chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Underneath both eyes were extremely swollen, it looks like two giant bubbles under my skin/both eyes they are painful to the touch; Underneath both eyes were extremely swollen, it looks like two giant bubbles under my skin/both eyes they are painful to the touch; fever; chills; The joints connecting my arms and knees were burning; Extreme fatigue, slept nearly 15 hours straight; Shaking; headache; dry mouth; severe trigemenal neuralgia flare up in my face (chin, jaw & cheeks); severe trigemenal neuralgia flare up in my face (chin, jaw & cheeks); Extreme fatigue, slept nearly 15 hours straight; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: er8732 and expiry date were not reported), via an unspecified route of administration, in Left Arm, on 19Apr2021 at 14:00 PM (age at vaccination: 33 years), as dose 2, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included ongoing trigemenal neuralgia and botox & facial fillers. Past drug included Cephlex and had allergies: Cephlex. Concomitant medications were not reported. Historical vaccine first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 20Apr2021 at 03:00, She had a severe Trigemenal Neuralgia flare up in her face (chin, jaw & cheeks). The next morning underneath both eyes were extremely swollen, it looks like two giant bubbles under her skin/both eyes they were painful to the touch. On 21Apr2021, she had a fever & chills for 10 hours. The joints connecting her arms and knees were burning. The patient had extreme fatigue and slept nearly 15 hours straight. She had shaking, head-ache & dry mouth. She had a history of botox & facial fillers. but I have not had any in over a year. The patient did not receive any treatment for the events. Outcome of the events fever and chills was recovered on 21Apr2021 and for all other events, it was not recovered.  No follow-up attempts are needed. No further information is expected.
I had the worst headache of my life on 3/22 but assumed it was a migraine and treated it as such.  On 3/23 while playing hockey, nearly immediately after starting, the headache returned even stronger than on 3/22 and forced me to stop playing as I could not concentrate or focus.  The headache lasted for several days.  The following morning I went to my standard physician who immediately sent me to the ER because he was concerned about a potential aneurysm.  No cause was ever determined as the tests were inconclusive but it was suspected to potentially be a pinched nerve.  However, I never had any pain in my neck or elsewhere besides the headache.
I typically faint when getting shots or blood drawn. I did faint about 10 seconds after the initial shot injection. I was conscious throughout but was not able to speak clearly or control my body even though I could hear everything going on around me. After 30 minutes, I was feeling back to normal. The remainder of the day I felt drowsy and a little out of it. At 12:15am I began to get severe chills and shakes. This lasted throughout the night but was the worst from about 12:15-1:00am. I woke up at 4am with a fever and sweating. My entire body was stiff and in pain with aches specifically in my arms and legs. Very sore pain in my left deltoid where the shot was injected and is still slightly sensitive. It felt like my veins were stiff and in pain and it hurt to move. I had what I can describe as flu like symptoms (i.e. my teeth hurt, my body ached, fever, shakes, body stiffness and overall tiredness and weakness). These all lasted until about 6:30am at the worst and were relieved over the next few hours. I started to feel back to normal around 3pm later that day. That was April 11th. Last night, April 12th, I had trouble sleeping because my left arm was in pain from my elbow to fingers. It was a lingering pain that went away by this morning and  is mostly gone now (morning April 13th).
Needle Hub Broke; liquid  Dripped down Arm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SYRINGE ISSUE (Needle Hub Broke) and ACCIDENTAL UNDERDOSE (liquid  Dripped down Arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. BNT162B2) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced SYRINGE ISSUE (Needle Hub Broke) and ACCIDENTAL UNDERDOSE (liquid  Dripped down Arm). On 02-Mar-2021, SYRINGE ISSUE (Needle Hub Broke) and ACCIDENTAL UNDERDOSE (liquid  Dripped down Arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatments were reported.
Nausea, weakness, pneumonia, nasal secretions, vomiting, unable to eat or drink without vomiting, increasingly unbalanced and dizzy. Hospitalization.
Headache; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself) via a Pfizer sponsored program Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced headache on an unspecified date. Patient is asking if she can take pain reliever. The outcome of event was unknown.  Information about Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Nurse). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "LV hypertrophic cardiomyopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Paxlovid day of positive home test w improving conditions waiting 24 hrs initially; Negative, notes: testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient has no known allergies. The patient was treated with Paxlovid from 29May2023 to 03Jun2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a health professional concerning a 74 year old female with no pertinent medical history who on 13JAN2004 was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. On 13JAN2004 the pt developed "swelling, itching and hot around injection site". The pt was told to put ice on the affected area. The outcome is unknown at this time. Unspecified medical attention was sought. There was no product quality complaint. No lab diagnostic studies were performed. The reporter also indicated that three other pts were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Additional info has been requested.
Chest Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   The reporter considered the rash to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got reaction from shingles vaccine.  The patient got chest rash. The patient asked if he/she was allergic to shingles vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Patient had immediate dizziness and nausea after vaccine administration at 1:00 pm.  She developed a widespread urticarial rash on chest and neck within 5 minutes of vaccine administration.  She was immediately given diphenhydramine suspension, 25 mg (10 mL of 12/5mg/5mL).  Rash resolved within 15 min of administration.  She continued to have nausea.  At 1:45pm symptoms had improved and she was cleared to go home.
tired after getting shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired after getting shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced FATIGUE (tired after getting shot). At the time of the report, FATIGUE (tired after getting shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
On 11/29/2022, I first had symptoms of body ache, runny nose sore throat and a little congestion. The fever was not very high. I was a at a dinner with 5 people having COVID-19. I contacted my doctor the next day. She got a prescription for Paxlovid. It was drastically better. I still had a runny nose. Two weeks after I got that runny nose again and tested positive. I just isolated for 10 days; I took Tylenol if I needed it. I didn't need anything really.
The pt experienced pain at the shoulder, arm and neck on the same side of injection. The pt went to the MD 9 days post vax and was then diagnosed with muscular pain. The pt was treated for pain and heat.
Redness, mild swelling and moderate itchiness at vaccine site appeared on Day 9 after vaccination.  Today is Day 10 and symptoms continue.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked to cases 2019SA071131, 2019SA071150, 2019SA071151, 2019SA071152, 2019SA071153, 2019SA071156, 2019SA071146, 2019SA071147, 2019SA071148, 2019SA071149 and 2019SA071155 (same reporter). This case involves a Pediatric patient of an unknown demographics who was accidentally administered with FLUZONE HIGH DOSE (prefilled syringes) during the 2018- 2019 Flu Season, (lot UJ043AB, expiry date 22-May-2019) via unknown route in unknown administration site instead of FLUZONE QUADRIVALENT (lot number and expiry date not reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose. No side effects had been 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. Documents held by sender: none.
SHORTLY AFTER RECEIVING VACCINE, PNT STATED SHE WAS ITCHY ALL OVER AND HER TONGUE FELT "TINGLY" ? CALLED 911 AND THEN IT PROGRESSED TO DIFFICULTY BREATHING, ADIMISTERED EPIPEN.
Tired, weak after vaccine. Took 10mg cyclobenzaprine at 930pm. Started to get uncontrontollable chills and shivers after 10pm. At 12:30 am woke up to use restroom and i could barely walk...my entire body was rigid from head to toe, almost fell down. Couldn't bend legs, ankles, hips, etc. Slept until 830am 4/15. Still stiff, but not as bad as earlier.
pt recv vax 16SEP96 & p/pt exp a fever;2OCT96 pt devel a rash @ inj site;
-Pt received COVID19 vaccine (Moderna) at MDLS on 1/8/2021 at 9:51 PM.  -Pt was observed for the recommended 15 minutes but then came back at 2:13PM with a little rash on her face and chest. -Denies headache, shortness of breath, difficulty breathing, chest pain, dizziness, numbness/tingling, N/V, rash anywhere else on her body, difficulty swallowing, itchy/sore throat, itchy/watery eyes, congestion. -Vitals were stable (see vitals). -Pt was observed for 30 min & did not have worsening of rash or other symptoms.  -Discharged after 30 min.
Twelve hours after the vaccine, I developed chills.; fever that went up to 100.4; Headache upon waking; aches; sore arm; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution .  A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 15Feb2021 09:30 (lot number: EM9810; expiry date: unknown) as dose 2, single, for Covid-19 immunisation. Medical history included intracranial hypertension with papilladema, digestive issues from removed gallbladder, and Covid-19 on an unknown date (prior vaccination). The patient had no known allergies. Concomitant medications included acetazolamide, colestipol hydrochloride, and esomeprazole magnesium  taken for unspecified indications, start and stop dates were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Jan2021 (lot number: EL1283; expiry date: unknown) at 11:15 AM in left arm for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient has not been tested for COVID-19 since vaccination. On 15Feb2021, twelve hours after the vaccine (at 21:30), the patient developed chills. Through the night she developed a fever that went up to 100.4. Headache upon waking. Chills, aches, sore arm, and fever throughout the day. Fever broke around 36 hours and then she was fine at 48 hours post vaccine. The patient did not receive treatment for the events. Outcome of the events was recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information expected.
I got the shot, later my blood pressure was higher than ever before.  On May 1st, it went to 160/92; 172/98; 159/92; 153/95; later on, on May another reading of 155/88. I called my doctor, and he increased one of my blood pressure medicines and now is back to normal.
9:50 am. Patient noted itchy throat and felt lightheaded.  No difficulty swallowing or SOB.  Immediately evaluated by onsite NP and EMS.  VS 128/90; p72. Sat 98% on RA.  R 14.  Benadryl 25 mg po administered 0952 am.  Patient remained in observation, showing no additional symptoms. Reported improvement in symptoms.  Discharged home at 10:16 am.
Mom states the patient developed a rash all over his body, a high fever controlled by Tylenol.
Onset of shingles rash; ER visit May 9, 2010; diagnosed as shingles by dermatologist May 10, 2010 and by primary care physician May 11, 2010.
Patient reported 8/10 pain at injection site hours after receiving flu and PNEUMOVAX vaccine. She self treated with TYLENOL on 4/6/17 (late evening) and came in to care on 4/7 at 2pm for evaluation. Ice pack applied, continued TYLENOL for pain.
Fever of 102.2 ,body ache, headache, tired on day 1. Fever of 100.2, body ache, headache, tired day 2. Day 3 no fever but body ache, lightheadedness, tired.
L deltoid redness 2 days after vaccine (immunization 1/17/06) pt had IPV, Dtap.
Vertigo starting within 3-4 hours after vaccine was given and persisting > 1 week no hearing loss did have preceding viral syndrome
Severe headache; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9264), via an unspecified route of administration in right arm on 02Feb2021 at 10:30 AM (at the age of 59-year-old) as a single dose for COVID-19 immunization. The patient did not receive other vaccine in four weeks. There was none known allergies. Patient did not have covid prior vaccination. The patient's medical history included type II diabetes mellitus. The patient's concomitant medication (other vaccine in two weeks) included metformin, lisinopril, jardiance, atorvastatin. On 15Feb2021 at 10:15 AM, the patient experienced severe headache. The patient did not receive any treatment for the event. The patient had not tested for covid post vaccination The outcome of the event was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected
Pt received the Covid-19 vaccine at 2035. At approximately 2045, pt. reported feeling a slight swelling of her throat in the tonsillar region. She denied shortness of breath and difficulty breathing. She reported that her throat felt numb. At 2050: P: 69, SaP02: 96%, B/P: 110/75. Rapid Response team was called. RRT arrived at 2100 and patient stated symptoms remained unchanged. Pt. Transported to ED with RRT in wheelchair.
pt following day developed red raised rash over entire chest/neck area, and psread over next few days
First couple days I had a very sore arm , pinpoint pains in the right side of my head , very vivid dreams . 2 weeks later I got a rash and mild pain at injection site . 3 weeks later I got swelled up ankles .
Headache, Rash, NauseaVomiting, INJECTION SITE PAIN/REDNESS/SWELLING ON MORNING FOLLOWING INJECTION (1/22). NAUSEA AND HEADACHE 1/21 AND 1/22. Narrative:
Day 2: dry throat, followed by severe sore throat for 2 days.  Day 5: fever for 2 - 3 days.  Day 7 : upper respiratory symptoms - nasal congestion and cough.
1 day after vaccination with Zostavax the patient developed an intense local reaction at the injection site. 10 days post-vaccination the patient developed cold sores (herpes labialis) which she has had before. 14 days post-vaccination the patient developed a typical zoster rash on the L chest starting at about T12 and radiating anteriorly to the mid-axillary line.
Information has been received from a pharmacist concerning a male who was vaccinated with VARIVAX (Oka/Merck).  The patient failed to SEROCONVERT for VARICELLA ZOSTER virus antibodies after receiving two doses of VARICELLA VIRUS vaccine live 8 weeks apart.  No adverse symptoms reported.  Additional information has been requested.
Fever or Chills  Fatigue  Muscle or body aches  Congestion or running nose  Nausea or vomiting  Diarrhea
Patient was supposed to receive second dose in the Moderna series for COVID-19 (0.5ml). Patient instead received a booster dose of Moderna (0.25ml).
This case was reported by a pharmacist via call center representative and described the occurrence of unwell in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired. On an unknown date, the outcome of the unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the unwell, generalized aching, chills, fever, influenza-like symptoms and activities of daily living impaired to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient did receive SHINGRIX some weeks before the reporting date and the patient became ill the next day of the vaccination day with generalized aches, chills, fever and heavy flu-like symptoms. These were severe enough to disabled the patient for a day but only lasted 24 to 36 hours. The reporter asked if those were the common response. It was interesting that they both (the patient's family member who received SHINGRIX refer case US2018GSK151444) reacted exactly the same. The reporter said that any information could offer here would be appreciated. The reporter said that he was recently retired hospital pharmacist so please do not hesitate to offer him provider information. He understood the pharmacology as well as the supply chain issues. This case was one of the 4 link cases, reported by the same reporter.
pt adm to PICU on 7JUL97 p/being found apneic & pulseless in crib @ home about 5:30AM;pt did not eventually survive this event;approx (?) 20hr earlier recv vax;