chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received COVID vaccine (Janssen) on Saturday, March 6th at the Fairgrounds, patient called Health Department on 5/12/21 with the following report.   Approximately the week of April 6th patient begin experiencing weakness in both thighs. Patient describes the weakness feeling like 'a twisted tendon', reports difficulty standing from a seated position, and reports pain when walking. Patient saw physician, on May 7th who prescribed a muscle relaxer and recommended PT. Advised patient to return if symptoms persist for an ultrasound.
Very strong waves of spasm- like pain from shoulder down to elbow and sometimes fingers that lasted to about 6 am the following morning.  Also could not move left arm without very strong pain in shoulder and arm.
A report has been received from a Health Professional concerning a 70 year old, subject of unknown gender, who had been receiving Nasal FLUMIST (INTRANASAL). 70 years patient was inadvertently administered by FLUMIST, which started on 10-Oct-2014. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST TO A 70 Y/O PATIENT is unknown. The report was considered to be non-serious.
Rash, ErythemaMultiform, UrticariaPruritus,  redness, warmth at injection site  Narrative:
Patient presents to hospital ED one day after receiving dose #1 of Pfizer COVID-19 vaccine reporting fatgue and found to be hypokalemic and tachycardic (other vital signs within normal ranges). Observed, administered IV fluids and PO potassium, and discharged to home stable. Possible etiologies include recent death in family or adjustment in anti-hypertensive medications but event was soon after vaccination.
pt recvd vax & became cyanotic around lips; HR & resp dec; P60 & R16 did not lose consciousness- laid on floor elevated legs; 911 called by nurse; pt given 02;
Patient c/o redness at injection site. Applied Benadryl cream and symptoms improved. Patient called pharmacy on 2/24/14 to report adverse reaction. Pharmacy asked her to follow up with primary care provider.
Approximately 12/13 hours post-vaccine dose #2 I was woken from my sleep with severe body aches. Extremely uncomfortable, from neck to back to calves, without improvement with Tylenol or ibuprofen, causing me to be unable to sleep. Around hour 20 post-vaccine, I started to get chills. It wasn?t just feeling cold or shivering, it was full body convulsions that lasted approximately 15 minutes.  I became nauseas and dizzy after that for about an hour, unable to stand or walk anywhere. The severe body aches continued, with no improvement from Tylenol or ibuprofen or heating pad. Aches resolved around hour 30 post-vaccine and the only symptom left was pain at the injection site.
This serious spontaneous case, initially received on 01-Jun-2017, was reported by other health professional (registered nurse) and concerns students in an academic campus, who all received flu vaccine. This case deals with eleventh of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns 18-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 20-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017  FLUCELVAX commercial season. Therefore no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not provide seriousness assessment. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number 1022277) received from quality assurance department on 29-Jul-2017: QA investigation results were updated. Narrative amended accordingly. Non-significant case correction received on 10-Aug-2017: Narrative and case comment were corrected.
arm pain; This is a spontaneous report from a contactable consumer (patient, self-reporting). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number and expiration dates were not reported), via an unspecified route of administration on an unspecified date in Jan2021 as a single dose for covid-19 immunization. Medical history included autoimmune disorder (He says this issue is separate from the vaccine, a possible autoimmune disorder with symptoms that developed well before the vaccine). The patient's concomitant medications were not reported. The patient received the first dose of the vaccine a week ago today. He stated he has no concerns about side effects. He had some minor arm pain but that was not his concern. He was not taking any medications. However, he has been advised by a physician to take a high dose of prednisone, 15 mg for 3 days, to see if it resolves another issue he had. He says this issue is separate from the vaccine, a possible autoimmune disorder with symptoms that developed well before the vaccine. The caller asked if this would interfere with the efficacy of the vaccine. The caller asked would an antibody test reveal how much protection patient have. Outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pt had an adverse reaction on 8/4/21 shortly after receiving 1st dose Moderna (swollen & sore arm). Pt came into clinic for 2nd dose (date of first dose was overlooked), and 2nd dose administered today, on opposite arm. Spoke w/ pt, she stated that the MA who administered the first dose advised she can come back to clinic anytime after 8/24. Pt also stated her arm is just sore.
Redness appx 8x11 cm, warm Erythema mild. Onset 2d after injection. Cool compresses w/ relief.
This spontaneous report was received from a nurse and concerns an 11-year-old male patient. The patient had no pertinent medical history and not known drug reactions or allergies. The patient's concomitant medications were not reported. On 02-AUG-2018, the patient was vaccinated with the first dose of GARDASIL 9, 0.5 ml, intramuscularly in the left deltoid (lot# N035032 and expiration date: 24-SEP-2020) for human papilloma virus prevention and with MENACTRA intramuscularly in the left deltoid (lot# U5916AA with expiration date: 27-JUN-2019) (dose not reported) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, intramuscularly in the right deltoid (lot# U5850AA with expiration date: 17-JAN-2020) (dose not reported). On 03-AUG-2018, the patient broke out of hives on his torso, abdomen, back and groin, both arms and larger hive on his right arm. The patient's parent spoke with on call nurse. No laboratory diagnostics or studies were performed. The patient received an unspecified treatment. On 05-AUG-2018, the hives subsided. The relatedness between the event and GARDASIL 9, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and MENACTRA was not reported.
Patient was given PEDIARIX (LT), HIB (LT), PREVNAR (RT) & ROTATEQ vaccines on 6/17/08 and went to the ER that evening for seizure (strange twitching). She was admitted to the hosp with fever 103.3, sterile abscess to (L) leg and febrile seizure.7/7/08-ER records received for DOS 6/18/08-DX:Immunization reaction. Subjective fever, crying and jerking this morning. Small sterile abcess right upper thigh.
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Apr-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   No treatment information was provided.  The number was reported.
developed acute pancreatitis; abdominal pain; This is a spontaneous report from a contactable physician (patient's grandfather) via medical information team. A 13-year-old male patient received BNT162B2 (COMIRNATY; Lot number and expiration date: Unknown), via an unspecified route of administration in May2021 (at the age of 13-years-old) as dose 2, single for COVID-19 immunization but not in a military facility. The patient had no relevant medical history/patient's history. The patient was very healthy with no previous illness. There were no concomitant medications/other products reported. The patient was not on any medication and had no exposure with a viral illness. Historical vaccine included BNT162B2 (COMIRNATY; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations within 4 weeks of COVID vaccine. A few days ago in Sep2021, he developed abdominal pain which they thought could have been a kidney stone, but after bloodwork, it was determined that he developed acute pancreatitis. His levels warranted him to be hospitalized and admitted in hospital on 16Sep2021 for these events and was ongoing. He's not currently on any medications but did receive the vaccine approximately three months ago. The patient had an emergency room visit for these events but not to physician's office. No investigation assessment and no relevant tests were reported. The reporter wanted to see if there have been any case reports of patients developing pancreatitis specifically after receiving the vaccine and he doesn't necessarily believe it was caused by the vaccine, but the doctors at hospital asked him that if he had received the vaccine which was three months ago but it could possibly be a delayed reaction. The outcome of acute pancreatitis was not recovered and abdominal pain was unknown at the time of report.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Pancreatitis acute, Abdominal pain cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.
Rash below inj. site that spread to her chest and neck. Complained of fatigue and difficulty walking day after shot. Doing better after taking antihistamine. Told to call MD.
Patient received Moderna Vaccine from Health Clinic at local spot on 03/05/2021.  Patient had low grade fever, for a couple of days after vaccine and has improved.  Patient noticed a small amount of redness at vaccine site on 03/07/2021 when bandaid was removed.  Patient stated that she had increased redness, swelling, pain and heat to left upper arm vaccine site and was seen to be sure it wasn't cellulitis.  Patient informed that this can be an adverse reaction of the vaccine.  Patient denies any further fever, fatigue or other signs or symptoms of infection.  Erythema, edema, and heat to 3.5 x 4 " to left upper arm.  Patient informed that a report would be made and to apply warm moist compresses to site and to take Tylenol and/or Ibuprofen for pain.  Patient notified to call clinic if symptoms worsen or a fever occurs.
Information has been received from a physician and other health professional concerning a 17 month old (previously reported at 18) female patient with no previous medical history and illness at time of vaccination, who on 10-JUN-2008 was vaccinated with a dose of VARIVAX (lot# 660496/0389X) SQ in the right thigh. On 14-SEP-2008 the patient was diagnosed with shingles, erythematous rash with some clear vesicles in dermatomal pattern on back extended under axilla. On 25-SEP-08, the patient recovered without any signs. No further information is available.
Severe constipation within 3 days of 1st vaccine but resolved and I didn't think more about it. Then after the 2nd Covid  vaccine on April 21, I had severe constipation that has not resolved.
This case was reported by a other health professional via call center representative and described the occurrence of heaviness in limbs in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced heaviness in limbs. On an unknown date, the outcome of the heaviness in limbs was unknown. It was unknown if the reporter considered the heaviness in limbs to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who is an Office Manager. The healthcare professional reported that, her arm felt heavy after receiving the SHINGRIX. No further information was collected at the time of the call. This case has been linked with US2018114223, reported by the same reporter.
Client arrived at clinic location for dose 2 Moderna vaccine. Moderna vaccine not in approved age range to be administered. Client verbalized not having any adverse reaction from first dose other than soreness in the arm. Consulted Dr, approved client to receive dose 2 & be observed x 30 minutes. Client advised to report adverse reactions. Verbalized understanding.
This is a 83 year old male who died on August 21, 2003 while enrolled in RSV S and I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/21/02. The subject died 304 days post immunization while in hospice care. The event was reported by the investigator as not related to the study vaccine. A 15-day follow up report received 10/31/2003 adds: The subject died 305 (corrected) days post immunization while in hospice care. Additional info received 10/24/2003: Date of death is 08/22/2003, changed from 08/21/2003. Diagnosis: Pt died at hospice on 08/22/2003 from CHF and ESRD.
Left inguinal lymphadenopathy 8/25/22 Localized red swelling and induration at site of injection on left thigh with itching
Shoulder pain; Chills; Muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shoulder pain, chills and muscle pain. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
On 12/06/2001 Felt disoriented immediately after vaccine (1000). Felt nauseated (1100). Felt sleepy (1230) took a 2 hour nap. Slight fever ( 1400)- advised to take ibuprofen.
REDNESS AROUND THE INJECTION SITE THEN PROGRESS TO FULL BLOWN REDNESS THROUGH OUT THE BODY.
Headache, Myalgia, Rash, UrticariaPruritus, rash developed 10 days after administration of the second Moderna vaccine. The mild systemic symptoms were present for 2 days post vaccination HISTORY: Employee does not have a history of allergic reactions to shots/meds/food environmental allergies etc...No new foods/lotions etc... No dry skin or skin issues. No voice change or breathing issues. Rare chest tightness when she gets anxious is unchanged . Unchanged dizziness if she stands quickly( BP runs low in general). She had been on 40 mg of celexa for many years and takes no other medications She has had a cat for years without issues Patient had her second Moderna shot 1/27 with 2 days of fever/chills/HA/myalgias/fatigue and right shoulder aching. On 2/7 she developed a mild upper chest and back maculopapular rash with prominent itching. She has scalp itching without an obvious rash. Benedryl 25 mg bid helped partially with the itching but not with the rash All: NKDA until this maculopapular rash PMH: Prior T and A as an adult, chronic anxiety improved with celexa, left wrist surgery for Dequervains tenosynovitis SH: LPN Medications: Celexa 40 mg /day ( trialed weaning in the past which was not tolerated) PHYSICAL: Alert female in NAD Excellent historian normal voice quality Normal gait Hand strength normal and fluid. Well healed left wrist scar Resp rate 12 and even good color CV 60's RRR normal pulse pressure no JVD or edema Skin not dry light maculopapular rash upper chest and upper back extending to the neck No fullness or rash right deltoid not tender to palpation Abdomen and mid to low back distal thighs distally and arms are without rash. FINDINGS: Light maculopapular rash partially treated with low dose benedryl. Possible reaction in a delayed fashion to the Moderna Vaccine verses reaction to celexa, food, or environmental factors DIAGNOSTIC IMPRESSIONS: Mild allergic maculapapular rash partially treated with low dose benedryl. Possible reaction in a delayed fashion to the Moderna Vaccine verses reaction to celexa, food, or environmental factors. INSTRUCTIONS FOR RETURN TO WORK: Off work today for home claritin and benedryl. rtw tomorrow () Return to full duty () Light duty (See EMPLOYEE HEALTH LIGHT DUTY FORM (X) Off duty 2/9 only as of 11AM rtw full duty 2/10 FOLLOW UP RECOMMENDATIONS: Claritin 10mg q AM until rash/itching resolved. Benedryl 25 mg at 3 PM after work and 12.5 mg before bed ( no driving) until rash resolved Prednisone prescribed 20mg up to 2 times/day with food if rash resoled Prednisone prescribed 20mg up to 2 time/day with food if rash progresses and call employee health and PCP and/ or urgent care. I will see her in follow up 2/10 10:30 AM
It was reported that post vaccine pt experienced 6 episodes of tremors, each lasting under one min and shaking uncontrollably. It was reported from physician "I did not associate the complaint of shaking episodes with the vaccine.
10 minutes after immunization patient's husband reported his wife feels pressure at the back of the mouth, tightness. She refused EiPen. I gav her diphenhydramine 25 mg capsule. Called 911. They took her to ER.
I got a mild case of Bell's Palsy. My face did not droop but I could not lift the left side of my face at all. I could not fully smile or flare my nostrils. I also had an earache but no ear infection. I am 10 days into having Bell's Palsy and I have seen an improvement in the movement of my face after one week of Prednisone. But there is still a long way to go before I fully recover.
patient said his arm was sore the day after the dose.  I saw him later and he said it was a little better.  Yesterday I saw him and he said it was hurting all down his arm like a nerve and hadn't gotten any better and was still bothering him
Client reports waking up this morning with "eyes feeling funny...like when you have a fever." Also, "my stomach hurts like when you're really hungry." Denies headache, muscle aches, and unable to state if fever is present. States, "I know something is wrong." Client also reported having flu and td shots from primary physician earlier that day.
BIT ANXIOUS; FEVER OF 110; This spontaneous report received from a patient via a company representative 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced bit anxious, and fever of 110. Laboratory data (dates unspecified) included: Body temperature (not provided) 110. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 110 and bit anxious was not reported. This report was non-serious.
Very swollen, sore neck, shoulder, excessive fatigue, felt ill and very very weak.
No signs or symptoms reported. No other AE or PQC reported.; Improperly stored administered vaccine (7.52 F); This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 09-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # T027304 was confirmed to be valid, for prophylaxis (dose, route and site of administration were not reported). The administered dose was exposed to the temperature of 7.52 degrees Fahrenheit for 6 hours and 4 minutes. There was nor previous temperature excursion. No additional adverse event was reported.; Sender's Comments:  US-009507513-2108USA006759:
Raised rash about 2 in diameter; Red; Itchy; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6205, Expiration date: unknown), administered in Right arm on 12Mar2021 at 12:45 PM (at the age 35-years-old) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history included Hypothyroidism and HTN. Patient had allergies to Sulfa based medications, mollusks. The patient's concomitant medications included Synthroid. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient experienced red, itchy, raised rash about 2 in diameter lasting 2.5 weeks on 12Mar2021.  Patient did not receive any treatment. Outcome of the events was recovered on 31Mar2021.  No follow-up attempts are possible. No further information is expected.