chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received only one dose a year ago; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (The  patient who received only one dose of Twinrix a year ago.).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-SEP-2022 Reporter's Comments: The reporter stated that a patient who received only one dose of Twinrix a year prior to the reporting. The reporter did not consent to follow-up. Additional Supportive Information: The did not received 2nd dose which lead to incomplete course of vaccination.
Patient received a flu and pneumonia vaccine in September. A few days later he complained of a sore arm. He went to the hospital where it was discovered that he had a MRSA infection at the injection site of his flu shot (left arm). The patient was treated with IV antibiotics and released.
She got her vaccine, at 6:00 PM her RA started acting up in both hips, severe pain.  Then the left side of her hip subsided the next day.  She started taking Ibuprofen 800 mg, but the left hip has continued to be very very painful.  Her RA was fine prior to the vaccine.  She has left a message for her doctor to call her in this regard.  She also left a message with no call back yet from her rheumatologist that handles her RA.  She has not had an RA problem for about 3 years until she took this vaccine.   She has gotten her flu shot every year and all of her COVID vaccines, and had no problems until now.
I had body aches after the vaccine which lasted about 12 hours. I began to feel bad like a bad cold on June 19. I tested for COVID-19 on June 20 and it was positive.  I contacted my primary care doctor and she prescribed Paxolovid.  Prior to contacted my doctor, I took something for allergies.
Patient was given Pfizer 12+, but patient was due for Pfizer 5-11.
Fever (100.4 F), chills, felt very run down/tired. Took Advil. Symptoms resolved after 2 days.
Pvcs/palpitaty,  several thousand a day for 4 weeks, then slowly improving after that point.
Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a female patient of unknown age who received a partial dose of vaccine TYPHIM VI (batch number: N1K811M, expiry date: 19-Oct-2019) (dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to vaccine under dose as part of the pre-filled syringe dose leaked out and down the patient's arm and she did not get a full dose. 0.5 mL was attempted to be given. It was also a case of Needle issue as the needle leaked between the hub and the attachment site of the pre-filled syringe. It was also reported She said that she had tightened it on the syringe appropriately. No damage noted to the needle or syringe. It was not reported if any adverse reaction was reported or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information was received on 14-Jan-2019 from a pharmacist. Suspect lot number updated. List of documents held by sender- none.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 single dose vials (lot# K021030, expiration date 22-JUN-2016, dose, frequency and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
fainted with injectionat 330 pm, in night fever shakes, chills later fever. today HA , fever 102.5 emesis post motrin "mouth feels funny"
received 2nd dose 15 days early; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 15-year-old female patient who received HAV (Havrix 720) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 720 (1st dose of Havrix received on 20 Apr 2022.).   On 5th October 2022, the patient received the 2nd dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 5th October 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-Oct-2022 Reporter's comment: The nurse practioner stated that the patient received second dose of Havrix 15 days early and it was due on the 20th October 2022.  The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Havrix, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Approximately 20 minutes after receiving the injection, patient began to feel dizzy and heart was tachycardic in 130s. Patient was put on telemetry. While sitting, heart rate became irregular and variable jumping down to the 60s and seconds later, after a short pause, jumping up to 130s. Blood pressure was elevated at 140s/100. Patient began to have uncontrollable tremors/shakes. Patient was taken to ER at aprox 0500 after the symptoms were resistant to improvement after lying down. 1000cc of normal saline was started and cardiac monitoring was resumed. Patient continued to be dizzy, tremulous and tachycardic. Aprox 0600 patient's symptoms improved and heart rate returned to the 70s and patient discharged home. While at home symptoms returned with variable tachycardia, tremors, dizziness and diarrhea for aprox 2-3 more hours. ZYRTEC was taken aprox 0800. Patient felt more improved around 1300.
Later at night throwing up, quite dizzy, had diarrhea. Was dehydrated and had no appetite. Felt so bad that went to ER twice, on 1/23 and 2/28, but should have gone 3 times. On ER got IV and anti-nausea meds. Followed up with doct after ER visits and got pill for vomiting/dizziness but made it worse. Today still vomiting; diarrhea subsided 2 weeks ago. Allergist recommended flu vaccine.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Information has been received from a 67 year old female consumer concerning herself. The patient's concurrent condition included gastrooesophageal reflux disease (GERD), osteoporosis and liver enzymes and cholesterol elevated (all other lab tests were OK) but did not require medication. The patient's medical history included flu shot. The patient concomitant therapies included PRILOSEC OTC and "ROLAIDS" or TUMS. On 20-JAN-2017 about 14:00 EST, the patient was vaccinated with ZOSTAVAX, 19400 units (one time) (lot#, expiration date and route were not reported) in the right arm and was vaccinated with PNEUMOVAX 23 (strength was reported as 1/25microgram/0 injection, dose was reported as 1/25microgram/0 injection, one time) (lot#, expiration date and route were not reported) in the left arm for prevention. On 21-JAN-2017 about 03:00, she woke up and felt nausea. On the same day, she also experienced soreness/pain at the base of her neck, across her shoulder area which went left to right, and it hurt when she turned her head, though she could turn her head. The pain and soreness was worsening. She also experienced swelling and soreness at the site of her PNEUMOVAX 23 injection. She was experiencing constant pain and had not done anything to treat the pain but was considering taking ALEVE PM or TYLENOL PM. She also reported soreness when she walked and felt like the pain was muscle or joint pain. There was no relevant laboratory data. On 21-JAN-2017, the patient was continued to experience worsening soreness/pain at the base of her neck, soreness/pain across her shoulder area, it hurt when she turned her head, swelling and soreness at the site of her PNEUMOVAX 23 injection and soreness when she walked however the nausea had resolved. Causality between the events, ZOSTAVAX and PNEUMOVAX 23 was unknown. Additional information is not expected as there was no consent for follow up.
Patient received Covid- 19 vaccine on 1/15/2021 at 5.15pm. On the 1/16/2021 around 8.35pm, he had chills and required assistance for walking and up on nurse assessment his temperature noted to be 101.9 F. nurse administered Tylenol 650mg and fluids were given. Up on follow up  assessment of nurse on 1/17/2021 at 1.03am, the repeat  temperature was 103.6F per ear probe. Due  to high fever the 911 was called and was taken to ER.  Normal assessment per ER evaluation and discharged to center with the diagnosis of vaccine reaction without any labs or chest x ray. Up on return to center, his temperature was 101F around 3.45 am on 1/17/2021, he was placed on increased  oral fluids and Tylenol given as needed basis for fever. No more spiking of fever noted after that.  He was hospitalized for Covid - 19 pneumonia from 11/6/2020 to 11/20/2020 at center, during the hospitalization he had intermittent spiking of temperature [101f-102F]. He had prolonged hospitalization due to intermittent fevers only and did not require ICU care. His work up was negative for infection other than Covid -19 infection and received broad spectrum antibiotics.  He lives in facility for developmentally delayed individuals, due to group home setting &  high risk of mortality in developmentally delayed [DD] population with Covid -19 infection - it was decided  to vaccinate with Covid -19 vaccine after 2 weeks of Covoid -19 infection with they remain asymptomatic after 14 days of isolation with contact & droplet precautions.
This case was reported by a healthcare professional and described the occurrence of dizziness in a 12-year-old male subject who was vaccinated with HAVRIX, GlaxoSmithKline.  Concurrent vaccination included VARIVAX (Merck) given on 6 August 2007.  Concurrent medications included Fexofenadine hydrochloride (Allegra).  On 6 August 2007 the subject received 1st dose of HAVRIX at 0.5 ml in the right arm.  A short time after vaccination with HAVRIX, as the subject was on his way to the car, he experienced dizziness, sweating, pallor, almost fainting and legs buckling.  He returned inside the office and was watched and allowed to recline for two hours.  He never lost consciousness.  His blood pressure and glucose were normal.  He also reported tingling hands most likely from hyperventilating.  He was released after two hours.  All events were resolved, with the outcomes of tingling hands and hyperventilation not specified.  The events of dizziness, sweating and pallor were reported as possibly related to treatment with HAVRIX.  Almost fainting and legs buckling was unrelated.  Relationship of tingling hands and hyperventilation was not reported.  Follow-up received on 20 September 2007 from the healthcare professional indicated that the events resolved.
11/15/14: Pt. called this am to report "big red blobs" on upper arm near shot injection site. C/O only mild soreness. Arm feels a little warm to the touch. No itchiness. Pt feels fine-able to move arm normally. Denies fever. Band aide removed this am by pt
Severe lower back pain, seems like muscle spasms.  Cannot rise from sitting position without severe back pain.  Standing, sitting, lying down is pain free unless I try to change position.
Patient reports bruising on hip, ankle, forehand, foot, spasms in neck/hand and pain in right hip down to the foot. Went to massage therapist 5/11/21. Was seen in the office 6/16/21 and no evidence of synovitis on exam. No appreciable bruising. denies bleeding gums. Patient reported a previous diagnosis of "boutique lupus"but labs are normal. patient continues to report hip and hand pain and hand spasm. pt now reporting palpitations - seeing cardiology
pt recvd vax; 3 hrs after vax, started rash; face swollen; ear red; rash devel over all body; seen at hosp; given med;
The patient has a history of lung cancer and COPD. He was brought to the ED via EMS on 4/25 with sore throat, shortness of breath, decreased appetite and hemoptysis. Additionally, the patient tested positive for COVID two days prior. Ultimately, he was admitted 4/25 - 5/1. Discharge diagnoses include acute hypoxic respiratory failure secondary to hemoptysis and streptococcus pneumonia, among other diagnoses. The patient was admitted to the ICU and intubated for work of breathing as well as to prevent further bleeding with coughing. He was extubated on 4/27. Per the discharge summary, the provider notes "He was noted to be COVID positive, but unclear this was actively contributing to his respiratory failure, but certainly possible." Of note, the patient has received the primary COVID vaccine series and three boosters.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on the patients' concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX, lot # M009766, expiration date: 23-FEB-2018 (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 19.6 degrees Fahrenheit for 5 hours and 15 minutes. The temperature excursion was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. Additional information has been requested.
rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape; injection site became warm, red, and caky/warm to touch; injection site became warm, red, and caky; injection site became warm, red, and caky; bad firey red sore throat/very odd sore throat; bad firey red sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat), PHARYNGEAL ERYTHEMA (bad firey red sore throat), VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky) and VACCINATION SITE SWELLING (injection site became warm, red, and caky) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Bactrim.). Concomitant products included MONTELUKAST for Allergy, ROSUVASTATIN for Cholesterol, VITAMIN D NOS for Osteoporosis.    On 25-Feb-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat) and PHARYNGEAL ERYTHEMA (bad firey red sore throat). On 08-Mar-2021, the patient experienced VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky) and VACCINATION SITE SWELLING (injection site became warm, red, and caky). On an unknown date, the patient experienced VACCINATION SITE RASH (rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape). On 07-Mar-2021, OROPHARYNGEAL PAIN (bad firey red sore throat/very odd sore throat) and PHARYNGEAL ERYTHEMA (bad firey red sore throat) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site became warm, red, and caky), VACCINATION SITE ERYTHEMA (injection site became warm, red, and caky), VACCINATION SITE SWELLING (injection site became warm, red, and caky) and VACCINATION SITE RASH (rash appeared at the injection site, rash was oblong (5" long and 3" wide) in shape) had resolved.            Treatment details included antibiotics was prescribed but didn't took those medications. Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI On 23-Jun-2021: Added patient demographics, added medical history, added concomitant medication
Numbness, tingling & pain both hands, specifically index, middle & ring fingers, decreased strength and burning sensation, slight edema.
5 people she knew were vaccinated and died; This is a spontaneous report received from Pfizer sponsored program from a non-contactable consumer. This consumer reported same event for 5 patients. This is the 5th of 5 reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated during conversation that 5 people she knew were vaccinated and died. She did not have any other information. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101451919 same reporter/drug/event, different PTs; Reported Cause(s) of Death: 5 people she knew were vaccinated and died
Approximately 2 hours after recieving vaccine patient reported itching of his right arm which he scratched vigorously.  He then developed redness and swelling below the injection site.  Ice packs applied to area.
I experienced extreme fatigue, shortness of breath, sluggishness and had to stay in bed for a couple days.
Was acting completely normal all day (1/22), then we put him in the bath that evening. Around 7pm, he stopped talking to me, wouldn't answer questions, and was shaking all over. The water was very warm, not cold. We got him out of the bath and in a towel. He shook the whole time we were getting him dressed. Was very emotional. We got him in pajamas and wrapped in a blanket. He finally stopped shaking but was lethargic and not talking much. He woke up the next morning (1/23) with a fever of 100.5. He has been lethargic all morning.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M033214, expiration date: 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained.; Sender's Comments:  US-009507513-1611USA004113:
I was vaccinated in January 2021and I received both Pfizer shots. But a month later I started getting these little painful raised sore spots on my scalp. After about a month they opened up and turned into rings after two months it had left a hole. Also had very sharp stabbing pains in abdomen and skin wet very numb and tingly. Got vaccinated again in June 2021, The same thing happened again of course on the scalp, raised sore spots that repeated what I explained above. They both took three months or more to heal yeah leaving holes where they were. Got the booster shot and the same thing happened again only a little more intense. As I sit here writing an hour I have lesions on my scalp that are painful and have opened up and will turn into holes. Eventually I'm thinking they will scar over completely. I believe it's the vaccine that has done this. As explained above the sharp pains in my abdomen. I've never experienced any of these issues before until I got the vaccines. Also I am starting to get tingly fingers like I'm losing feeling in my hands and I get a deep sharp ache in my forearms. I don't know if this is linked to the shots, but it did start after the second time I was vaccinated and after the booster shot. As for the scalp lesions they happened from the first vaccine doses, the second vaccine doses and the booster shot. I don't know if my immune system got over reactive or overactive. Pardon my non-medical term use of words lol I'm not school with medical terms. I am quite worried that this is going to happen to leave holes in my scalp. I hope this helps. I was wondering if this is happened to anybody else? I was wondering if anyone else had issues with scalp lesions?
Dry mouth, pain lower back, dehydration, alert reaction, rash, skin itching, treatment at hospital.  MR received from the VA documenting 5 office visits between 01/2005 and 10/2006. HPIs:Ankle sprain 06/2005. C/o LBP in OV of 10/2005. Txd with Naproxen. Left shoulder tendonitis and ankle sprain 2' to a fall 03/2006. Txd with ibuprofen and steroids. C/o LBP in OV 10/2006.  Txd with PT. Assessment: LBP 2' to Lumbar Myositis and Spasms. No nerological deficits or radicular signs on PE.