chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 minutes following vaccination patient experienced heat in her ears and her head, sensation that; 5 minutes following vaccination patient experienced heat in her ears and her head, sensation that; 5 minutes following vaccination patient experienced heat in her ears and her head, sensation that; soreness in the arm; 5 minutes following vaccination patient experienced heat in her ears and her head, sensation that; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), TEMPERATURE INTOLERANCE (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that), PALPITATIONS (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that), DYSPNOEA (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) and CHEST DISCOMFORT (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm) and TEMPERATURE INTOLERANCE (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that). On an unknown date, the patient experienced PALPITATIONS (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that), DYSPNOEA (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) and CHEST DISCOMFORT (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that). On 25-Mar-2021, TEMPERATURE INTOLERANCE (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in the arm), PALPITATIONS (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that), DYSPNOEA (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) and CHEST DISCOMFORT (5 minutes following vaccination patient experienced heat in her ears and her head, sensation that) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included LEVOTHYROXINE  and Antianxiety medication. Treatment information was not provided.
Information has been received from a licensed practical nurse concerning a 51 year old male physician with no pertinent medical history who on 05-NOV-2001 was vaccinated with a first dose of PNEUMOVAX 23. On 01-OCT-2007 at 11:30 the patient was vaccinated subcutaneously into the left arm with a second dose of PNEUMOVAX 23 (Lot # 657525/0554U). There was no concomitant medication. On 02-OCT-2007at 08:00 the physician developed a localized skin reaction at the injection site that was quarter size with redness and itching. There were no laboratory or diagnostic tests performed. Subsequently, the physician recovered. Additional information is not expected.
Arm very very red swelled down to his elbow, 102 fever with nausea vomited 2 days and now diarrhea.
A spontaneous, non-serious report of dizziness, lightheadedness, ear infection, sinus infection, stomach ache, fever, body aches, sore throat, congestion, headaches and malaise has been received from a patient's mother concerning an 11-year-old male patient subsequent to FLUMIST therapy. Medical history and concomitant medications were not reported. On 27-Oct-2008, the patient received FLUMIST. Since the patient received FLUMIST, he has continued to have problems. Immediately after receiving FLUMIST, the child felt dizzy an lightheaded. A couple of days later, he had a stomach ache, fever, body aches, sore throat and congestion; he also had bad headaches. The patient went to the doctor's office and was diagnosed with a sinus infection; he was ministered antibiotics (unspecified). He continued to have headaches, malaise and stomach complaints. The patient also went to see a neurologist; an MRI was normal. He continued to have ear and sinus infection with sore throat. The child was not immunocompromised. The events of sinus infection, ear infection and sore throat were ongoing. The outcome of dizziness, lightheadness, stomach ache, fever, congestion, headaches and malaise were unknown.
The patient expericence lightheadness, flushed, heart palpation, and chest tightness. Her vital are BP 119/54, 62 heart rate, O2 was 99. The patient was monitored until the symptoms went away. It all passed within 20 minutes. The patient was walked to her car by employee.
Extreme malaise, paresthesias in opposite arm of vaccine, intense body pressure sensations, weakness in limbs, heart pain, depression and anxiety
rashes near injection site; cellulitis near injection site; 2 weeks arm still sore; This non-serious case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced rash (Verbatim: rashes near injection site), cellulitis (Verbatim: cellulitis near injection site) and pain in arm (Verbatim: 2 weeks arm still sore). The outcome of the rash and cellulitis were not reported and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the rash, cellulitis and pain in arm to be related to Arexvy.   It was unknown if the company considered the rash, cellulitis and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-NOV-2023 The patient received Arexvy at pharmacy.  The doctors examined patient after complaints of rashes/cellulitis near injection site and 2 weeks arm still sore. The reporter agreed to follow up from GlaxoSmithKline. The case had been linked to US2023AMR151896, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR151896:same reporter, different patient
Elevated temp? x 8 days following vax; Pt also had edema & erythema @ inject site; MD attributed fever to rxn from vax;
Patient complains of joint pain starting in injection arm then moving to opposite shoulder and down into her hands.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Rec'd Moderna vaccine on 2/25/21, 3/24/21 and 11/26/21. Recent admit 7/24-26/22 for acute on chronic systolic HF, bacterial and crytogenic PNA, Covid (+ on 7/23), COPD exacerbation and CKD3.  Readmitted on 8/1 for acute on chronic respiratory failure with hypoxia and PNA. Subsequently decompensated - transferred to ICU, intubated and placed on pressors. Developed rapidly worsening refractory pressor dependent shock and multi-system organ failure. Transitioned to comfort care. Expired 8/5. Tx'd with meropenem, cefepime, methylprednisolone, and nystatin.
The first menstrual cycle following the vaccine was much heavier than previous ones; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27May2021 (Lot number: EW0153) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included Anxiety (unspecified if ongoing). Concomitant medication(s) included SERTRALINE. The following information was reported HEAVY MENSTRUAL BLEEDING (non-serious) with onset 06Jun2021, outcome not recovered. Patient did not had known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported that the first menstrual cycle following the vaccine was much heavier than previous ones. Each month since, the amount of bleeding during my cycles has increased from the previous month. I should have probably went to the ER, but I was not thinking right nor did I know this be from the vaccine & could be a sign of something more serious. I had Doctor appointments set up and if I experience this again would be going to the hospital as I cannot see how it can get worse than it did last cycle and me still live. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Shivering, achiness started during the night after my injection. Still achy the following morning.
Lips swelling; eye lid swelling; Itching; Hives; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (Lips swelling), SWELLING OF EYELID (eye lid swelling), PRURITUS (Itching) and URTICARIA (Hives) in a 48-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included MONTELUKAST, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced LIP SWELLING (Lips swelling), SWELLING OF EYELID (eye lid swelling), PRURITUS (Itching) and URTICARIA (Hives). At the time of the report, LIP SWELLING (Lips swelling), SWELLING OF EYELID (eye lid swelling), PRURITUS (Itching) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Arteriosclerotic cardiovascular disease.    On 16-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 26-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medication was reported.  Reportedly, patient tested positive for COVID-19, 10 days after administration. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
This spontaneous report as received from a Medical Assistant refers to a 6 month old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 27-FEB-2018 the patient was vaccinated with third dose of LIQUID PEDVAXHIB from lot N022167 expiry date 08-FEB-2020 for prophylaxis (inappropriate schedule of drug administration).  No adverse effect reported. No additional information was provided.
Flushing on chest; loose stool; urgency to go tobathroom for two days; This is a spontaneous report from a contactable other healthcare professional, the patient. A 56-years-old, non-pregnant female received first dose of BNT162b2 (PFIZER BIONTECH mRNA COVID-19 vaccine; Lot number: UNKNOWN) via an unspecified route of administration in right arm on 23Mar2021 at 13:30 (at the age of 56-years-old) for COVID-19 immunisation. The patient medical history includes supraventricular tachycardia. Concomitant medications include atenolol (MANUFACTURER UNKNOWN) taken within two weeks of vaccination. The patient has known allergy to aspirin(MANUFACTURER UNKNOWN). Prior to vaccination, patient has not been diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 14:30, the patient experienced flushed chest and loose stools with urgency to go the bathroom for two days. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care The clinical outcome of events flushed chest, loose stools and increased stool urgency was unknown at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a 79 year old female patient with hypertension. The patient's medical history included being allergy  to LEVAQUIN, causes muscle pain. On 02-JUN-2014, the patient was vaccinated with ZOSTAVAX lot # J013453 expiry date 24-JAN-2015, 1 subcutaneous injection in the left arm, it was administered very low on the arm near her elbow, unknown indication recommended by doctor. Concomitant therapies included Metoprolol (manufacturer unknown). On 03-JUN-2014 (also reported as 02-JUL-2014), the patient developed a hard lump, redness, soreness, itching at the injection site and swelling, itching of both eye lids with burning and her upper cheek is swollen. Patient used ice for her eyes. As of 06-JUL-2014, it was unknown if the patient will continue to receive ZOSTAVAX. There has been some improvement of her left arm but she continues to have the hard lump, redness, soreness, itching at the injection site and swelling, itching of both eye lids with burning and her upper check is swollen and the outcome of the injection being administered too low was unknown. Additional information has been requested.
Fever of 100.5-101, for 20 hours. Chills. Sore and swollen joints. Headache that lasted 12 hours. Some burning in my chest. Very itchy, burning eyes that could not be relieved with eye drops. Fatigue, dizziness, and some disorientation. A week later I am still experiencing strong fatigue and weakness, and burning eyes that is not as bad but still bothersome.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Vaccine on 4/6/2021. Patient admitted for septic arthritis 9/9/2021. Patient began to experience respiratory symptoms on 9/11/2021. Patient received: ascorbic acid, broad spectrum antibiotics, dexamethasone, remdesivir, tocilizumab, and zinc. On 9/272021, patient was emergently intubated, shortly after went into cardiac arrest and CPR initiated.  Patient expired 9/27/2021 at 1447.
C/o immediate numbness, swelling that PM warm to touch after warm salt soaks afebrile - no local erythema - No red streaking - ER Dx: Muscle spasm (L) arm.
Pt. describes having "slight" fever for a few hours after received HBV on 02/10/2005.  Did not take temperature, but didn't think it would have been above 99 degrees F.  Temperature resolved itself without any intervention.
Went to ER 7/9/08 with c/o numbness & pain to the R arm and dizziness & headache.  Seen in office 7/10/08 with same complaints.
28NOV recvd vax 7AM exp h/a all day; some diarrhea;
Vaccine exposure during pregnancy; A spontaneous report was received from a consumer concerning a 34-years old pregnant female patient who experienced exposure to vaccine during pregnancy.   The patient's medical history was not reported. Concomitant medication reported mentions prenatal vitamins and baby aspirin.   The patient received their first of the two planned doses of mRNA-1273 (Batch number: 004M20A) intramuscularly in the right arm on 21 Jan 2021 for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of events the patient received their second of the two planned doses of mRNA-1273 (Batch number: 022M20A) intramuscularly in the right arm for the prophylaxis of COVID-19 infection.  Patient had a positive pregnancy test on 09 Oct 2021. Her last menstrual period was on 09 Sep 2020 and estimated date of conception was 24 Sep 2020. The patients estimated due date is 16 Jun 2021. On 21 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine. She would like to be enrolled to the pregnancy registry. Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not applicable as both doses have been taken.
At approximately 5pm, hive appeared to left eye area and then resolved. At 5:30pm, hives appeared to lips. At 6:15pm upper lip became swollen and experienced "itching all over". Took Benadryl PO and took a nap. Upon awakening at 8:30PM, all symptoms were resolved.
3 hours after vaccines: Zombie like behavior, extreme lethargy, pain at injection site. 8-10 hours after vaccines - Fever of 101.7, higher in the middle of the night. Irritability, inability to sleep, crying. 15 hours post vaccines - severe diarrhea, refusing to eat meals/bottles, rash and red spots around his eyes and mouth, multiplying. Broken blood vessels on one ear (so far). Continued fever - just got a message from daycare that he has a high fever and a parent needs to come pick him up.
Chills, nausea, fever, muscle aches and weakness. I had similar, but less severe, reactions to first two vaccines (this was booster). I felt so bad I wanted to go to hospital, but figured hospital was still full of unvaccinated Covid patients and care being rationed and would rather die at home than in that situation. I fully understand the importance of vaccinations, but being this sick is a big factor. If another booster or an annual vaccine is recommended, I will not get. I honestly thought I was going to die.
PT VACCINATED WITH DTP DEVELOPED NEUROLOGIC RX TO DTP SCREAMED FOR 2 HRS, INCONSOLABLE.
Information has been received from a registered nurse who reported that VAQTA 25/0.5 U/ML (dose, route and lot number were exposed to 57F for 418 hours. The excursion was not supported. He stated that he was not sure if any of the doses were administered to patients. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
I had a sharp pain my thigh, I went to the doctor to check if it was a blood clot. But the results stated it wasn't, I still have couple more appointments to see what is going on. So far they think it might be a pinched nerve.
covid + on 1/21/21; admitted to hospital due to infection Narrative: Patient received the first dose of the COVID vaccine on 1/12/21. The patient tested positive for COVID 1/21/21. Admitted to Hospital on 1/23/21. Patient developed fever, cough, SOB, and diarrhea.
Patient was 16 years and EUA for Moderna recommends for age 18 and older.  No adverse reactions from vaccine
pt recvd vax & 1 hrs p/dose 2 exp erythema, severe tenderness, edema of arm for 3 days; followed by ecchymosis & pain for several days; cold compresses recommended 3rd day of dose 2; painful arm lasted approx 12 days;
On 01/22/02, the child received his fifth injection of Infanrix. On 01/23/02, he received injections of IPOl and MMR. Subsequently, on 01/25/2002, he experienced "severe" swelling at the injection site. The area was "very, very. red, hot and painful". The mother took the child to the emergency room; the emergency physician prescribed diphenhydramine hydrochloride (Benadryl) and a cephalosporin as if the diagnosis were cellulitis". The physician discontinued antibiotic after 24 hours because it was "obvious" to him that "this was a reaction to the vaccine". The physician stated that the cellulitis was moderate in severity and related to Infanrix administration. The cellulitis resolved on 01/27/02.
Large, itchy red spot surrounding injection site; darker, harder spot in the center currently.   Size has increased from approximately the size of a quarter when first began Tuesday, March 16, 2021, to a 5-inch by 5-inch spot today, Thursday, March 18, 2021.  Began taking Benadryl and using hydocortisone cream on Wednesday, March 17, and also taking Tylenol and Advil combination. So far, it is getting larger and worse, except for the itching. Itching has improved.
Drug allergies: Prevnar, Hydrocodone, Nickel; This is a spontaneous report from a Pfizer sponsored program. A contactable other hcp reported that a 45-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at single dose for immunization, hydrocodone (manufacturer unknown), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication, nickel (manufacturer unknown), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced drug allergies with pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), hydrocodone, and nickel on an unspecified date. The action taken in response to the event for hydrocodone and nickel was unknown. Outcome of the event was unknown.   Information on the batch number has been requested.
Immediately while receiving the vaccine, I tasted metal. Within under 24 hours I had really bad pain in the right side of my neck that radiated to the other side, my back, toward my spine, and right trapezius muscles. The pain stayed for a while. I also experienced fatigued and nausea for one day. The pain stayed in my neck and trapezius muscles. It radiated almost around the inside of my right arm, and the pain still remains in my neck. Within 2 weeks I started developing strong pressure in my right ear. I had tinnitus in my left ear. The muscle ache has diminished but still slightly present. The pressure and tinnitus remain. I was treated and found to have bilateral benign paroxysmal positional vertigo. Those symptoms are managed but the tinnitus remains constant. I took TYLENOL a couple of days.
Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. The physician reported that the patients were vaccinated with dose of improperly stored ROTATEQ (dose not reported, lot number L000425 with expiration date 21-JUN-2016, orally) on unspecified dates starting on or after 14-SEP-2015. No adverse effect was reported. This is one of several reports received from the same reporter (other linked case # 1510USA010197). Additional information has been requested.
Red, warm arm with some vesicular rash over (R) upper outer arm area x 7" LX 3" W
This spontaneous report was received from a 62 years old female Registered Nurse refers to herself. No medical history, drug allergy and concurrent condition was reported. On 26-JAN-2015, the patient was vaccinated with ZOSTAVAX 1 single shot, subcutaneous (Strength and lot number were not specified) for the prevention of shingles. Concomitant therapy included multiple unspecified medications. Approximately on an unknown date in January 2015, the nurse reported that after received ZOSTAVAX she experienced pain in the left shoulder blade, injection site was warm to touch and red. She had also developed post herpetic neuralgia (PHN). The patient was treated with ibuprofen. No intervention to prevent serious criteria was reported. No lab diagnostic studies were performed. Patient sought medical attention by spoken with physician. No product quality complaint (PQC) involved. The outcome of events was reported as not recovered/not resolved. Reporter causality assessment was not provided. Additional information has been requested.