chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe syncope; This is a spontaneous report from a non-contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:00 (at the age of 33years) as single dose for Covid-19 immunization. Medical history included oral allergy syndrome, polycystic ovarian syndrome, and Gluten, Apples, Almonds, Cherries allergy; all from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hcl and ethinylestradiol, norgestimate (TRI LO MARZIA), both taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe syncope on 03Apr2021 (12:45PM). The event resulted in Emergency room/department or urgent care. It was unknown if treatment was received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.
Pt given DTaP RT IM, Hib in LT IM about 3 hrs later brought child back to office with hives on legs and arms. Gave 12.5 mg/0.25 ml BENADRYL IM and sent child to ER.
Eye began watering non-stop; lesions appeared on side of neck/more lesions appeared on ears; scalp itching; dandruff; nerve pain; Shingles/shingles outbreak on my neck./determined to be disseminated shingles scalp, neck, ears, right eye; Originally thought it was heat rash/heat rash still present/heat rash on back of neck; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0176), via an unspecified route of administration in the left upper arm on 01May2021 at 10:30 (at the age of 43-year-old), dose 2, single for COVID-19 immunisation. Medical history included sinus problems, allergies to penicillin. Concomitant medications included fluticasone propionate (FLONASE) and loratadine (CLARITINE). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0162) administered via an unspecified route of administration in the left upper arm on 09Apr2021 at 15:30 (at the age of 43-year-old), dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at public health department. Around 5May2021 to 8May2021, the patient noticed heat rash on back of neck. On 08May2021, the patient had shingles. On 15May2021, about two weeks later, the patient noticed scalp itching, but she figured it was product dandruff. On 26May2021, the patient had shingles outbreak started on her neck. Originally thought it was heat rash. On 08Jun2021, the patient's eye began watering nonstop. The heat rash was still present and lesions appeared on side of neck. The patient was prescribed with antibiotics (z-pack) and steroid eye drops. By the end of week more lesions appeared on ears. Determined to be disseminated shingles on scalp, neck, ears and right eye. The patient received 2 rounds of Valtrex 3g for the events and also received gabapentin for nerve pain missed work on neck, right eye (as reported). Symptoms returned three weeks after finishing the medications. If known side effect would have went for treatment earlier. The patient stated that she missed seven days of work without pay and mentioned that she still would have recommend the vaccine, but people need to be aware it can stir things up. The events were reported as serious (persistent /significant disability /incapacity) and resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; No further information is expected.
patient was administered dose from a vial that was punctured 21 hours earlier/This was patient's 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered dose from a vial that was punctured 21 hours earlier/This was patient's 1st dose) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered dose from a vial that was punctured 21 hours earlier/This was patient's 1st dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered dose from a vial that was punctured 21 hours earlier/This was patient's 1st dose) outcome was unknown.        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.   Treatment medications were not mentioned. No concomitant medications were provided. Any other reactions to the vaccine were not reported
Vaccinated at 12:00pm  Around 6:00pm started to get a really bad headache at the back of my head.  This lasted all night, preventing me from sleeping.  Finally fell asleep around 5:30am still with a really bad headache.  Woke up at 11:00am.  Brushed my teeth and started to feel nausea.  I went back to my bedroom and I got lightheaded to where my vision was blurred.  Layed on the bed and felt really bad with a sweaty face and still nauseas.  Had someone bring me grapes and some tea and layed there.  I felt bad for about 45 min. then I fell asleep.  Got up about 3:30 hours later feeling better, but not 100%  Still a bit of a headache but nausea went away.  Today I feel back to my normal self.  I thought you'd like to know I did experience some of the side effects for your records.
04/13/2021 First day I had fatigue, I felt dizzy, it turned into vertigo, going to the right, I was cold, body aches, nauseous, weak, heart beat became irregular. I went to bed. I slept ok but the next morning around 4 am, I had chest and heart pressure pain. On 04/14/2021 I called my friend and they took me to the ER. They put me on heart monitor but did not see life threatening symptoms, no fever.
severe headache / had to go to the emergency room; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number AL734, expiry date 8th October 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date).   On 12th April 2021, the patient received the 2nd dose of Shingrix. On 12th April 2021, less than a day after receiving Shingrix, the patient experienced headache. On 7th June 2021, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows,: The patient had received 2 nd dose of Shingrix and since that day, started developing severe headache.  On 7th June 2021, the patient had to go to the emergency room due to severe headache.  The same symptoms were not reported after the administration of the first dose of Shingrix. The reporter consented to follow up.
Pt recvd MMR vax on 3JUn92 & on 7JUN92 vomitted x1, oral t101; 8JUN92 pt laid around tired; 2JUL92 parents went by bedroom & saw pt arms & legs jerking; seen by MD that day; jerking episoes are frequent; insomnia;
Mother reports she noticed child's left arm is red, hot to touch, tight and hard. Red area about the size of her fist. Mother reports that child is not showing signs of discomfort and does not have a fever. Nurse recommended cool compress and ibuprofen. Also recommended that mother mark the area to see if it gets bigger and seek medical attention if it gets bigger or she has any concerns.
This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (had clear urine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHROMATURIA (had clear urine). At the time of the report, CHROMATURIA (had clear urine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Pharmaceutical product complaint; did not received a full dose because of a malfunction; 12 months old received 4th dose of DTap; malfunction with a syringe; This case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 12-month-old male patient who received DTPa (Infanrix) (batch number Y4259, expiry date 30th March 2024) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th December 2022, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 6th December 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered, inappropriate age at vaccine administration and syringe issue. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, inappropriate age at vaccine administration, syringe issue and pharmaceutical product complaint were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comments: Doctor had a malfunction with a syringe of Infanrix, and a child did not receive a full dose. Infanrix was the patients 4th dose of DTaP The reporter consent to follow up via email. Additional Supportive Information: The patient did not receive full dose of Infanrix vaccine due to malfunction of syringe at age of 12 months, which led to incomplete dose administered, inappropriate age at vaccine administration and syringe issue.
Bouts of vertigo; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 26Mar2021 at 12:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unspecified indication from unknown date. The patient's allergies to food, medications, or other products were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021, the patient experienced bouts of vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event bouts of vertigo was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Admitted on 9/7/2021 with COVID-19 and sever hypoxia. Known COVID contact several days prior. Treated with remdesivir, dexamethasone, ceftriaxone, and azithromycin. Also started on barictnib on 9/9 but stopped due to ARF. Echocardiogram showed EF of 25-50% with moderately severe LV function. Started on heparin and continued throughout hospital stay. DVT in right lower leg. Seen by infectious disease and continued on cefepime and levofloxacin for 14 days. Underwent cryo-amputation of right ischemic lower extremity and then BKA by vascular surgery. Prognosis poor and not improving. Family elected comfort care.
103° temperature, bone aches so bad that it caused me to cry, muscle aches, chills, rash on my injection arm for about 2 weeks that was inflamed and went down to my elbow,, and was lethargic. The 1st dose lasted 4 days with the same symptoms. The second dose had same symptions and lasted 3 days. The booster I has same symptions that lasted 2 days and am still fatigued.
Major loss of smell; Major loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 23Feb2021(at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN); both from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on an unknown date in 2021 at 02:00 as a single dose for COVID-19 immunisation. It was reported that the patient had no allergies to medications, food, or other products. On 27Feb2021 after 4 days, the patient experienced major loss of smell and taste. The patient had no improvement for the events till 12Jul2021. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events loss of smell and taste was not recovered at the time of this report.
Patient presented on morning of 08/31/2022 for 4th dose.  Staff unaware of new protocol from CDC to cease administering booster doses with Moderna vaccine until late afternoon.
Headache, Nausea, Vomiting, Diarrhea, Heaviness in my chest for the past several weeks since getting the first shot.  My symptoms have not subsided.
Patient states a day or two after receiving the vaccine she experienced dizziness, nausea, headache, a sinus infection, and "can't stand on my feet."  The balance issues are continuing to today (12/13/2022).
Erythema on left deltoid at injection site measuring approx. 1 1/2 CM.  Area with increased warmth to the skin.  Pt. C/O some discomfort in the axilla area of the left arm with some swelling there as well.  Benadryl and warm compress to the area and follow-up with MD in 1 week or sooner if area worsens.
having trouble walking however he feels that his legs will get better as the day goes; fever; headache; threw up this morning; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (having trouble walking however he feels that his legs will get better as the day goes), VOMITING (threw up this morning), PYREXIA (fever) and HEADACHE (headache) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concurrent medical conditions included Borderline diabetes. Concomitant products included METFORMIN for Borderline diabetes.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced VOMITING (threw up this morning). On an unknown date, the patient experienced GAIT DISTURBANCE (having trouble walking however he feels that his legs will get better as the day goes), PYREXIA (fever) and HEADACHE (headache). At the time of the report, GAIT DISTURBANCE (having trouble walking however he feels that his legs will get better as the day goes), VOMITING (threw up this morning), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not reported.
1 hour after, soreness at injection site and left armpit. At 3 hours, muscle soreness in neck and muscles along spine (all on injection side- left), hurting most in mid back. Spotty pain in left elbow and knee. 16 hours after, flu like symptoms- aches, chills, body soreness/stiffness. 24 hours after- still feeling like a flu or head cold. almost 48 hours after- left armpit is painful and seems to have a pocket of liquid- puffy, swollen, painful and jiggly. Phone visit with doctor this afternoon.
This spontaneous report as received from a physician refers to a patient of unknown age (gender not specified). On 12-OCT-2012, the patient was inadvertently administered an expired dose of ZOSTAVAX, lot number 671596/1056AA, exp. date 05-OCT-2012 (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Headache, Arthralgia, Fever & NauseaVomiting Narrative: Pt reported Fever, headache, arthralgia, nausea post covid vaccine dose #2. Pt self treated with tylenol.
has a 4 month old that sees a provider in another town that was mistakenly administered Gardasil 9 instead of Prevnar 20 at their 4 month well check; has a 4 month old that sees a provider in another town that was mistakenly administered Gardasil 9 instead of Prevnar 20 at their 4 month well check; No PQC/additional AE reported.; This spontaneous report was received from a physician referring to a 4 month patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On an unknown date, the patient was mistakenly vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not provided) for prophylaxis instead of pneumococcal vaccine conj 20v (crm197)(PREVNAR 20) (strength, dose, dose number, route, anatomical location, lot # and expiration date were not provided) (wrong product administered, product administered to patient of inappropriate age).   No adverse event reported.
UNBEARABLE PAIN FROM MY NECK TO RIGHT ABOVE MY ELBOW ON MY LEFT ARM.
pt recvd vax;devel a 2.5 to 3 inch raised, warm, erythematous area on the arm at the inject site;
patient requested covid bivalent vaccine, but was given monovalent pfizer that expired 9.22.2022
Developed severe headache and hypertensive urgency, resulted in ER visit and having ongoing vertifgo in the aftermath of the event now on 12/17/2021 - we are ordering MRI, suspect possible CVA
PATIENT PASSED OUT WITHIN 5 MINUTES OF RECEIVING THE VACCINE AND WAS OUT FOR APPROXIMATELY 1 MINUTE BEFORE COMING TO.  PATIENT CLAIMS TO HAVE THE SAME THING HAPPEN TO HIM AFTER HAVING BLOOD DRAWN.  PATIENT REMAINED LIEING DOWN FOR APPROXIMATELY 5 MINUTES BEFORE MOVING TO A SITTING POSITION WHERE HE STAYED FOR ABOUT 30 MORE MINUTES.  HE THEN GOT UP AND WALKED AROUND BEFORE CALLING FOR A RIDE HOME.
Extreme vertigo and nausea for 6 days. Could not walk alone. Diarrhea days 6-8. Slight dizziness continued (with movement) until day 12.  Eyes not tracking correctly; double vision when looking to the Right. Double vision at Right continue to present.
2-3 minutes after shots were given, patient fell to the floor, and mom noted shoulder shaking for seconds. Patient was helped to get to examining bed and rested complaining of left leg pain. No known fear of needles nor blood. No vomiting. 30 minutes after patient stood up and went to lab for blood work. Patient referred to neurologist.
Pt. received Pfizer COVID vaccine and went back to work.  Started itching, rash spread over chest, neck and stomach.  Pt. seen by employee clinic, symptoms resolved after given steroid.
Pt came in with wife to the pharmacy to pick up some prescriptions and wanted to show his arm that is still swollen from the vaccine that given back on 05/12/21. When I saw it, the injections site was elevated, red, and looked infected. I told the pt it is possible it got infected and he should get checked out by the dr. His wife said she will take care of getting him checked out by his dr.
Sleepy; Patient mentions she shrunk; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 24 or 29Apr2021 (Batch/Lot Number: EW0170) as dose 1, single and via an unspecified route of administration in left arm on 18May2021 at 10:00 (Batch/Lot Number: EW0185) as dose 2, single for COVID-19 immunisation at pharmacy. Medical history included knee replacement from an unknown date in Aug2018 to an unknown date in Aug2018, gallstones and hysterectomy from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. She spoke with the other agent regarding Detro LA; she will be having a new company for it; and will have to call back to apply with them in Dec2021. She just wanted to say thank you to all the Pfizer agents as everyone has been so nice. Patient mentions she shrunk. Pfizer COVID 19 vaccine; treatment first dose, 24 or 29Apr2021 at 10:00 in the left arm; EW0170. Second dose, 18May2021 at 10:00AM in the left arm; EW0185. She was not sick; but she was a little sleepy; she had no hurting; no nothing; on either one; and no nausea. Caller corrected information, she will get the third dose or booster for the Pfizer COVID 19 vaccine in Jan2022. The events were not resulted in visit of emergency room and physician office. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
TOOK VIVOTIF ON CONSECUTIVE DAYS; This spontaneous case report was received from a pharmacist (PVX2019-184) on 18-Jan-2019. The report describes a 64-year-old adult male consumer who "took Vivotif on consecutive days". The consumer was receiving Vivotif (one dose every other day) for typhoid prevention.  It was reported that the consumer took Vivotif two days in a row and did not skip a day. He picked up the doses on 15-Jan-2019. She was unsure and believed the doses were taken on 16-Jan-2019 and 17-Jan-2019.  The action taken with Vivotif with respect to the event "took Vivotif on consecutive days" was not applicable.  The clinical outcome of the event "took Vivotif on consecutive days" was unknown.  Company's Comment: The causality of the event "took Vivotif on consecutive days" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on consecutive days" was considered as not applicable.