chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/18/2021 extreme fatigue,worsening joint pain, waves of heat and nausea,hacking dry cough,extreme runny nose,headache,brain fog, started on 3/18/2021 started to end 3/21/2021. 3/21/2021 red, blistering,itchy rash at injection site, lasted one week until 3/28/2021
Case was vaccinated and boosted for Covid as of November 2021, then was hospitalized for Covid in April 2022. Hospitalized at:  Hospital  * Pneumonia due to COVID-19 virus Assessment & Plan Patient with multiple comorbidities including Lewy body dementia who has 24-hour caregivers at home with recent treatment for urinary tract infection who has had several days of subjective fevers and chills at home with decreased p.o. intake, decreased mobility, failure to thrive, weakness. Evaluated in the emergency room and vital signs stable, urinalysis done 1 day prior unremarkable. Chest x-ray was significant for multifocal pneumonia and COVID-19 test was positive. Supportive care recommended. She was initially started on Remdesivir but family elected to transition to comfort care and home with hospice based on her known prior wishes. She was eating little.
Many patients that received their first dose prepandemic and it has been a year or two later that they come in for their second dose.; This case was reported by a physician via sales rep and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (many patients that received their first dose pre-pandemic).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date:19-MAY-2022 Reporter's Comment: The reporter reported that, many patients that received their first dose pre-pandemic and it had been a year or two later that they came in for their second dose.  He would like to know if there was a hard and fast line in the sand where the series needs to be restarted for Shingrix. No additional information available as this was the information received by the sales representative on the healthcare professional's behalf.  HCP's email was provided in the event of follow up but unable to verify HCP's mailing address.
Approximately 2 weeks after my 2nd booster (4th dose vaccination) I experienced the following symptoms: Headache (Constant headache). I took Tylenol (Extra strength), Tylenol Dual, it would lessen the pain but it did not do anything to make the headache go away. I saw my primary care who advised me to get a CT Scan and the result was normal. I was given an IV medication of electrolyte, and prescribed with Toradol and Reglan. As of today 04/19/2022 my headache isn't as severe and the pain is tolerable.
No adverse effect besides soreness on injection site right after the vaccine for the 2nd booster shot. Same reactions with the First two shots and 1st booster shot.   2 weeks after the second booster. Itching hands and feet. Scratching resulted in hives, welts, redness. Was able materials like handles of Tote bags that were scratchy would result in redness and or bumps/raised skin. Was able to scratch skin spelling out my name and I could write on my skin. Would disappear after about 30 min. Self diagnosed it to be Dermatographia. I?ve never been a person that experiences allergic reactions to foods or vaccines before. Went to see my GP and he agreed with my self diagnosis as Dermatographia appeared exactly two weeks after my second Pfizer booster shot.
MMR given 8/1/14. Varicella given 8/21/14.
sick; chest pain; tired; body aches all over; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), CHEST PAIN (chest pain), FATIGUE (tired) and MYALGIA (body aches all over) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ILLNESS (sick), CHEST PAIN (chest pain), FATIGUE (tired) and MYALGIA (body aches all over). On 18-Feb-2021, FATIGUE (tired) outcome was unknown. At the time of the report, ILLNESS (sick), CHEST PAIN (chest pain) and MYALGIA (body aches all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were  provided by Reporter. No treatment Medications were  provided by Reporter.
Patient wanted to receive first dose of Pfizer vaccine, which was misplaced with Janssen vial after puncture. 0.3 ml of Janssen COVID-19 vaccine was drawn up and administered to patient. Patient was offered remainder of dose (0.2 ml) but refused.
Possible adverse events from receiving the vaccines: INFLUENZA, MMR, varicella and PREVNAR 13. Pt. developed 6th optic nerve palsy affecting (L) eye. Pt. received the above vaccines on 12-9-11.
received the Johnson and Johnson vaccine against covid-19 in march 2021.  Person began having symptoms of covid on 08/07/2021 and tested positive on 08/10/2021.  She had fever, chills, loss of smell, cough and body aches.
12:45 sweating 168/98 12:55, 1148/96 1:00, 140/96 1:05, 146/90 1:15 feels dazed;sl stiff neck, throat thickening, vision feels not quite right, h/a;sx for 3 days weakness, tired, not feeling well;
severe headache, nasal congestion, dizziness, tiredness all lasting 3 days
The EE fully vaccinated with Pfizer on 01/6/21 and 01/27/21, became symptomatic on 07/12/21 and tested Positive on 7/16/21. Denies any work or community exposure. However son also symptomatic and will be tested as soon as possible.
About 10 days following 3nd vaccination, I felt a strangely ominous burning ache in a larger region of my left shoulder; the pain increased with arm movement, but dissipated within about 1/3 to 1/2 minute.  There have been at least 4-6 similar events, usually somewhat longer, since that first concerning event.
First shot arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (First shot arm pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MYALGIA (First shot arm pain). On 15-Mar-2021, MYALGIA (First shot arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported .
I have been testing positive for Covid for over a month even though I had the vaccines and a booster; I have been testing positive for Covid for over a month even though I had the vaccines and a booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have been testing positive for Covid for over a month even though I had the vaccines and a booster". Clinical course: Patient takes tofacitininb citrate (XELJANZ). Patient has been testing positive for Covid for over a month even though patient had the vaccines and a booster. Asked if we have similar results from patients taking Xeljanz. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: testing positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 11/26/2022, I inadvertently gave patient Flucelvax instead of Moderna Bivalent Booster. Patient had already received one dose of Flucelvax for the 2022-2023 season on 10/08/2022.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-MAR-2015, the patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose: the prevention of shingles. As a direct result of the ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of her body. The patient's shingles outbreak was diagnosed on 01-SEP-2015. As a direct result of the ZOSTAVAX, the patient suffered mental and emotional distress due to and continues with physical limitations and seriousness of her condition. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use her use of  ZOSTAVAX. Shingles outbreak was considered to be disabling. Additional information has been requested.
Fever(102.0F), redness, swelling at injection site. Stiffness and soreness localized to Rt upper deltoid.
Patient developed 14 hives 15 minutes within receiving Varivax, Pedvax Hib, MMR, Fluzone & PCV13.  Patient was given Benadryl and observed for 30 minutes.  Hives were gone within 10 minutes of giving Benadryl. Patient to follow-up with Allergist.
Starting on 04/06/2021, I noticed my lymph nodes were swollen underneath my arm. I had breast tenderness and leakage out of the left breast. I called my PCP and they wanted to see me. They sent me to get a mammogram and another evaluation like an ultrasound, which both came back indicating swelling. The lady who performed the mammogram indicated to me it was a common side effect after the vaccine. I did not follow up with my PCP again until I developed Shingles not to long afterwards. Since the case was mild, they did not give me anything for treatment. It resolved on its own in 14 days.
Reports extreme pain with injection, muscle weakness, loss of range of motion in left arm causing limitation with activities. Ibuprofen taken with minimal relief. Pain waking her up from sleep. Continues to have the same pain level on 3/28/08 as she did when 1st vaccinated. Did not see her doctor. Tetanus give 1 month early in left arm, pain lasted only 2-3 days.
My eyes turned light red one more darker than the other. It is now day 3 and it has gotten darker to a dark purple; Where the rash is it is very sensitive and itchy; My eyes burn from time to time; This is a spontaneous report received from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Mar2021 (age at vaccination unspecified) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. As per the verbatim, the patient got Pfizer covid vaccine on Thursday 04Mar2021. On an unspecified date in Mar2021, the patient woke up the day after and under my eyes turned light red one more darker than the other. It was now day 3 and it has gotten darker to a dark purple. Patient never had a reaction to any medicine before. Where the rash is it is very sensitive and itchy and eyes burn from time to time. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
1 week after 2nd vaccine, a rash developed on lower rt leg. Thinking it was topical ( Poison Oak etc...) I watched. over 2 weeks it worsened. I took a photo and sent to Dr on April 29. April 30 dr said eczema - use Triamcinoline as prescribed. I filled and began applying 5/6. By 5/7 rash was on all limbs and torso.
Pt has c/o numbness to the injection site, with redness to the lower arm. Pt was brought to the ER for further evaluation.
COVID-19; COVID-19; vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 at 09:00 as dose 1, single (Lot number: El3247), in left arm, on 08Apr2021 at 09:00 as dose 2, single (Lot number: Ew0151), in left arm and on 06Nov2021 at 12:00 as dose 3 (booster), single (Lot number: 320308d) at the age of 64 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 056m21a), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Apr2022, outcome "unknown", described as "vaccine brand other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (18Oct2022) Negative, notes: a negative test on 18Oct2022; (28Oct2022) Positive, notes: Tested positive with symptoms 10 days after last dose of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid from 13Oct2022 to 18Oct2022 for treatment of COVID-19. Paxlovid rebound. Patient was tested positive with symptoms 10 days after last dose of Paxlovid and a negative test on 18Oct2022. Event did not resulted in emergency room visit or physician office visit. No treatment received for Paxlovid rebound. No known allergies.
Chest pain in center of chest along with sternum popping; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sour cream and certain pain killers. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included birth control received within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 09Apr2021 at 11:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 03May2021, the patient experienced chest pain in center of chest along with sternum popping. The event had not resulted in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of event chest pain in center of chest along with sternum popping was not resolved at the time of this report.
Intranasal H1N1 vaccine given to 22 month old child. No symptoms of reaction occurred prior to client leaving clinic.
1st day after having vaccines, day long headache and nausea and no medicine taken helped. Had to miss work. 2nd day better but later in the day had a migraine. 3rd day dull ache and very cloudy feeling.
She woke up with dry Cough and wheezing the morning following he FluMist.  By the next day she had a barking cough and wheezing.
12 hours after receiving the booster, I developed fever of 101 and chills for 2 days as well as body aches.
S/p injection, pt was being in for med about shot; pt ready to leave and all of a sudden slumped in chair, his head drooped to the left, she snored briefly with his eyes open. His wife assisted, asked him to sit up, he struggled then went rigid and briefly seized. Went to ER via EMTs.
Fever 101, vomiting, headache, swollen, tender injection site and upper arm.
Fever, whole body ache - hurt to move, constant pounding headache, red eyes, chills.  Arm where shot was given was very sore even to move it slightly.  Lasted for approximately 24 hours.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 15-Apr-2021 at 11:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:55 AM, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.79.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively,  9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion; On 21Feb he went to the ER after vomiting and passing out; On 21Feb he went to the ER after vomiting and passing out; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; On 19Feb, he began to feel ill again with a fever. He felt worse on 20Feb; fever; headache; stomach upset; This is a spontaneous report from a contactable consumer reporting for the father:  A 75-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EL3428) at single dose at left arm on 03Feb2021 for Covid-19 immunisation. Medical history included type 2 diabetes mellitus. No known allergies. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included amitriptyline hydrochloride (manufacturer unknown) 10 mg, atorvastatin (manufacturer unknown) 20 mg, dutasteride (manufacturer unknown) 0.5 mg, linaclotide (LINZESS) 290 mcg, gabapentin (manufacturer unknown) 300 mg, montelukast (manufacturer unknown) 10 mg, ramipril (manufacturer unknown) 5 mg, insulin degludec (TRESIBA) 100 unit/ml, liraglutide (VICTOZA) 18 mg/3ml solution. No other vaccine in 4 weeks. The patient experienced cardiac arrest due to pericardial effusion on 21Feb2021 14:15, fever on 13Feb2021, headache on 13Feb2021, stomach upset on 13Feb2021, on 19feb, he began to feel ill again with a fever, he felt worse on 20feb on 19Feb2021, on 21feb he went to the ER after vomiting and passing out on 21Feb2021.  Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of cardiac arrest due to pericardial effusion.  Course of events: In Feb2021, 10 days after his 1st injection, the patient developed fever, headache, and stomach upset. He went for a rapid Covid-19 test (nasal swab) and it was negative on 11Feb2021. The doctor told him he might be having a delayed reaction to the vaccination. After a couple of days, he improved. On 19Feb2021, he began to feel ill again with a fever. He felt worse on 20Feb2021. On 21Feb2021 he went to the ER after vomiting and passing out and received treatment: IV fluids, diagnostic testing at ER. Rapid Covid test (nasal swab) at ER came back negative again on 21Feb2021. His heart arrested suddenly and he could not be resuscitated. CT scan results, that came back after death, showed Covid like pneumonia and pericardial effusion. The patient died on 21Feb2021 14:15. Cause of death was cardiac arrest due to pericardial effusion. An autopsy was not performed. The outcome of cardiac arrest due to pericardial effusion was fatal, of fever, headache, stomach upset was recovering, of he began to feel ill again with a fever, he felt worse was not recovered, of he went to the ER after vomiting and passing out was unknown.; Reported Cause(s) of Death: cardiac arrest due to pericardial effusion; cardiac arrest due to pericardial effusion
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 40-year-old male. Neither medical history nor concomitant medication were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flue season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and included patient demographics. Additional information was received on 12-May-2009: product complaint investigation results.