chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable pharmacist who reporting for herself via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration a year ago (in 2017) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain, fever, felt like there was a stone on her arm, sweating, discomfort, and numbness on an unspecified date after use of product. The outcome of all events was unknown.
Patient came into pharmacy on 11/6 and told pharmacist that she had the worst reaction to the flu shot. A large portion of her upper arm was swollen and red/bruised. A week later the skin was still very observably bruised but the area had gotten smaller according to the patient. She was in pain for a few days but now she is better. Patient just wanted us to know what had happened to her. She's fine now.
Chills; low grade fever (100.2); some soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6207,  Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 11Mar2021 14:30 (at the age of 67-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included cardiovascular disease, GERD and lung blood clots all from unknown date. Concomitant medications included rosuvastatin, rivaroxaban (XARELTO), metoprolol, losartan and Famat all taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has been diagnosed with COVID-19. On 12Mar2021 09:00, the patient experienced chills, low grade fever (100.2) and some soreness at injection site. Therapeutic measures were taken as a result of the events included TYLENOL. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Mar2021.    No follow-up attempts are possible. No further information expected.
slight itching on his head, back and on right side; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received 1st dose and approximately 1 week developed slight itching on his head, back and on right side. This case has been linked to US2019222822, reported by the same reporter.
shaking; chills; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), CHILLS (chills), VOMITING (vomiting) and NAUSEA (nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced TREMOR (shaking), CHILLS (chills), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, TREMOR (shaking), CHILLS (chills), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  Treatment information was not provided.  Action taken with mRNA-123 is not applicable.
Patient received their first COVID vaccine shot on 3/11 and on 3/12 had a sore arm. On 3/16, patient woke up with a dull headache that lasted through the day and she felt very lethargic. The patient did not experience fever or body aches/chills. On Friday, 3/19, The patient woke up with nerve pain in their right shoulder radiating down into the right index finger. Over the course of that day and the following day, the patient reports the nerve pain spread to her other arm and down into her legs, feet, and toes. At this point she also experienced feeling colder and hotter, she did not have a fever at any point. The nerve pain symptoms were mostly resolved by 3/22. Patient reports she is still experiencing some on and off tingling sensations in her extremities.
Patient was admitted to their local hospital on 3/9/2023 for concern of a toe infection. Patient previously had part of his second toe, left, amputated on 2/4/2023. During this admission on 3/9/2023, patient had the rest of his second toe, left, surgically removed on 3/10/2023. Patient was discharged on 3/12/2023. Patient was discharged with antibiotics for two weeks: Doxycycline Hyclate 100 mg BID and Cefadroxil 1000 mg BID. Patient is recovering at home, and reported feeling well from the surgery. Patient uses a scooter to help him move around. Patient was vaccinated with the Janssen Ad26.CoV2.S vaccine on 2/21/2023. At the time of Day 28 call, patient denied any symptoms of fever, cough, sore throat, headache, and no change in taste and/or smell. External medical records have not yet been received at time of event reporting--no labs to report.
Pfizer-BioNTech COVID-10 Vaccine - case of COVID-19 resulting in hospitalization. Pt presented to ED of facility on 4/20/21 with dry cough, malaise, altered sense of taste/smell and worsening dyspnea.  Afebrile (T=98.6 F). Symptoms began approximately 4/13/21.  Reportedly was hypoxic at PCP's office prior to presentation to ED.  S/P 2 doses of the Pfizer-BioNTech COVID-19 vaccine - 1/29/21 and 2/19/21 (dates obtained from database).  Admitted to inpatient unit 4/20/21. Treated with dexamethasone 6mg po daily, remdesivir (x2 doses prior to discharge). Transiently required increase in oxygen by nasal cannula but remained on baseline of 3L oxygen majority of admission.  Discharged home 4/22/21.
About 10 minutes after vaccine administered patient started experiencing a racing heart sensation. Described slight shortness of breath. Admitted to history of anxiety, has home xanax. Has not taken any today.  Patients HR was at 110 initially after monitoring for about 15 minutes it stabilized to mid 70s. Patient has remained in the mid 70s for 20 minutes without any interventions. Complete resolution of symptoms.
Patient flexed arms in, eyes rolled back, head extended back, collapsed, and enuresis. No shaking observed. Loss of consciousness for several seconds.
I had no adverse event after receiving the vaccine. I tested positive for COVID-19 in 12/2022. I had a runny nose, stuffy head and sneezing. I never had a fever. I wanted to test before going to see a friend and I'm glad I did.  I contacted a provider through telehealth visit. I got a prescription for Paxlovid. I tolerated the medication without any complications. As of today, I do not have any lingering COVID-19 symptoms.
Sudden severe unexpected vertigo. Unable to lay down, eat, drink or sleep for 1 week. Nonstop vomiting and diarrhea; blackout spells. Taken to ER for emergency hydration. Had to miss 2 weeks of work.
Initial and follow up information has been received from a licensed practical nurse and a health professional concerning a 70 yr old white retired male with a penicillin allergy, IV dye allergy, COPD, recurrent bronchitis, osteoporosis and a history of smoking (ceased in 1980's) who on 07Feb06 was vaccinated IM into the right deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 651322/1044P). Concomitant therapy included doxycycline. Since the pt was vaccinated he has been achy in his arm. He had developed some redness and swelling as well. He also developed a headache, was not sleeping well and had been feverish with no documented temps. The pt was diagnosed with cellulitis and was treated with cephalexin (Keflex) 500mg, four times daily for seven days. The pt was advised to rest that arm and keep it elevated as much as possible. It was noted that if the pt's conditions worsened he should follow up with his primary care physician and the pt will follow up in prompt care as needed. It was also noted on 09Feb06, the pt called and complained that his right arm was red and sore and the redness to the right arm was spreading downward. At the time of this report, the pt fully recovered. No product quality complaint was involved. Additional information is not expected.
Information has been received from a health professional concerning a 9 yr old female pt with a history of fever of 101 degrees F on 26Mar05 or 27Mar05 who on 29Mar05 was vaccinated with a dose of hep A virus vaccine inactivated (lot645995/0675P). On 29Mar05 within 2 1/2 to 3 hrs the pt developed an itch all over, good size welts on her chest, back, sides, and hips. She was also light headed and had slight diarrhea. She was treated with diphenhydramine hydrochloride (Benadryl) and was recovering at the time of the report. Additional information has been requested.
SLEEPY; BP NORMAL; BAD CHILLS AND RIGOURS; FATIGUE; FEVER; This spontaneous report received from a parent concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced sleepy. On 06-APR-2021, the subject experienced bp normal. On 06-APR-2021, the subject experienced bad chills and rigours. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced fever. Laboratory data included: Blood pressure (NR: not provided) 130/84, Body temperature (NR: not provided) 103 F, and Oxygen saturation (NR: not provided) 100 %. On 06-APR-2021 23:00, treatment medications included: paracetamol. On 07-APR-2021 04:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepy, bad chills and rigours, and fatigue on 09-APR-2021, and bp normal, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420331.
Spontaneous urticaria sparing only soles of feet lasting 7 days. resistant to antihistamines and topical steroid. treated with oral methylprednisolone and depomedrol injection.
Redness, swelling, itching, and pain at the injection site. It increased to a rash, redness, swelling, pain, and itching, over most of the upper arm of the ide vaccine was administered to. It began a week after the vaccine was given. So far it is ongoing but has gotten a little better. was severe for 5 days. It is now day 6 and it is still present.  Put on aloe several times a day to relieve the itching. Also tried Ketoconazole and Neosporin but they didn't help.
Started having a post nasal drip, cough and had a fever. Went to my doctor and tested positive for the Flu with Bronchitis. Prescribed Albuterol Inhaler, Zpack, and  Prednisone.
Seen in ED on  21 April; Dx: Atypical chest pain & Myocarditis; Transferred to Hospital. Did also get an Anthrax Vaccine 28 Feb 2018 #4 in series; mfg MIP; lot number 300021A.
3 Min post vaccine patient experienced vasovagal syncope assessed patient unresponsive to voice commands proceeded to give patient sternal rub patient was pale in color diaphoretic also c/o wanting to vomit. Patient assessed  V/s at 10:01 am BP 108/68 HR 80 SP02 94% Provider assessed patient at 10:10 am patient spo2 99%  A&Ox3 pulse +2 bilateral lungs clear to auscultation, regular rate and rhythm. Patient states she has a history of syncope.  Vital signs at 10:07am BP 114/68 HR 85  SPO2 94% no further complaints patient feeling better  Vital signs at 10:13am BP 120/70 HR 83 SPO2 99%  no further complaints patient able to ambulate with no assistance 0 c/o dizziness. Patient left vaccination site with no signs of distress and c/o
The first two days, I had a fever, drowsiness and increased hunger. The third day I became extremely weak and developed tachycardia and sinus arrhythmia.  A visit to a cardiologist, who conducted a halter and an echocardiogram determined that I now have sinus arrhythmia and a slight thickening of my heart muscle (left ventricular hypertrophy). I had no previous health issues or heart issues before receiving the second dose of the vaccine.
Red rash at site of shot - went to chest, neck & face - tingling started 2 days after, neck swollen on side of body vaccine admin.
Received shot 1 on 2/16 and shot 2 on 3/18.  Woke up on 3/24 and experienced a vertigo episode for the first time ever. Have not experienced vertigo since but dizziness and light headed ness has persisted constantly since 3/24. Have also experienced intermittent nausea.
Pressure headache, malaise beginning about one hour after shot. Still experiencing this over 24 hours after shot.
Patient complained of dizziness after receiving flu shot. Color good, skin warm and dry. 9:56 am  BP= 120/64, P= 78. Patient walked with assistance to nurses office. She was lying down in nurses office and symptoms improved. Lung sounds were clear but slightly diminished at left base. School nurse also listened to lung sounds. She had slight cough and wheezing. She had only had a donut for breakfast and a few sips of hawaiian punch at 8am. She was given 16.9 oz H2O to drink. 10:00 am BP= 122/64. P= 78. symptoms were resolved by 10:10 am and parent came to pick student up from school.
Patient was given the Pfizer Covid vaccine when the patient was 11 years and 10 months old. No adverse effects reported. Patient will receive second dose after her 12th birthday.
Patient presented with red raised bumps and inflammed lower left arm right above the elbow.  Patient complained of pain and itching.
Surgery to take out 2 encapsulated cancer tumors of his left lung; This spontaneous case was reported by a consumer and describes the occurrence of LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (because he is taking Tagrisso) and Lung cancer. Concomitant products included OSIMERTINIB MESILATE (TAGRISSO) for Lung cancer, MULTIVITAMIN [VITAMINS NOS], LEVOTHYROXINE SODIUM (SYNTHROID), SODIUM BICARBONATE, AMLODIPINE and DOXYCYCLINE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) (seriousness criterion medically significant). The patient was treated with Surgery (On 03-May-2021 he got surgery to take out 2 encapsulated cancer tumors of his left lung) for Lung neoplasm malignant. At the time of the report, LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LUNG NEOPLASM MALIGNANT (Surgery to take out 2 encapsulated cancer tumors of his left lung) to be unlikely related.    Treatment medication was not provided.  Company comment: Based on information provide and considering that the patient had medical history of lung cancer for which the patient underwent surgery the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on information provide and considering that the patient had medical history of lung cancer for which the patient underwent surgery the event is assessed as unlikely related to mRNA-1273.
Patient was very nervous before vaccine was given which was about 425 or 420pm. Than after patient was sitting for observation he stood up to leave+ told "greeter" that his throat was closing. Patient spoke language Greeter spoke language. Pt sat down by nurse, vs taken- were stable, clear speaking from patient, no hives no itching no SOB, LS clear, Dr + Parametics immediately called
Fever 100-102 per patient history. Urticarial, blotchy, exanthem, tender outer and upper right arm.
The first vaccination went well.  The second vaccination, the morning after, I had severe headache (like a pinching pressure in my brain) my eyes hurt to move them and were severely sensitive to light or movement.  Swelling of hands and feet.  Fever (low grade), achy muscles, joint aches.
Symptoms (redness, swelling, induration, heat) started soon after shots given on 3/10/14. Apply warm compress, give TYLENOL for fever every 4-6 hr. Cortisone cream 1% twice a day 1 week.
Pt 13 years old received Pfizer 3rd Dose. Monitored for 15 minutes no adverse reactions or acute distress noted. Accompanied by Father.
first dose of Moderna COVID-19 Vaccine after receiving both doses of Pfizer in February; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (first dose of Moderna COVID-19 Vaccine after receiving both doses of Pfizer in February) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ACETAMINOPHEN, ATORVASTATIN, RISPERIDONE and TRAZODONE for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (first dose of Moderna COVID-19 Vaccine after receiving both doses of Pfizer in February). At the time of the report, EXTRA DOSE ADMINISTERED (first dose of Moderna COVID-19 Vaccine after receiving both doses of Pfizer in February) 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 medications included Dicyclomine, Colace, Donepezil.
Day after vaccine I felt very tired, then the next day 01/08/2010 I awoke with a headache that continued to get worse throughout the day. I took ibuprofen 400mg, twice during the day then 2 Exedrin migraine in early evening then the pain excelled and I took a very old Vicoden that made me fall asleep. Mild headache the following day that went away after 400mgs of Ibuprofen. I felt normal thereafter.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 10-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL (dose, route and site of administration were not reported, lot # K008931, expiration date 04-MAR-2017). No adverse symptoms were provided. This is one of several reports from the same reporter. Additional information has been requested.
My husband and I received the vaccination together.  The provider gave me the shot in my left arm and my husband said that he thought the shot was given too high. I did not know anything about that but his was also given high up on his shoulder. That night we both had shoulder pain but just attributed it to the effects of the shot that everyone pretty much gets.  Well, by Saturday, my shoulder hurt so much I thought I had a problem with my rotator cuff.  My husband and I did some light movements with our shoulders during the week of 3/15 to help our range of motion.  His is getting better, but mine is now hurting even in a state of relaxation. I went to my primary doc (Dr.  was not in so I saw the nurse practitioner) on 3/25 and she immediately sent me to Dr. on 3/25 and he took X-rays and an ultrasound.  He found nothing wrong with my bones but did see inflammation at the site of the injection. He would have given me a cortisone injection but that would not be prudent with my Covid Vaccine.  Because over the counter medication was not working, he prescribed 500 mg of naproxen to take for 10 days and put wet heat on the area and do exercises with the pain in mind.  (not to overdue). He said to come back 2 weeks after my 2nd shot and if the pain is still there, he will give me a cortisone shot.  I am so upset about this.
cough; nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and NASAL CONGESTION (nasal congestion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUSPIRONE and PRAVASTATIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COUGH (cough) and NASAL CONGESTION (nasal congestion). At the time of the report, COUGH (cough) and NASAL CONGESTION (nasal congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include: Vicks NyQuil.
Information has been reported by a physician concerning a male patient who on 26-NOV-2014 received a dose of VARIVAX (Merck) (lot number not reported) instead of a dose of ZOSTAVAX. The physician stated that it is easy to mistake the VARIVAX (Merck) box for the ZOSTAVAX box since they are both the color green. No adverse effects were reported. The causality was not related. The outcome of wrong drug administered and product confusion were unknown. No additional information was provided. Additional information has been requested. This is one of several cases received from same reporter.
1;55 pm during observation post vaccination, complaint of tongue tingling and numbness BP 148/94, P 112,RR 18, SPO2 97% on room air, Lung sounds CTA. 2pm  Benadryl 50 mg chewables given. EMS activated 220pm complaint of throat swelling and tightness BP 160/108, HR 114, RR 22, SPO2 9% Epinephrine 0.3 mg IM given, left thigh EMS arrival 2:34pm, EMS took over care,2;44 pm  started IV access, IVF , Administered Benadryl 50mg IVP and Methylprednisolone 125mg IVP BP 144/94, HR 120, SPO2 100%, RR 20 Ems transport to Winthrop Hospital Emergency room, Patient alert and oriented, GCS 15 in no apparent distress.
at injection site, swelling, warm to touch, hardness, redness that spread,  approximately 13.5 cm in width and 11.2 cm long, extreme fatigue, muscle pain, joint pain, chills (injection site not in deltoid, lower in mid arm approximately)  seen in emergency department, treated for cellulitis/allergic reaction.  given Doxycycline Mono 100 MG.  one tablet by mouth twice a day.  still note small area of firmness approximately 6.5 cm wide and 7.0 cm long.  slowly improving with antibiotics.
Face got swollen and I continue to experience sudden swelling of face, discharge/clotting when not on menstrual cycle, dizzy spells, fatigue, headaches/migraines ongoing, shortness of breathe.