injection site Narrative:
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date the multiple unspecified patients received improperly stored PNEUMOVAX 23 (lot # L019835 with expire date 23-MAR-2017) (dosage and route not reported). The conditions storage of the vaccine was: maximum temperature 47 F for 21 hours and minimum temperature 29 F for 273 hours (multiple cycles, more than 3). There was no previous temperature excursion. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
She is very sick; This is a spontaneous report from a contactable consumer. A female patient (reporter's mother) of an unspecified age (Age: 84; Unit: Unknown) received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated "we had that COVID test (unknown results), the COVID Vaccine on Sunday and my mother, I am calling for my mother and she is very sick (onset date not reported) and we don't know if we need to go to the emergency room or what." Reporter further stated, "we talked to our doctor and he said take her to the emergency room and just get her checked out. She is 84." The outcome of event was unknown.  Information about Lot and Batch has been requested.
I had a sore arm at injection site right after for 2 days, after 3 weeks I got a bad bout of vertigo that lasted about 5 minutes. Immediately after I get nauseous for a couple of hours. I'm still having small episodes of dizziness and lightheadedness.