chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse outcomes or side effect were reported or observed by the patients who received the administered doses by an experienced HCP; HCP (nurse) called to report VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023 but she was not made aware until today (06/26/2023).  The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 12-JUN-2023 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W031813 and expiration date 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration was not provided) (product storage error and no adverse event). The product was stored at 10.8 degrees Fahrenheit (F) for 8 hours, 23 minutes and 0 seconds with a supported temperature excursion stability evaluation.
Patient given FLUMIST on 1-10-13 after already given it on 10-4-12. No adverse reactions noted.
Presented to ED on 12/2/21 with a 2 day history of increasing weakness, shortness of breath, and cough.  Patient tested +ive for COVID 19 in the ED.  CXR failed to show evidence of pneumonia.  She is currently on 4L NC with stable O2 saturations but had dropped to 88% on RA.  She is noted to have an AKI with a serum creatinine at 1.6mg/dL up from a baseline of 0.7mg/dL.  She does report poor oral intake due to not feeling well for the past couple of days and has continued to take lisinopril and lasix daily.  She remains hemodynamically stable.  She will be admitted for further evaluation and management at this time on 12/2/21. Started on dexamethasone, remdesivir, ceftriaxone and azithromycin. The patient was accepted to a swing bed. She will continue on supplemental oxygen as needed - currently on 2L/min. Discharged on 12/9/21
A non-serious spontaneous report of administration of expired vaccine was received from a registered nurse/health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 27-Jan-2010, the patient received expired H1N1, Intranasal, for an unknown indication. The product expired on 26-Jan-2010. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 03-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date; 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hypereosinophilia with fever and enteritis. Anorexia presented within 24-48 hours of injection, first episode of diarrhea 48-72 hours, becoming severe and requiring rehydration and potassium replacement at walk-in clinic on 1/26/21. Labs drawn at visit showed hypereosinophilia (14%, 1700). Patient started 3 day course of 30 mg prednisone daily; Lab redraw on 1/29 showed eosinophils at 16%, 2600, fever (intermittent to 102 F) and diarrhea continuing. No other household members sick. After telemedicine appoitment with Allergist, patient started on methylprednisolone dose pack, diarrhea and fever resolving.
I got my 2nd vaccine on February 27th, and about a week later I noticed that the muscles in my calf were twitching, which has never happened to me. I went to my primary care and he referred me to a neurologists. She said it was benign calf fasciculations. She prescribed Coq10, B complex, and magnesium. That seemed to help with the feeling of the spasms, but the spasms still continued. And that has continued to this day, and was almost constant. After the 4th dose, the 3 days after I was feeling normal in the morning, but by night the spasms were very pronounced and uncomfortable. The next morning it got worse and I started to feel a pins and needles sensation which then turned into a burning sensation on both my lower legs, from my knees to my feet. Saturday night I went to the ER because my legs were burning and I started to have uncontrollable shivering. At the ER they ran the standard bloodwork, which all came back normal, and they gave me a muscle relaxer and told me to follow up with my neurologist, and I do have a follow up appointment with her soon.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 51-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 20th July 2020). On 26 April 2018, the patient received the 1st dose of SHINGRIX. On 27th April 2018, 1 days after receiving SHINGRIX, the patient experienced headache, lip blister, rash, fever and pruritus. The patient was treated with ZYRTEC and triamcinolone. On an unknown date, the outcome of the headache, lip blister, rash, fever and pruritus were unknown. It was unknown if the reporter considered the headache, lip blister, rash, fever and pruritus to be related to SHINGRIX. Additional information was received as follows: On 26th April 2018 at 15:00, the patient received SHINGRIX on left deltoid. The patient experienced the rash all over her waist, arms, legs and thighs. The pharmacist had not follow-up with the patient since, so was not sure if the symptoms had resolve.
Hospitalized 11/26/2021-still currently hospitalized; COVID-19 positive 11/26/2021; fully vaccinated plus booster  ASSESSMENT Principal Problem:   AKI (acute kidney injury) (HCC) Active Problems:   Uncontrolled type 2 diabetes mellitus with hyperglycemia (HCC)   Chronic atrial fibrillation      PLAN   Covid-19 Pneumonia Vaccinated, received booster (11/9) Symptom onset about 2.5 weeks ago with body aches, fatigue, fever, cough, balance difficulties CXR with multifocal opacities non specific but compatible with Covid pneumonia Oxygen saturation normal on room air Not candidate for MAB Continue to monitor, check CRP, D-dimer, daily labs 12/4/2021 notes: Nausea/Vomiting/Diarrhea.  Due to colonic ileus, distal SBO CT abdomen and pelvis on admit: showed colonic ileus but no bowel obstruction AXR report reviewed from 11/27  findings consistent with ileus.  Possible partial obstruction. Repeat CT abd/pelvis on 11/30 with distal SBO.  Gastric Grafton completed on 12/02/2021 without evidence of obstruction.  Patient advance diet to solids and had return of nausea and emesis.  His appetite returned today Covid-19 Pneumonia.  Improving from a respiratory standpoint as symptoms started 2.5 weeks prior to admit Vaccinated, received booster (11/9) Symptom onset about 2.5 weeks ago with body aches, fatigue, fever, cough, balance difficulties Finished COVID isolation CXR with multifocal opacities non specific but compatible with Covid pneumonia Oxygen saturation normal on room air Not candidate for MAB, Decadron or remdesivir due to timing of symptoms and lack of hypoxia Dispo: Patient unable to tolerate full diet, will limit to liquids today. Appreciate GI and DGMS inputs 12/7/2021 note:  ASSESSMENT / PLAN: Nausea vomiting resolved Partial small-bowel obstruction, colonic ileus resolved Patient currently tolerating soft diet Patient is stooling, no nausea or vomiting. Plan - Continue slow advancement of diet as tolerated COVID-19 pneumonia Fully vaccinated Asymptomatic, did not require treatment Off of severe respiratory isolation   PT/OT recommends SAR   Plan for Home patient considering sore hopeful complete resolution of SBO likely in 1-2 days Can likely DC on oral antibiotics to complete 7 days of treatment for anal abscess
Patient  and wife called 4 days later 06/16/23 that later that afternoon patient was itching with no rash or redness, spoke with provider who told patient to take benadryll and to call the office if no relief.
The Pfizer vaccine that was given to this patient had expired on 9/30/2022. Notified the patient's mother right away and scheduled him to come back in to repeat the second dose. Notified my supervisor right away of what had happened.
Rash that itches on the front of my neck and on the inside of my elbow. Comes and goes. But has basically been a consistent problem since the vaccine.
On Tuesday (9/27/11), patient noticed the pain on the left arm and then on Thursday (9/29/11) she felt the dime sized lump on the left armpit area.  Right now (10/02/11) Saturday at 12:40pm, it's too sore to touch.  No treatment yet, just concerned whether the issue is vaccine related.
Hot temperature on the face; Lower lip became puffy; Right side of face became puffy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Hot temperature on the face), LIP SWELLING (Lower lip became puffy) and SWELLING FACE (Right side of face became puffy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 431M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy and Drug allergy (Diflucan). Concomitant products included PROBIOTIC 10, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Hot temperature on the face), LIP SWELLING (Lower lip became puffy) and SWELLING FACE (Right side of face became puffy). At the time of the report, PYREXIA (Hot temperature on the face) outcome was unknown and LIP SWELLING (Lower lip became puffy) and SWELLING FACE (Right side of face became puffy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment related information has been reported.   Reporter did not allow further contact
DVT; blood in urine; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A patient of unspecified age and gender received the second dose of bnt162b2 (BNT162B2, Solution for injection lot number and expiry date were not reported), via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection lot number and expiry date were not reported), on 03Feb2021 for COVID-19 immunization. On 24Mar2021, the patient had blood in urine. After visiting ER (emergency room) 2 times, the patient got DVT (Deep Vein Thrombosis). The doctors were also not sure if that's because of the shot or not. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
0820 received vaccine 0830 reported feeling hot, tingly, sweaty 0835 elevated BP, elevated HR - placed in supine position, offered oral fluid 0840 continued elevated BP, elevated HR - continued to monitor 0915 continued elevated BP, elevated HR - continued to monitor 0930 reported feeling hot, tingly, sweaty with position change from supine to sitting,  BP reduced, HR WNL 0935 transported to ED for continue symptoms > 1 hour post administration
Within 5 hours of receiving the vaccination, I started having a skin reaction. Hives spread throughout my body, itchy bumps that appeared and disappeared.
Shot was given in my left arm. I developed a severe headache on the right side of my head three and one half days after my shot. I then developed a rash in localized spots on the upper portion of my right arm and at the base of my neck in back on the fourth day. The rash looks like many small blisters clustered together. I have pulsing nerve pain in my right shoulder and upper arm. The right side of my forehead feels sensitized, though not painful. The rash neither itches nor hurts at this time. My husband is a physician. He said the rash and symptoms are typical of shingles.
This spontaneous report was received from a nurse referring to a patient of unknown age. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. The patient was vaccinated with GARDASIL first dose on 20-AUG-2012, the second dose on 10-JUL-2013, the third dose on 30-DEC-2013 (lot#, expiration, dose, frequency and route were unspecified) (onset approximated to 2013). On 28-JUL-2016, the patient inadvertently received an additional dose of GARDASIL 9 (Lot# L024993 with an expiry date 17-OCT-2017) (dose, frequency and route were not reported). No adverse effect was reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
This spontaneous report as received from a health care worker refers to 8 patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot #0306AE as reported) anywhere from 29-JUN-2012 till the time of the report instead of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No adverse events reported at time of the report. It was unspecified if the patients had sought medical attention. This is one of two reports from the same source (the other report MARRS # 1207USA010810). Additional information has been requested.
Fever, nausea, blinding migraine  DEBILITATING fatigue, chills with teeth chatter (5 hours), body skin hot to touch, severe pain at shoulder cradle and unable to lift Or use arm, leg tremors, torniquet-tight feeling in lower leg right below knee that turned to numbness then pins nd needles, underlying headache every day since first dose, sleeping 12 hours a night although my usual is between 6-7 hours, no energy, have trouble performing most physical tasks, losing words as I'm speaking, forgetting simple I formation such as my son's fiance's name.  Moat of these are ongoing
No adverse event reported. 3rd dose of Moderna administered accidentally as booster before Moderna boosters were approved for administration.
A non-serious spontaneous report of 19 month old patient was administered FLUMIST, not eating as much and not drinking as much has been received from a health professional concerning a 19-month-old female, subsequent to receiving FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 05-Jan-2011. The patient's mother reported that the child was not eating and drinking as much as she normally did. The outcome of the event of 19 month old patient was administered FLUMIST was considered resolved while the outcome of not eating as much and not drinking as much was unknown.
Within a few hours after receiving the vaccine, right arm started hurting, soon after the body aches and chills set in. Overnight my arm hurt so bad i couldn't roll over onto that side or lift my arm up. I developed a fever around 11 pm and it spiked to 101.4 for a few hours before I started taking motrin. Fever was gone by the morning but I had to take it around the clock for about 48 hours or else the body aches and chills would set back in.
Message received from the daughter of the patient, daughter states that the 3-4 days after the administration of the vaccine that she reported to feel unfocused and "out of it", falling asleep more, and was seen by physician who advised to keep an eye on her, then was later found slightly unresponsive, transported to hospital and found to be suffering from stroke. Patient later discharged from hospital to nursing home and stayed there until 3/28/2021, where she was later transferred to the care of the family and passed away on 4/6/2021. Daughter of patient
This is a spontaneous report received from a non-contactable consumer. A 57-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Extreme fatigue"; PAIN (non-serious), outcome "unknown", described as "every movement hurt". Additional Information: The patient and her husband told their friend that they both had side effects from the second dose of the Pfizer COVID-19 vaccine as. The patient and her husband both experienced extreme fatigue the day after getting the vaccine; and every movement hurt is how they described it. They were both tired for the next few days after that, but not enough to interfere with daily activities. 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-2021300751 Same reporter, product, and event; different patient.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 14-SEP-2015, the patient was inoculated with ZOSTAVAX at a health services facility as recommended for routine adult health maintenance and for the long-term prevention of shingles (dose, route, and lot # not provided).  The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 13-JUL-2016, the patient was treated by a Nurse Practitioner at the same facility for the onset of a severe vesicular rash which was diagnosed as severe herpes zoster. She was prescribed acetaminophen and VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 12-year-old adolescent child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which the vaccines were stored, dropped to 32 F and was out of range for a total of 1 hour and on for 2 weeks. On 01-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018, dose: not reported) that was stored out of recommended temperature. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realised that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
diagnosed with chilblains with NO exposure to cold temperatures; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization.  The following information was reported: CHILLBLAINS (non-serious), outcome "unknown", described as "diagnosed with chilblains".  Additional information: Patient reported as diagnosed with chilblains with NO exposure to cold temperatures. In addition gave several friends who also were in the same situation following their vacation with Pfizer. Some of the research that patient read indicates a connection to Covid or the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness at injection site was first noted. Patient came into the clinic at 4:30 on 1/8/2016 reporting joint tenderness in left shoulder. Has a red/warm area measuring 10.5cm C 13cm. was instructed by provider to take anti-inflammatory medication and to apply ice. Return on Monday 1/11/16 if worsens or no improvement.
Screaming & crying x 9 hours & inconsolable until 8:30 pm.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298674, 2018SA298672, 2018SA298677, 2018SA298679, 2018SA298676, 2018SA298678, 2018SA298675 and 2018SA298676, same reporter. This case involves a 46 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On 25-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA, expiry date 15-May-2019 via intramuscular route in the left deltoid. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that 46 years patient was inadvertently administered FLUZONE HIGH DOSE. The patient did not experience any adverse reaction after the injection. 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. List of documents held by sender- none.