chrisvoncsefalvay/vaers-outcomes huggingface dataset:
75-100 papulovesicular lesions (dew drop on rose petal appearance, 1-4mm) scattered over anterior trunk, less so on back and proximal arms; no crusting of lesions and no sign of secondary bacterial infection. Rec: topical anti-itch creams (non benadryl and non steroid containing); Aveeno baths prn; Rx Acyclovir 200mg/5ml, 2 tsp po qid x 10 days.
10 weeks pregnant, due October 1. Chills, fatigue, stiff joints, injection site pain.
SORE WITHIN FEW HOURS. FEVER. CHILLS. SWEATING. CHILLS. DIARRHEA. ARM IMMOBILE. SEVERE UPPER ARM SWELLING. ERYTHEMA. HOT. GOT STEROID INJECTION IN ER. PT STARTED ON CLINDAMYCIN, IBUPROFEN & ONDANSETRON BY MOUTH.
Initial misuse report received from a healthcare professional on 06 August 2013. A patient (No information was provided regarding the patient) received an expired dose of MENACTRA. No adverse event was reported. List of documents held by sender: none.
1st dose my glands had some swelling; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration, administered in Arm Left on 06Jan2021 14:45 as single dose for covid-19 immunisation at Hospital. Medical history included, drug hypersensitivity (Allergies: Penicillin) from an unknown date and unknown if ongoing. Concomitant medication included esomeprazole sodium (NEXIUM) and ibuprofen. The patient previously took amoxicillin, codeine and experienced hypersensitivity. The patient reported 1st dose my glands had some swelling on an unspecified date. The action taken in response to the event for BNT162B2 was not applicable. Therapeutic measures were taken as a result of 1st dose my glands had some swelling (lymphadenopathy). The outcome of event was recovered.
2-3 weeks later had bruising on the chin and it was numb just for a couple of days. 3-4 days later felt like bruising on left ear and it was also itchy.
4 days of Severe headache, nausea, neck pain, no tolerance to bright light.  Still having all symptoms.  I have had  aseptic meningitis in the past and this reminds of that.  I am not a doctor so I don't know.
The child had an undiagnosed metabolic/endocrine problem had gradual deterioration in the last few months of life. A week before death the pt had a "strange" breathing pattern, like gasping. Died 15 days post vax. PMD does not think it is causally related. Sudden death, no fever.
I administered first dose of Pfizer covid 19 0.3 ml via intramuscular route to this patient. About 2 minutes after the administration, the patient had syncope for a second. When I arrived to the scene, the patient was conscious. When he passed out, he felt and landed on his head. He had an abrasion. He stated ?he felt hot and dizzy?. He hasn?t had anything to eat all day. Due to the abrasion, he was rushed to the hospital  About 3 hours later, I called to check on the patient. At the time of calling, the patient was discharged from the hospital in good condition. He stated he felt perfectly ok and wasn?t sure what had happened.
Patient received FLUZONE (High Dose) on 10/17/12 & on 10/19/12 woke up with body rash & swollen face & had gone to her primary doctor to be evaluated. Patient follow up is that she is doing fine. Dr. recommended to patient to take BENADRYL. I called pt on 10/29 and she is fine.
Patient was vaccinated with first dose in another place and then came here for the second dose, patient received the first dose of MODERNA in another place and the PFIZER vaccine was administered by mistake.
swelling of both upper & lower eyelids rt eye;mild h/a;no itching or wheezing;no chest pain;no hives;no difficulty in swallowing or breathing;
pt recv vax 14OCT96 & c/o of soreness in rt arm which was cont across to back & lt arm;pt was seen by MD;CXR negative;pt has not yet recovered;rt shoulder discomfort, especially worse @ noc;tendonitis;
I95.9 HYPOTENSION 8/29/2022 DIVERTICULITIS I95.9 HYPOTENSION 8/29/2022 DIVERTICULAR ABSCESS
Received its 30-days Exp date; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT CLOSURE ISSUE (Received its 30-days Exp date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022 at 2:32 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jan-2022 at 2:32 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT CLOSURE ISSUE (Received its 30-days Exp date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT CLOSURE ISSUE (Received its 30-days Exp date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity.  No concomitant medication was reported by reporter.  Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. Dose was given at 24-Jan-2022 14:32:43.  No treatment medication was reported by reporter.
Severe unprovoked anxiety Severe mood swings Inability to sleep for more than 4 hrs
1 1/2 to 2 hours after vaccines administered patient came to clinic and reported itching "all over". No wheals seen. No redness or swelling at injection sites. Diphenhydramine 25 mg po given with relief of itching. Pt had eaten lunch between injections and itching.
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial had not underwent temperature excursion. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
High blood pressure. Chest tightness, left arm pain Gassy feeling. Cardiac work up done at Emergency room. Stress test and Echocardiogram done by the Cardiologist.
Booster dose given at less than 6 months after initial series; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose given at less than 6 months after initial series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.
I received my second covid shot on 12/29/2021. I took Ibuprofen before i got the shot and before going to bed. I woke up 12/30/2021 with a sore arm in injection site. I took a dose of Ibuprofen in the morning before work but otherwise felt good. I noticed around 12pm my left cheek was sore, no jam pain just sore. I noticed at 1pm that my face was completely red and has a rash. It is a little hot to the touch and the rash isn't raised. I also noticed I am starting to have a headache and took some ibuprofen I notified my jobs employee health who recommended I do an anywhere care visit. That doctor suggested I take some anti-histamine and report this reaction.
Very swollen and feverish with bumpy feel to surface. Larger than a golf ball and very hard. Did not appear until 14 hrs. later. Got worse over three days and ice was used nearly constantly. Also took anti-inflammatory. No visible effect. Began hurting on second day after onset. Blisters have not formed yet. Ongoing today 07/15/2013.
Second shot had pain in extremities and very tired and weak for 24 hours. Felt like flu.  Six months after 1st shot in ER for unexplained racing heart. Feb 2022 November 2022 back in ER for unexplained racing heart rate and high blood pressure
This report is regarding the Pfizer COVID-19 vaccination received (batch/lot# FD0809). Pfizer and other regulatory agencies determined the dose of vaccine the patient received is valid.
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-MAY-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K026385, expiration date 15-DEC-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Patient stated that within a week of receiving the vaccines, his right arm developed muscular pain that worsens at night if he sleeps on that arm. This has continued for the last 3 months with no improvement and he is unable to sleep with his weight on that side anymore.
On the morning of 4/23 around 12:30am, I began to develop flu-like symptoms; Body aches; Fever; Chills; Mild headache; I had terrible joint pain as well in my elbows, wrists, ankles, and my knees. It was most severe in my knees. They throbbed consistently.; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 22Apr2021 at 11:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included kawasaki's disease in 2002, latex allergy, allergy to nickel and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included fluoxetine (MANUFACTURER UNKNOWN) and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN); both for unknown indicatiion on unknown date and unknown if ongoing. The patient previously took cefaclor (CECLOR) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 13:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On the morning of 23Apr2021 around 00:30, the patient began to develop flu-like symptoms. The patient had body aches, fever, chills and a mild headache. The patient had terrible joint pain as well in her elbows, wrists, ankles, and her knees. It was most severe in her knees. They throbbed consistently. It hurt to stand. Her symptoms continued for about 36 hours. The patient no longer had them. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL), which somewhat alleviated her symptoms. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events began to develop flu-like symptoms; had body aches, fever, chills and a mild headache; had terrible joint pain as well in her elbows, wrists, ankles, and her knees; it was most severe in her knees; they throbbed consistently; it hurt to stand. Her symptoms continued for about 36 hours was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
I did not noticed anything on 03/30/22 after getting my vaccine. On April 3, 2022 I went to the emergency room. My blood pressure was starting to get high. I measure my blood pressure regularly. I did not have any sick symptoms just the high blood pressure. The doctor at the emergency room stated that he thought it would be related to the booster shot. The doctor did give me a pill at the ER. It brought my blood pressure down in about 30 minutes and I was sent back home.
left arm was tender for 2 days after the injection with no markings.  After 10 days my left arm became tender again and a red patch appeared the size 1" x2" at the injection site.
Pain at injection site, headache, fever, very loose stools,  body aches, chills, extremely tired. I was asleep by 6:00pm and slept through the night until alarm went off at 6:30AM. Symptoms were very similar to when I had COVID in January for 3 weeks but just less severe.  Today I feel just a slight headache but overall feel good.
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 10-year-old female patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 01-MAR-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
high VZV IGG titer greater than 4,000; Shingles infection related to a vaccine/positive VZV PCR; This spontaneous report was received from a manager, referring to a 17-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.    The patient was vaccinated in February 2003 and in October 2006 with an unspecified vaccine which may have been varicella virus vaccine live (oka/merck)(VARIVAX) but could not confirmed (reporter assumed that the patient had vaccinated with Merck vaccine) for prophylaxis (strength, dose, frequency, route, lot number and expiry date were not reported).   On 24-NOV-2019, the patient had appeared to be shingles infection (herpes zoster) related to vaccine. On 24-NOV-2019, the patient had high VZV IGG (varicella zoster virus, immunoglobulin G) titer greater than 4000 (unit not reported) (viral titre increased), positive VZV PCR (polymerase chain reaction) from scrapping and IGM (immunoglobulin M) titer was still pending. The patient sought medical attention. No product quality complaint (PQC) was involved.     The outcome of herpes zoster, varicella virus test positive and viral titre increased was unknown. The causality assessment between varicella virus vaccine live (oka/merck)(VARIVAX) and shingles infection was related. The causality assessment between varicella virus vaccine live (oka/merck)(VARIVAX) and viral titre increased was not reported.
A non-serious report of influenza was received from a consumer concerning a child of unknown age and gender.  This case is submitted in accordance with a companies post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No relevant medical or drug history information was reported.  The child was given FluMist in November 2007.  The patient developed influenza infection in February 2008.  No outcome for the event was provided by the reporter.  Rechallenge is not applicable.  The reporter did not provide a statement of causality to FluMist.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
PATIENT UPPER LIP BEGAN SWELLING AND FEELING painful. She 1 tablet of Benadryl 25mg on sat 9/28 and Monday morning 9/30. She called pharmacy at 2:30 pm on 9/30 to report event. The swelling and pain are subsiding and she feels much better.
Patient started to look jaundice on the night of May 29th. Brought him to PCP on the 30th where he vomited, PCP stated his red blood cells were breaking down and to bring to ER. At this time patient was asleep and basically had no movement, extremely dehydrated. Once we got to the ER, doctors/nurses tried to get blood and confirmed his HGB was at a 3. He was given a blood transfusion, his HGB went up to a 5 so he was given another blood transfusion and his HGB went up to a 7.9. Over the next several days he was being monitored and was given a high dose of methylprednisolone. On June 1st his HGB went down to a 6.3 so he was given another blood transfusion with his blood type A+, his HGB went up to a 11.4. tested once per day. We were discharged on June 7th. He has been on prednisolone twice daily starting at 2.3ml and currently now taking 1.1ml twice daily. His steroids have been weaning weekly up until Aug 15th. He received his 6 month vaccines on Aug 8th and since then his HGB has dropped to a 10.8 on Aug 16th and is a 10.8 as of Aug 22. Diagnosis is Autoimmune Hemolytic Anemia
I am currently active male 58 yrs old. Before the 2nd shot I was able to run, swim and ride bycicle (all racing) without any disconfort. After the 2nd shot( same week)  I started experiencing chest pressure or pain, short of breath and tireness during my training sessions. During my running training I most stop because I feel a pressure in my chest. If I stop the pressure disappears, until I resume again it comes once again.  Finally I am able to finish my training feeling very tire and without energy. I had recently a EKG and echocardiogram and everything was normal per my Doctor's statement.
Information has been received from a physician concerning a female patient who in November 2009, was vaccinated with the first dose of GARDASIL (lot number not provided). In February 2010, the patient was vaccinated with the second dose of GARDASIL (lot number not provided). The physician reported that in February 2010 the patient experienced nausea, diarrhea and generalized body aching after receiving the second dose of GARDASIL. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. No further information is available.
Moderna COVID-19 Vaccine EUA   Redness, swelling and pain at the injection site. Was most painful and swollen on the day following the injection. The pain and redness lessened each day without any interaction. By the 4th day following the injection, the injection site is still slightly red  with a very small bit of pain when touching it.
After each vaccine I experienced mild flushing of the chest, neck and face for about 30 min after the vaccine. Once it resolved, they cleared me to go. 12 hours later, I developed a fever of 101, body chills, extreme nausea, diarrhea, headache and other flu-like symptoms. I was extremely fatigued to the point where I was unable to get up and ended up being in bed for about 3 days. It increased my POTS symptoms (heart palpitations, dizziness and presyncope). I called the doctor to see if I should be taking medicine or not to treat the symptoms and I was told to treat my symptoms as if I was in a POTS flare (fluids, tylenol and legs elevated above heart). Also, I was told to continue the normal medicine regimen and to take the cannabis as needed. The fatigue and body aches lasted for a full week. The fever only lasted for about a few days.
Within weeks my special needs son started having memory issues and concentration issues. He went from a vibrant, social, young man to a sullen, moody individual who couldn't get out of bed.  He then started  having pica issues that increased as time went on. It wasn't until psychiatric hospitalizations with no improvement led me to insist that his iron levels be taken because of the pica. It was found that his iron number were off.  He also became very rigid and displayed full body inflammation.
My arm was very sore the day of the vaccine, which was very different as I had no soreness or any issues with the first two shots. The next morning I woke up very early as the soreness and pain in my upper left arm was keeping me from sleeping. I wasn't able to raise my arm more than a few inches. I know they say be sore for two or three days, but it wasn't any better so I called my doctor on Monday. My doctor prescribed me an oral steroid and I am just finishing that today. I still do not have full range of motion in my left arm and there is still discomfort.
7/19/21 Spoke with patient. Patient was exposed to a unknown source. Patient is FULLY vaccinated and states she was masked the entire time. Patient has not been to work for two weeks. Patient was tested 7/18 when patient arrived into (Privacy). Patient is sx (7/16): cough, diarrhea, fever & loss of taste. Patient understands to be out 10 days and sx free/improved for 24 hours. Patient will call for clearance. Patient understands to be out 10 days and sx free/improved for 24 hours. Patient will call for clearance.
Person was vaccinated 5 days prior to the 28 days for the second dose of the Moderna vaccine.