chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician (patient). A 49-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in arm left on 03Feb2021 16:00 (at the age of 49-years-old) as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies reported. Prior to vaccination patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  The patient did not receive any vaccines within four weeks prior to the vaccination and did not receive any vaccines within two weeks prior to the vaccination. On Feb2021, after one shot, the patient had episodic dizziness, alcohol intolerance and mild caffeine intolerance. Adverse event does not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment for the event included aspirin per day. Outcome of event was not recovered.
Information has been received from a health professional concerning a 67 year old female patient. The patient had drug allergies with ZITHROMAX and morphine. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml, lot# not reported, subcutaneous). Concomitant therapies included acyclovir (manufacturer unspecified), SYNTHROID, KLONOPIN, an estrogens patch, progesterone (manufacturer unspecified), testosterone (manufacturer unspecified) and NEXIUM. On 20-JAN-2015, the patient had a titer drawn for immunity to varicella zoster virus, and the titer came back as negative. The patient had been using acyclovir (manufacturer unspecified) (daily for an unspecified reason) at the time she was administered the ZOSTAVAX. There was no treatment given for the event. The patient had not sought medical attention. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin), cetirizine hydrochloride (Zyrtec), omeprazole, rosuvastatin calcium (Rosuvastatin), vitamin d, ubidecarenone (Coq10), fish oil and raloxifene. On 8th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 8th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 9th June 2018, the patient experienced generalized pruritus, erythromacular rash and injection site hives. On an unknown date, the outcome of the injection site pain and injection site hives were recovered/resolved and the outcome of the generalized pruritus and erythromacular rash were not recovered/not resolved.  It was unknown if the reporter considered the injection site pain, generalized pruritus, erythromacular rash and injection site hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported by reporter for herself. The patient was administered SHINGRIX in the left deltoid. One day after receiving vaccination, the patient experienced itching all over body, red dots all over body and hives around injection site. The patient planned to continue follow-up with her physician on an unknown date.
Narrative:  Patient tested positive for COVID-19 and was hospitalized despite full vaccination of Moderna 1&2 but did not receive any booster
diffuse hives on anterior and posterior chest; now confluent.  No wheezing or throat constriction.
lump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (lump at the injection site) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INJECTION SITE MASS (lump at the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INJECTION SITE MASS (lump at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-091836 (Patient Link).
1st Day after injection ran a lower grade fever (100.2),  injection site itching & turning red with moderate pain .  Started taking Benedryl 10 mg and applying 1% cortisone creme ,I buprophen.   Day 2 red rash spreading down arm  5" and about 4" wide.  No fever but site still itiching  & tender.  Continued to treat the discomfort.  The red rash finally fade after 9 days (3/19/2021).  I had delayed reaction to the first injection of Moderna that did not start until 8 days post injection.  Not as sever as the second one.
shingles-like rash on right side of body/rash; This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 4ZF42, expiry date 18th April 2021) for prophylaxis.   On 22nd March 2019, the patient received the 1st dose of Shingrix. On 24th March 2019, 2 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was recovered/resolved.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were reported as follows: The patient developed a shingles like rash on the right side of his body that resolved after 2 weeks.  The patient did not seek medical treatment for the rash.
About 7 minutes after the injection  my upper chest became tight. I went to the nurse and described my symptoms. She gave me a bottle of water and when I took a few sips I noticed that my throat also felt tight.  I was the given 25mg of Benedryl.  My symptoms went away after about 10 minutes.  I stayed for about 35 minutes after I received the injection to make sure I was OK to drive home symptom free.
Pt was waiting required 15 minutes in a chair. After about 8 minutes from receiving vaccine- Pt began to pass out and lose conciousness. Pt could not speak and her eyes began to roll back in her head and her body began to convulse slightly. Administered Epipen to pt in left thigh and she responded immediately. She came to and within a few minutes was able to say her name and count backwards from 10. 911 had been called. paramedics assessed pt. They asked her if she wanted to go to ER and she said yes.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient had panic attack after the dose. She felt numbness and stated it was difficult to walk. She insisted Son (pharmacist) to call emergency number. However, once she was feeling better, Son cancelled the emergency number call. However, later, her husband called emergency number. The firefighters stated ptn is fine as she was feeling better was able to go home with her husband.
Patient reported mild GI distress, redness of face and ears, and feeling like her skin was "on fire". She said she did not know if she had a fever; she was at work and did not have access to a thermometer. But she reported that a co-worker touched her skin and said she felt warm to the touch.
Low grade fever; Bodyaches; Headache; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN, Expiration date:UNKNOWN), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN, Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. On an unspecified date after second dose, the patient experienced low grade fever, it is got an 100.7, body aches, headache. It was reported that patient did not have any problem with first one. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sore/painful left arm 2pm starting on 2/10/21 for 24 hours Felt cold intermittently 4 pm on 2/10/21for 4 hours Skin hypersensitivity 6pm starting on 2/10/21 for 14 hours  Slight headache 6 pm starting on 2/10/21 for 14 hours Fatigue 6pm starting on 2/10/21 for 24 hours
Sensitivity; Taste of soap for about a day; Redness in area; sore arm; This is a spontaneous report from contactable consumers. A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 (Batch/Lot number was not reported) (at the age of 66-years-old) as dose 2, single  for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient has no allergies to medication, food or other products. The patient previously took the first dose of bnt162b2 on 30Jan2021 (at the age of 66-years-old) for COVID-19 immunisation. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. On 20Feb2021, the patient experienced sensitivity, taste of soap for about a day, redness in area and sore arm. The patient did not receive treatment for the events. The events were considered non-serious by the consumer. The patient recovered from taste of soap for about a day in Feb2021, while the remaining events recovered in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diarrhea developing 4-5 days after admin of rota, polio, hib and prevnar vaccines. Duration of 3+ weeks with weight loss necessitating lab work and eventual change to hypoallergenic formula.
<24 HRS. PATIENT REPORTED INCREASED SWELLING AND REDNESS AT THE VACCINATION SITE AND WARM TO TOUCH. ITCHING ALL OVER BODY.  SWELLING DECREASED ON DAY 4, REDNESS TURNED TO PURPLISH.
Chills, body aches, fatigue, lack of alertness, mucus secretion in nasopharynx and upper airways for ~10 days
Pt recv vax on 11/10/98; 4 hr post vax pt exp pain, itch, swelling of LA; fever (99.6); hives on body x 3dy; tx=Benadryl
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 28-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N017698, expiration date: 09-JUN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
Fell forward out of chair and hit head. Transport to hospital , history of epilepsy, allergies to Dilantin. Takes Keppra.
Redness, swelling, soreness with  1 inch by 1 inch yellowish liquid blister located about 1 inch below the injection site.   Not sure when it started exactly but I noticed it this morning and it has increased in size since. I have not seen a doctor for this event.  I have reported it on V-Safe.
Immediate Redness itching at injection site. Pain and burning in arm. Followed by severe flu like symptoms, severe muscle aches and joint pain in entire body,  neck and back pain. insomnia, burning sensation on skin, eyes and throat. Eye pain. Headache. Fatigue. Lightheadedness. Heart palpitations. Fever. Chills.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 03-DEC-2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 20-MAY-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir hydrochloride (VALTREX) and (topiramate (TOPAMAX) for the management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Other than slight soreness at the injection site, I had no noticeable effects from the vaccine for the first 10 days.  Yesterday (January 31st), I noticed for the first time  a redness on my left arm surrounding the injection site.  I had just bathed and the hot water may have made the redness more apparent.  Today when I bathed I again noticed the red patch and took a photo of it, which I will share if requested.   I am reporting this so that you can include this instance in your tracking of "Covid Arm", about which there has been some reporting in USA Today and other newspapers.   Please notify me if you have any recommendations.
I woke and had a fever (26th) - it was 100.5. I had a backache and muscle aches. I slept a lot that day. The next day, I felt okay - just had a slight headache. 28th - I took a nap (unusual for me) for about 3 hours. March 10th - around this date - I started having no energy - tired all the time. I started falling asleep during tv or movies at night. I was taking naps every day. Neither of these are like me, at all. 3/22/2021 - I saw my doctor's PA - I found out that I have elevated blood platelet counts and elevated ferritin. They set me up with a hematologist - I have gone to see her twice now. 1st time: July 12, '21 and diagnosed with elevated platelets (Essential Thrombocythemia) and elevated Ferritin at that time. Was put on medication: Hydrea Oral Capsule 500 mg 1 capsule once/day. Had to use gloves to handle it - and it had hazardous warning with it. 2nd time on August 4th, 2021. I went in to get a blood draw an hour before the visit. The results showed that the numbers were coming down, but they weren't coming down to what it needs to be - increased dosage to 2 on Saturday and 2 on Sunday (continued with 1 on the weekdays). I will see her again on the 9th of this month. Have bloodwork results from 2019 that showed everything was completely normal at that time. I have noticed some improvement - I still usually take a nap about three afternoons a month, if not more. I do fall asleep still sometimes at night with movies - not as often though maybe. I have to pace myself for energy which is just not me and so it's kind of hard. They have taken me off the iron - with the elevated Ferritin. It's never been a problem for me to have these elevated numbers.
VAERS reporting as required by law, death occurred on 01/06/2022. janssen COVID 19 vaccine completed on 3/13/2021..
11 adult patients received the expired Bivalent booster beyond 30 days; No adverse event; 11 adult patients received the expired Bivalent booster beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In January 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In January 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days), PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (11 adult patients received the expired Bivalent booster beyond 30 days) and PRODUCT STORAGE ERROR (11 adult patients received the expired Bivalent booster beyond 30 days).    This case contains information for the 8 out of 11 adult patients described by the reporter. No concomitant information was reported. 11 adult patients received the expired Bivalent booster beyond 30 days in the refrigerator. At this time reporter does not have the patient information handy and reporter was not sure if any of those patients received any other vaccines at the same time. Vaccine vials were a case of 10pcs and 7 vials from the case were used to administer vaccines from 13JAN2023 thru 22JAN2023. Reporter advised that 11 doses of vaccines were used from the 7 vials. Reporter advised that label on case of vials advised that vials should have been used before 12JAN2023 Reporter advised that NONE of the patients that have received the 11 doses have reported any adverse reactions. it was intact cartons, 2.5 ml, The vial was initially stored in the refrigerator 13DEC2022 and administration of vaccine from 13JAN2023 thru 22JAN2023. Vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704253 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704253:Master case  1st adult patient
Initial report received from a healthcare professional on 14 November 2012. A female patient (age not reported) had received a dose intradermal of FLUZONE ID vaccine (lot number and dose number were not reported) in right deltoid on 13 November 2012. The patient's had no illness at the time of vaccination and pre-existing physician-diagnosed allergies, birth defects and medical conditions were not available. The patient's concomitant medications were not reported. On 13 November 2012, after vaccination the patient's right shoulder and whole arm were sore all day after vaccine and now feel fine. Corrective medications and laboratory investigations were not reported. On an unspecified date, the patient's outcome was recovered. Documents held by sender: None.
Patient seen in office on Saturday, July 21st, 2012, after c/o cough for approximately one month. Father with similar symptoms for same amount of time. Parents describe as a whooping cough. Patient vaccinated and up to date on vaccines.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M036296 with expiration date of 14-NOV-2017. Concomitant therapies included sterile diluent (manufacturer unknown). On 17-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Additional information is not expected because there is no consent to contact the reporter. Sender's Comments: US-009507513-1708USA009124.
I had my vaccination 09/14/2022. On 10/10/2022 I started to have blood in stool which turned tarry by 10/14/2023. I started to experience some fatigue. I had a follow up with my physician. I was diagnosed with a GI bleed. Later in 10/2022 and 11/2022 I started to have an increase in fatigue with edema bilaterally in lower extremities. I contacted my physicians office through the portal 11/2023. I contacted them again in 01/2023. I experienced another gastrointestinal bleed on 01/31/2023. I requested for a Cardiology and Gastroenterology consults. I still presently have edema on both lower extremities bilaterally.
1. There were NO REPORTED ADVERSE EVENT.  2. Vaccine was administered at 7 days past the UPDATED EXPIRY of 08/23/21 though still within vaccine PACKAGE EXPIRY date of 08/31/21.  3. Only filing as a VACCINE ADMINISTRATION ERROR report
Information has been received from a registered nurse concerning six patients who were vaccinated with varicella virus vaccine live, 0.5 ml, injection (Oka/Merck) (lot # and route not provided). Subsequently the patients developed chicken pox and had been previously vaccinated. Unspecified medical attention was sought. The patient outcomes were not reported. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Further information has been received from a school nurse who reported that a male patient was vaccinated with varicella virus vaccine live, on 20-FEB-1996. The nurse reported that the patient developed chickenpox. All of the parents and pediatrician felt the cases were mild with minimal missed time at school (approx 2-3 days out sick). Additional information has been requested. This is one of several reports from the same source. Follow up information was received from a registered nurse who reports no further information is available.
Severe headache, racing heart, fever 104 degrees F Healthy athlete who previously had Covid 19 in Fall of 2021.