chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hot arm of injection site; Hard arm of injection site; Redness of the arm of injection site; Chills; Fatigue; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE PAIN (Arm soreness), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism since an unknown date. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE WARMTH (Hot arm of injection site), VACCINATION SITE INDURATION (Hard arm of injection site), VACCINATION SITE PAIN (Arm soreness), VACCINATION SITE ERYTHEMA (Redness of the arm of injection site), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took no treatment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
4/5/2018 VARIVAX. 4/13/2018 Nausea, fatigue and joint aches. 4/15/2018 rash LEFT arm then spreading. Headache and light sensitivity. O) well appearing T 99.7, neck supple, LEFT lateral upper arm (site of injection) several grouped clear vesicles on bed base Face, upper extremity torso with isolated clear vesicles on red base P) BENADRYL at HS, Acetamiophen, Ibuprofen prn, No ASA. Self isolation, No clinicals ZOVIRAX 800 mg QID x 5 days.
Fever started at 9:00 pm with severe chills and body aches. Vomiting started at 2:00 am 2/04/2021 with 4 total bouts and inability to keep down water. Significant nausea and dizziness upon sitting up. I was instructed to go to urgent care by my PCP and was seen at 5:15 pm. I was given anti-nausea meds. Mild nausea lasting 4 days after injection.
pt recvd vax 30OCT92 & on 9NOV92 had fine red flat itch rash on chest, legs, & torso as well as arms; low grade fever x 2 days (100-101); no local reaction noted & devel a chest cold that resolved p/4 days;
This spontaneous report as received from a nurse via a company representative refers to 2 female patients in their 20' who were siblings. No informations regarding the patients' pertinent medical history, concomitant medications, drug reactions oa allergies was provided. On unknown dates, the patients were vaccinated with 3 doses of GARDASIL injection (doses, route of administration, lot#, and expiration dates were not provided), for prevention of Human Papillomavirus (HPV). On unknown dates, the patients experienced fertility issues. They were told by the physician, that the fertility issues were because they received GARDASIL in the past. The outcome of fertility issues was unknown. The relatedness between the adverse event and GARDASIL was not provided by the nurse. Additional information is not expected, as there was no consent to contact the reporter.
Vaccine given to 16 year old. Moderna approved for age 18 and older.
At approximately 12:30 pm, I became dizzy while walking. I had to stop and steady myself from falling. The event lasted approximately 5 minutes. After this event, I felt very fatigued for the rest of the day.
Narrative: Fully vaccinated and found to be COVID positive upon admission. Presented with left hand pain/swelling concerning for potential infectious tenosynovitis of left hand. Incidentally found to be COVID positive - thought to possibly be convalesced as patient reported being positive 1.5weeks ago. No hx of prior COVID infections.
pt recvd vax; 3-5 mins generalized sz on 4dec94;f/u test CAT scan head nl; EEG pending;
Four hours after the shot there was swelling and pain at the injection site. I had a headache and body aches and had to go to bed. It was like the flu times three. I was up all night basically because I couldn't get comfortable. About 24 hours later I was finally feeling well enough to get up. The day after that, I noticed I couldn't take a deep breath and I was coughing a lot. I did a virtual visit with my doctor, and she prescribed an inhaler and prednisone. The inhaler helped a lot, and I did not end up needing the prednisone. I have bronchial asthma and this issue was stemming from my bronchial tubes. I am fatigued still but not in pain. I did have diarrhea this morning 11/15/2021 though.
The pt was immunized with MMR, IPV, and DTaP. The pt went to the ER on 04/25/2002 and was diagnosed with strep throat. She was prescribed zithromax. Her condition got worse in the night so she was taken back to ER at 3:30am, still vomiting and with a fever of 103 deg. F. Dr. gave her suppositories for vomiting and hydrocodone for pain. Later she developed a rash that looked like hives and/or blisters. The rash started on her hands and arms. The rash faded. On 04/29, the pt was feeling better and began to eat.
Hospitalized (11.9.21);  COVID-19 positive (11.11.21); fully vaccinated  Admission Date: 11/9/2021 Discharge Date: 11/18/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia  Pneumonia due to COVID-19 virus  COVID-19  HOSPITAL COURSE: Patient is a 85 y.o. male who presented with acute respiratory failure with hypoxemia secondary to COVID pneumonia.  Patient had J and J vaccine breakthrough case COVID-19.   He had Improved throughout hospitalization completed remdesivir and continued on initially IV followed by oral dexamethasone.  Given furosemide 40 mg x 1 11/15/2021.  Chest x-ray negative.  Procalcitonin negative. Patient discharged back to extended care facility.  Medically stable at this time.  Awaiting results of COVID-19 test prior to discharge.  Continue Decadron 6 mg orally q.day x3 days.  Consult PT for evaluation and treatment when returns to Hospital. * Pneumonia due to COVID-19 virus Assessment & Plan Patient has weaned from 10 L down to 5L at this time.  Overall  Improving.  COVID +: 11/8/2021 - tested at ECF.  Patient is vaccinated with J&J.  Day 9. PO Decadron.  Completed remdesivir on November 15th.  Continue VTE prophylaxis with enoxaparin.
Local erythema and pain at injection site and fatigue for three days. Used TYLENOL for relief. Not clear duration since still having symptoms today.
Pt w/ hx of severe allergy to nuts.  Hx of Fainting/feeling hot w/ allergy testing @ age 9.  Pt c/o flushing/sweating and dizziness 5mins after vaccination BP 114/70, HR 88, RR 16, O2 Sat 98% RA -- > 120/68, 86, 18, 100% RA.  Pt VSS, extremities warm to touch.  Pt stable and released from vaccination site ~35mins after vaccination.  Pt transferred via wheelchair w/ Dad as a precaution.
HEADACHE; VOMITING; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 16:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 12-APR-2021, the subject experienced vomiting. On 12-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomiting, and headache. This report was non-serious.
Patient states that after shot was given she had a lack of energy which is still ongoing. She also states that the vaccination has affected both her short term and long term memory. Patient also states that she has a lack of motivation since vaccination given.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Additional Details: PATIENT RECIEVED THE 1ST DOSE OF MODERNA COVID-19 VACCINE AND WHILE WAITING FOR THE 15 MINUTES OBSERVATION PERIOD, PATIENT FAINTED AND HIT HER HEAD. PATIENT WAS RESPONSIVE BUT WAS HYPERVENTILATING, MASK WAS REMOVED TO HELP HER BREATH BETTER. EPI WAS NOT ADMINISTERED. 911 WAS CALLED AND VITALS WERE TAKEN AND PATIENT WAS TAKEN OUT OF THE STORE FOR ADDITIONAL TEST AND WORK UP. PATIENT WAS CONTACTED LATER TO CHECK UP ON HER AND SHE SAID EVERYTHING IS FINE AND SHE IS DOING WELL.
Tranverse myelitis (suspected); Demyelinating neuritis (suspected); Neurological symptoms that have progressed / Band like effect around her abdomen; This case was reported by a physician via call center representative and described the occurrence of myelitis transverse in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2020, the patient received the 2nd dose of Shingrix. On 17th July 2020, 2 days after receiving Shingrix, the patient experienced myelitis transverse (serious criteria GSK medically significant), demyelination (serious criteria GSK medically significant) and neurological symptom. On an unknown date, the outcome of the myelitis transverse, demyelination and neurological symptom were not recovered/not resolved.   It was unknown if the reporter considered the myelitis transverse, demyelination and neurological symptom to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported but could be 59 or 60 years. The patient developed neurological symptoms that have progressed over the days. It was started as a band like effect around her abdomen, now all the sensation was going all the way down to her feet. The reporter consented to follow up.
The pt experienced a red and swollen injection site with a fever and prolonged crying for longer than 6 hours.
I had flu like symptoms on Saturday the 10th of the day after I got the vaccine but this report is intending to report redness, pain, heat  and swelling on my upper arm that I received the injection on and this is the Pfizer vaccine.  I know the Moderna vaccine has been linked to what they are calling Covid arm so I wanted to report something similar happening with the Pfizer vaccine
On October 22 I began experiencing an extremely dry, scratchy right eye. By October 25 I had full-blown Bell's Palsy on the right side of my face. I saw my eye doctor on October 26 and he recommended Refresh Mega-3 and Refresh PM eyedrops. I also saw my regular doctor, on November 16 and he prescribed Prednesone  for a 6-day course.
Patient completed COvid-19 vaccination series on 2/10/2021, was diagnosed with Covid-19 on 6/30/2021, and died on 7/14/2021 with Covid listed as a condition contributing to his death.
Arm is red, swollen, tender, itchy. nausea, muscle pain, fever 102.3, fatigue, headache
Needle and syringe were not tightly connected together. Some vaccine spilled from connection point. Per vaccinating pharmacist majority of dose was administered. No adverse effects reported by patient
Hypotensive, bradycardia, dizziness, sweating. Patient recovered quickly after approximately 20 minutes, no transport or medications needed.
Fever, Chills, extreme head ache and severe body aches, weakness, all lasting 24 hours
This spontaneous report was received from an approximately 39 year old female patient referring to herself, who stated that she was allergic to zoledronic acid, MACROBID, iodine, IVP dye (iodine allergy), technetium contrast (contrast media allergy), computerized tomography (CAT) scan contrast (contrast media allergy), penicillin (manufacturer unknown), sulfas and sulfonamides, morphine (manufacturer unknown), MS cotton, PERCOCET (also reported as PERCASET), DILAUDID, unspecified adhesives, tetradram, ciprofloxacin, CEFTIN, bacitracin, prednisone steroid (also reported as pregnisone), tramadol, NEURONTIN, LYRICA, lidocaine, ROBAXIN, fluorometholone, MOTRIN, CELEBREX, niacin, NAPROSYN, formula 7, mold (mycotic allergy), bees (allergy to arthropod sting), pollen (pollen allergy), pine needles, weeds and seafood (food allergy). On an unknown date in2016 (reported as fall of 2006), the patient was vaccinated with a dose of Pneumococcal vaccine (manufacturer unknown) (lot#, expiration date, dose and frequency were unspecified) intramuscularly in her arm. Concomitant therapies included an unspecified cholesterol medication (manufacturer unknown), PRO AIR 90 mcg, VICODIN, PRILOSEC and FLOVENT. On an unknown date in 2016 (reported as fall of 2006) after vaccination, the patient experienced a sore arm and the area around the injection site tender. The patient also stated that she fully recovered within 2 days after being vaccinated with pneumococcal vaccine (manufacturer unknown), and that she was treated with TYLENOL. The patient did not seek for medical attention and she was not hospitalized. No PQC was involved. The relatedness of pneumococcal vaccine (manufacturer unknown) with the adverse events was not reported. Additional information has been requested.
Tightness in the chest area and feels heavier; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 12:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 26Apr2021, the patient experienced tightness in the chest area and felt heavier. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tightness in the chest area and felt heavier was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Just a little itching; He is experiencing a low grade fever; he just feels unwell.; a headache; Some discoloration on his arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Just a little itching"; PYREXIA (non-serious), outcome "unknown", described as "He is experiencing a low grade fever"; MALAISE (non-serious), outcome "unknown", described as "he just feels unwell."; HEADACHE (non-serious), outcome "unknown", described as "a headache"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Some discoloration on his arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She sat on the floor and fainted; Stomach ache  less than 24 hours after receiving vaccine.; Being dizzy less than 24 hours after receiving vaccine; She came to a few seconds later she was vomiting; This case was reported by a consumer via call center representative and described the occurrence of fainting in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fainting (serious criteria GSK medically significant), stomach pain, dizziness and vomiting. On an unknown date, the outcome of the fainting, stomach pain, dizziness and vomiting were unknown.   It was unknown if the reporter considered the fainting, stomach pain, dizziness and vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comments: The patient reported case for herself. The patient received Shingrix dose 1 about 6 months ago from reporting (did not had the exact date) and reported having a stomachache and being dizzy less than 24 hours after receiving vaccine. The patient stated that evening she got up in the middle of the night and when she got to the bathroom, she sat on the floor and fainted, she stated that when she came to a few seconds later she was vomiting.    The patient was afraid to get dose 2 but would consult her health care professional.  The reporter did not consent to follow up.
On April 6 at about 9:30pm, stomach pains started. I could not sleep all night from pain. I called out of work on April 7 at about 5:00am from severe abdominal pains. My boss who is a critical care nurse asked me a few questions and told me to go to the emergency department immediately. I went to the emergency department at about 9:30 am on April 7. After a CT scan, doctors said I had appendicitis and would need surgery as soon as possible. I was taken into surgery I believe in the afternoon for an appendectomy. They admitted me to the hospital after surgery but I was able to go home that night around 8:00 pm.
FROM THE TIME THE PHARMACIST INJECTED THE VACCINE, (PFIZER) I FELT THE VACCINE TRAVEL DOWN MY ARM, WITHIN MINUTES I BECAME VERY ITCHY
Stiff neck 2-3 hours post vaccination, dizziness at night along with headache, congestion, severe sore throat at times bloody sputum.
When I was sleeping, I felt like pressure on my left arm; I feel like when you have a panic thing like and I have been feeling like that; It feels like, it is just a weird pressure and pain going all the way down like to my arm fingers; It feels like, it is just a weird pressure and pain going all the way down like to my arm fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EW0183, Expiration Date: 31Aug2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1st dose, Batch number: EW0158, Expiration date: 31Jul2021), for Covid-19 immunization. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "When I was sleeping, I felt like pressure on my left arm"; PANIC REACTION (non-serious), outcome "unknown", described as "I feel like when you have a panic thing like and I have been feeling like that"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "It feels like, it is just a weird pressure and pain going all the way down like to my arm fingers".  Additional Information: It was reported that, Consumer stated, I am just wondering is it some normal symptom? I just got my second dose of the Pfizer vaccine and what I noticed is like at night, when I was sleeping, I felt like pressure on my left arm and when I woke up, I feel like when you have a panic thing like and I have been feeling like that, it feels like, it is just a weird pressure and pain going all the way down like to my arm fingers.  No follow-up attempts are possible. No further information is expected.
Falling, not able to walk, pain, no use of hands, paralysis from the neck down.
Information has been received from a registered nurse concerning a 27 month old (now 26 year old) female with no known drug reactions/allergies and medical history, who in August 1983 received the first dose of MMR II (route and lot numbers not reported).  In August 1984, the patient was administered the second dose of MMR II.  The registered nurse stated that the patient had titers completed in 2007, the measles results were equivocal, the patient was given a third dose of MMR II (route and lot number not reported).  In March 2009 the patient's titers were equivocal.  The titers were repeated in April 2009, the patient was seronegative for measles.  The patient sought medical attention by follow up with the nurse.  Additional information has been requested.
general malaise , Fatigue, poor interest in activities , hypoactivity, pulmonary embolism Narrative: Patient transferred to ER for evaluation. Physician at facility reported marked deterioration, hypoactivity and slow mentation s/p COVID vaccine second dose 1/8/21. Cough also reported x 1 week. Patient evaluated at ER on 1/20/21 and admitted to internal medicine ward with diagnosis impression pulmonary emboli, aspiration pneumonia and urinary tract infection.
HepA vaccine given 5/12/10, 10:16. Mother called Dr. 5/12/10 PM regarding fever following vaccine. Advised to give TYLENOL and MOTRIN and to schedule appointment in the office in the morning. Mom called office 7:30, 5/13/10 to report fever of 103.4 axillary and seizure with vomiting. Appointment scheduled for 9:00 that day. Advised to give child tepid bath but do not allow to chill. At office visit with Dr the child was tired, irritable, alert and appropriate, temp 98.6 degrees temporal. Follow-up: Seen in office by Dr. 5/13/10 at 9:00 AM. Dx: Symptom, fever, unspecified (780.60) Febrile Seizure.
Severe brain bleed; Severe thrombocytopenia/; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of THROMBOCYTOPENIA (Severe thrombocytopenia/) and CEREBRAL HAEMORRHAGE (Severe brain bleed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced THROMBOCYTOPENIA (Severe thrombocytopenia/) (seriousness criteria hospitalization, medically significant and life threatening). On 09-Jun-2021, the patient experienced CEREBRAL HAEMORRHAGE (Severe brain bleed) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, THROMBOCYTOPENIA (Severe thrombocytopenia/) and CEREBRAL HAEMORRHAGE (Severe brain bleed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information for the events was not provided. Very limited information regarding these events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Additional event was added.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
10 hours after vaccine when walking out, fainted, hit head on carpet - was dazed for 10 minutes. Decreased BP, glucose was ok.