chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jynneos administered intramuscularly; Case reference number US-BN-2022-001698 is a spontaneous case report initially received on 27-Jul-2022 from a health care professional (reference number: USBAV22-0690) and concerns a *34-years-old male patient*.  The patient's medical history and concomitant medication details were not reported.  On *13-07-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), intramuscularly (IM), at a dose of 0.5 mL, at *right deltoid* for pre-exposure prophylaxis (PrEP) (explicitly coded as Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.   At the time of this report, it was known that the patient did not experience any adverse events due to the Jynneos vaccination.  This case is linked with case no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from Bavarian Nordic on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from a healthcare professional via Bavarian Nordic on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 34-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at right deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 34-year-old male patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, at right deltoid, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Patient received hepatitis a, typhoid and yellow fever vaccines.  Within 20 minutes of receiving shots, patient complained of burning sensation on her face to the billing clerk but only reported numbness and tingling on both sides of her face to the nurses responding.  Vital signs stable.  Patient alert and oriented without any other complaints.  Rescue squad called.  Patient elected to drive self to clinic.  Called patient 8/4.  She said she received epinephrine and prednisone at clinic.  Patient says when she woke up this morning she felt fine without any numbness or tingling in her face.
Immediate severe dizziness, lightheaded, weakness, couldn?t stand, turned pale. Had to sit down and wait 20 minutes before I could leave the store. Felt weak and general malaise for 24 hours.
A nurse did a double dose (1ml) in error; A spontaneous report was received from a nurse, concerning a 49-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced inappropriate dose administration.  There were no medical history and concomitant medications reported.  On 06 Jan 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient received a double dose (1ml) of the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, "inappropriate dose administered" was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 49-year-old, male patient who received their first of two planned doses of mRNA-1273 (Lot Number: 025L20A), reporting Incorrect dose administered.
Diagnosed with 2 blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Diagnosed with 2 blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Diagnosed with 2 blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Diagnosed with 2 blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
DTaP and HIB vaccines both administered IM to R anteriolateral thigh on 10/31/02. Child woke next am with generally swollen R thigh and unable to bear weight. No redness, did not feel indurated, non-tender, and there was no redness or increased swelling directly at either injection site. Tx: Motrin, warmth. Temp 99.2 degrees. 11/4/02 bearing weight by late 11/1/02; swelling much less.
Information has been received from a physician's assistant concerning a 52 year old patient with chronic obstructive pulmonary disease and allergy to VIOXX, who on 17-MAR-2011 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667271/0880Z EXP 11-DEC-2011) IM. Concomitant therapy included bupropion HCl, hydrochlorothiazide, cyclobenzaprine HCl, acetaminophen/hydrocodone bitartrate, lisinopril (manufacturer unknown), omeprazole, PROAIR and promethazine. The physician's assistant reported that the patient experienced severe local reactions, after receiving PNEUMOVAX 23. Patient's whole arm was swollen and she felt so much pain that she took VICODIN she had at home but did not get any pain relief. The patient could not sleep at all due to severe pain. There were not Lab diagnosis/studies performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
High fever runny nose coughing and rash on neck and face ear infection throat infection and further rash break crying vomiting.
Patient was given a Moderna Vaccine on 1/26/2022 by one of the clinics LPNs.  He was 16 years of age at the time of the vaccine.  I was made aware of the event today .  Called Mother today to inform her that the Moderna Vaccine is indicated for 18 years and older.  She states that he had numbness to the injection site right after the injection.   He has been feeling fine, no symptoms.
now shingles has become a part of pain; now shingles has become a part of pain; rash on left side y ribs and under left breast.; Suspected vaccination failure; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (received now Olumiant for three weeks). Concomitant products included baricitinib (Olumiant).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and rash. On an unknown date, the outcome of the vaccination failure, shingles, pain and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and rash to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Olumiant for three weeks for rheumatoid arthritis.  The patient reported now the patient had shingles. The patient had all the vaccines but now shingles had become a part of pain and rash on left side of ribs and under left breast. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Patient came with her daughter to the pharmacy and stated that her upper arm has been having long lasting pain since the last moderna booster. The pain started 1 day after the injection. The injection site was warm to touch and tenderness after the shot but went away, but the pain has been lasting. Patient had seen by PCP and recommended massage and pain relief cream/lotion. Her pain was relieved with massage but came back next day.
intermittent bilateral peripheralal neuropathy in hands and feet Narrative:  Per his PCP "He described intermittent numbness, tingling, which is sometimes painful, involving fingertips and toes. Sx are most prominent when driving or in bed preparing to sleep. He consulted his PCP, who is an NP. She checked HbA1c and found it normal. She prescribed gabapentin 100mg daily prn, which patient has not used. There were no reports of peripheral neuropathy in the FDA documents for the Pfizer vaccine. Intermittent symptoms are unusual for peripheral neuropathy. Hyperventilation can cause intermittent numbness and tingling of fingers and toes.At this time I would characterize his symptoms as unexplained. Although it is unlikely, I cannot rule out a relationship to the vaccine. Due to concern that the symptoms could be an early symptom of a neurologic condition that has not yet fully manifested, I advised him to cancel his appt for the second dose, and wait to see how if his symptoms progress. If his symptoms resolve, he could schedule the second dose of vaccine at a later date. While the 21 day interval is ideal, CDC has advised that there is no outer limit to when the second dose may be administered."
pt recv vax 1996 & 18MAY97 pt devel a rash that consisted of greater than 50 lesions on legs & feet & foot pain;
10 year old clinic received HPV9 at off site clinic, at 11:00am. Client reported feeling dizzy immediately after administration. Client lowered head between knees, given soda and cold compress. At 11:16 am, issue unresolved. Referred to paramedics on site. Paramedic assessed client, O2 given, and fully recovered by 11:30 am.
The night of the injection, She began to get a few hives on her mid body. They still remain and are continuing to move upward on her body including in the armpit. Maybe 30 or 40 red spots total.  No other symptoms or problems at this time.
Client c/o dizziness and weakness about an hour after Moderna booster dose administered. Denied difficulty breathing or chest pain. Blood pressure and pulse normal. EMS called and client transported to hospital for evaluation. Client with multiple health conditions and medications.
Second shot gave me terrible side effects. In addition to nausea, vomiting and diarrhea, I had very strong and painful stomach cramps and pain for about 12 hours, that made it difficult for me to walk around.
LEFT DELTOID REGION WITH SWELLING & ERYTHEMA 6CM X 5CM AT IMMUN SITE TO DTaP.
This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered an unspecified number of improperly stored doses of GARDASIL (lot # L020162, expiration date 23-JUL-2017) (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 32 F for 2 hours and 8 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had Covid in Dec 2020. About 24 after shot I experienced symptoms that were far worse than my experience with Covid. I did not have a fever with Covid,  a day after the shot I had a fever of 103.1, I have not ran a fever in 15-20 years.
Site: Redness at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Seizure-Medium, Systemic: Shakiness-Medium
Parents report bruising & hematoma at site of inject, /w fever 102 F, Pt unable to move leg too much pain (avoided moving). Erythema over site. Waited until next day to be seen at office, leg quite improved by hx, so declined to come in.
After 24 hours I developed a rash that was spreading and a lot of heat, tenderness and swelling. That  lasted about three days, most went away except the tenderness. Then at ten day mark all symptoms came back.  I did speak to a Dr. and they suggested I take Benadryl, put ice and outline it to see if it was growing.  It took about two days to go away.
Dad reports sycope with vaceine administration.   lesions around ankles. Developed 1 small hive on L ankle over the next week more lesions appeared around ankles. Lesions began to widen and dusky purplish center appeared. Monitor and return if sx worsen.
Patient is 15 years old and was given the Moderna vaccine which is not year approved for his age group.
Booster dose of the Pfizer Covid vaccine; Watery eye; Burning sensation; Her dry eyes is much better and she is experiencing tears; This is a spontaneous report from a contactable consumer, the patient. A 69-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number: 30145BA), via an unspecified route of administration on 12Oct2021 as dose 3 (booster), single for covid-19 immunization. Medical history included bone dry eyes, conjunctivitis, rosea, all in her eyes severely for the last 4 years, and not as severe issues before that. The patient concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6202), via unspecified route of administration on 24Feb2021 as dose 1, single and dose 2 via unspecified route of administration on 17Mar2021 (Lot number: Lot: ER8727 or EC8727) as dose 2, single both taken for covid-19 immunization. It was reported that the patient received the booster dose of the Pfizer Covid vaccine 2 to 3 weeks ago and was reported a positive side effect. After the booster dose last month, she noticed she was at work and noticed she had not put drops in and the afternoon would go by and she did not need the drops. In the past she would have to stop working and put her drops in her eyes in the afternoon. Stated that dry eyes were so painful, and she would be watched to see what happened with her eye. Her eyes felt good and if she could help someone by reporting this. The patient had severe dry eye condition, where it was very itchy. The only reaction patient ever had to the vaccine was watery eyes, a burning sensation, nothing else, patient felt that was probably where her inflammation was from in 2021. The patient went to her eye doctor for which he had been treated her for years, and said her dry eyes, her condition was controlled. The patient wondered if the vaccine had an effect on it, because patient used everything, 5 kinds of eye drops, and now she had down to over the counter as of yesterday, and wanted to pass it along, that if there was something in the Pfizer shot that caused that. The patient did not usually have tears, and runny nose after the shot but hardly nothing else, and that was not usually associated with dry eyes. So many people had dry eyes, and she never of it getting better. The patient stated if there was something in the vaccine that helps with dry eyes, she wanted to report this. The outcome of the events was unknown.  Follow-up attempts were completed. No further information was expected.
Attendee received first dose Pfizer vaccine at 7:05am in the Left arm.  Attendee made 2nd Vaccination appointment. At 7:08am wife called out, Patient in chair with head back. Said he felt light headed and dizzy. Maybe lost consciousness. Staff assisted him to floor and elevated his legs with knees bent. During this exchange, Attendee regained consciousness. 7:20am V/S B/P 136/72, T-35.9C, 02 97%, Pulse 95. Paramedics assessed. Assisted Attendee into a wheelchair and taken to a private area. Monitored and released.7:45pm - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with their spouse.
approx 2yrs p/vax pt broke out w/varicella & was seen by MD. 29oct pt devel fever & had widespread pustules. full blown case over entire body
1 day p/vax in lt deltoid pt had confluent urticaria over lt axilla, lt chest & side (10" X 10" area);
Breakthrough case admission after 4 vaccines Moderna 1/22/21 lot# NONE; THIS LOT # IS NOT AVAILABLE IN THE DATABASE Moderna 2/19/21 Lot# 043L20A;  Moderna 12/3/21 Lot# 029H21B; Moderna 9/28/22 Lot# AS7146B
I received my vaccine Saturday the 24th. High Fever 104 degrees starting at 1:30am on April 25th lasting until 9:35 am. I took tylenol around 9 am so my fever went down to 102 degrees at approximately 9:35am on April 25th. Same day around 3:30pm my temp went back up to 103 degrees. That night was rough again with the fever staying steady at 103. Took tylenol again around 3 am and fell back asleep. At 5:40 am April 26th, (Monday) my temp was down to 102 degrees. Finally went down to 99.8 Monday April 26th in the afternoon. Around 8:10pm it went back up to 100.4 and about 30 minutes later it was back to 101. Held steady through the night around 101 degrees. It's now Tuesday but my temp is back down to 99 degrees. Sunday and Monday I had extreme body aches, sweating fits, unbearable headache, sore arm, shortness of breath, extreme fatigue, loss of appetite. It's now Tuesday April 27th and I still have the headache (not as bad), shortness of breath, and loss of appetite. I no longer have body aches and my arm is slowly feeling better where I had the injection.
Pt C/O dizziness after 10 min of receiving vaccine. he also C/O chest pressure.  Pt was hydrated (water) advised rest and 12 lead EKG was done
First shot 2-26-2021 slight fatigued and slight cold like symptoms, second shot 3-26-2021 felt about same until 24 hrs later then very fatigue, chills,aching joints also very nervous felt like I had the flu. Took two Tylenol and .25 alprazlolam and went to bed, 8:00 pm. Next morning little stiff but felt very good. I am a active healthy happy 78 year old with cardio heart disease
Within 15 minutes post vax pt developed an injection site reaction characterized by 3 - 4 cm area of induration, redness, warmth and pain.  Benadryl 50mg was administered and the pt recovered.
headache; sinus pressure; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukaemia.    The patient's past medical history included Lymphocytosis. Concurrent medical conditions included Iodine allergy, Estrogen receptor assay and Drug allergy (SULFA ANTIBIOTICS). Concomitant products included ANASTROZOLE (ARIMIDEX), COLECALCIFEROL (D3), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), PROBIOTICS NOS and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient experienced PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache). At the time of the report, PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) to have an unknown relationship.    This case was linked to MOD-2021-087097 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  MOD-2021-086818:Case received in same source doc email MOD-2021-086711:Case received in same source doc email  MOD-2021-086996:Case received in same source doc email  MOD-2021-085006:Case received in same source doc email
Breakthrough case admission after three vaccines Moderna 8/5/21 Lot# 041C21A ; Moderna 9/2/21 Lot# 041C21A;  Moderna 3/24/22 Lot# 048L21A
This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 13-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown). Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
large red warm swollen 7 cm at injection site required office visit x 2     12/1/21 and 12/2/21  with  patient  placed on antibiotics
Woke up at 5:30am with very severe chills and aches/pains.  Couldn't get out of bed, or stay warm.  Finally dozed back to sleep at about 9:00am.  Woke 90 min later, with chills (fever?) subsided, and the sheets all sweaty.  Felt a little weak and achy, but otherwise fine!
Received 2nd Moderna 2/10/21.  Later that evening felt feverish.  Next morning 2/11/21 had a syncopal event in her bathroom.  Presented to the ER and was observed overnight and was seen by urology.  Was thought to possibly have had a seizure.  MRI, EEG was unremarkable.  Was not initiated on any meds.
Narrative: Patient presented to ED with suspected anaphylactic reaction due to inactivated polio vaccine; Also was COVID(+) on admission. In the ED, patient received 0.3mg epi, 50mg diphenhydramine, 20mg famotidine, and 125 mg prednisolone via IV. Patient was admitted for further inpatient management.
Information has been received from a registered nurse concerning a 17 month old male with no medical history or allergies who on 02-JUL-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 657787/0718U). There was no concomitant medication. On 04-OCT-2007, the patient developed a mild chickenpox rash. No treatment was needed. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Initially, I started I had fever of 102, for 2 1/2 weeks, I felt very tired and upset stomach, it hurt, I was fatigue, I went to the doctor, and they did blood work for a whole month, and they found reactivation of Epstein Barr (EBB) and hepatitis.  I had fever that lasted for weeks and until the liver enzymes were normal, this was after the fifth week.