chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature dropped to 93, 93 then 98; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE DECREASED (non-serious) with onset 11Mar2021, outcome "unknown", described as "temperature dropped to 93, 93 then 98". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Medical Information:  There were no unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
TINGLING AND NUMBNESS IN FINGERS, HAND, AND ARM. SOME PAIN INVOLVED AND COULD NOT SLEEP LAST NIGHT
swollen left arm around her injection site area; itchy rash around her injection site area; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen left arm around her injection site area), VACCINATION SITE RASH (itchy rash around her injection site area), HEADACHE (headache) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The medical history was not provided by the reporter.     On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen left arm around her injection site area), VACCINATION SITE RASH (itchy rash around her injection site area), HEADACHE (headache) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Rash, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swollen left arm around her injection site area), VACCINATION SITE RASH (itchy rash around her injection site area), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.
Initial report received from non-healthcare professional on 25 August 2014. A male patient, whose date of birth, age at the time of event, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD, batch number: U5015AA (dose number, route and anatomical site of administration were not reported) having expiry date 25 March 2015 on an unspecified date. It was reported that on an unspecified date, after receiving FLUZONE HD vaccine, the patient experienced an unspecified adverse reaction. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was unknown. Documents held by sender: none.
No adverse effects; the patient was administered improperly stored Gardasil 9; This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 20-AUG-2019 the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R016970, expiry date: 22-MAR-2021, anatomical location and route was not reported) for prophylaxis (product storage error). The vaccine was exposed to an unknown temperature for an unknown time frame. Previous temperature excursion was noted as follows at a temperature of 15.3 C for 5 hours 13 minutes. No digital data logger was recorded. No adverse effects reported.
My are turned red around and under the area where I got my shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (My are turned red around and under the area where I got my shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (My are turned red around and under the area where I got my shot). At the time of the report, VACCINATION SITE ERYTHEMA (My are turned red around and under the area where I got my shot) had not resolved.            Concomitant product information was not provided.  Treatment included an unspecified cream.
This spontaneous report as received from a consumer refers to her friend. The reporter reported that the patient had a terrible experience after being administered ZOSTAVAX. The outcome of had a terrible experience after being administered ZOSTAVAX was unknown. Additional information is not expected.
Ran a fever at night the first 2 days, the second day my arm started getting red, swollen and painful
Pt notes about 7 days after Moderna COVID vaccination to have a large (9cm x 8.5cm), erythematous and swollen welt on her left deltoid (where she received her vaccine. The area is warm to touch and pruritic.
Dose received: 3; Headache; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 22-year-old female patient received bnt162b2 (BNT162B2), administration date an unknown date in 2021, (Lot number: unknown) at the age of 22 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified) for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified) for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received: 3"; HEADACHE (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "headache".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Myalgia, Fever, CoughWheeze, fatigue Narrative:  fever x 2 days; 3-4 days of headache, sore throat, fatigue
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA256264 (Same reporter). This case involves a 4 years old female patient who was vaccinated with 0.5 ml dose of IPOL (Batch number: NIG411M and expiry date: 28-Jul-2018) (dose in series, route and site of administration were not reported) on 28-Aug-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccine had been out of range for over 30 minutes and should of been discarded. Neither have an adverse reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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 the sender: None.
found a leftover saline diluent that was supposed to be mixed in with the HIB with no reported adverse event; Initial information regarding an unsolicited valid non-serious case from a other health care professional via Medical Information (Reference number- 00522974) and transmitted to Sanofi on 17-Mar-2021.  This case involves a patient of unknown age for whom it was reported found a leftover saline diluent that was supposed to be mixed in with the HIB (PRP/T) VACCINE [ACT-HIB] (product preparation error) (lot number: UJ266AA and expiration date: unknown] via an unknown route at an unknown administration site for prophylactic vaccination.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  It was also reported that that it was probably another sterile diluent that they use for their other vaccines. Caller asking if the dose needs to be repeated. Caller asking if the dose can be repeated at any time.  It was an actual medication error due to wrong diluent used (latency: unknown).  At the time of report, no adverse event was reported.  It was not reported if the patient received a corrective treatment.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
On 03/21/2023 I noticed itching in my vaginal area I used a mirror to self-examinate and I noticed that I had an open wound in my vagina. I contacted my Physician and was advised to advised to use topical Vaginal moisturizer for dryness and an Antibiotic to be taken every 72 hours. . I was tested for STD's and Yeast Infections and was negative. I have been referred to an OBGYN but have not been able to get an appointment until June.
Pt had violent reaction 24 hours after vaccine had to go to ER extremely low Blood Pressure, shallow breathing. Pt hospitalized on 7-6-15 with diarrhea for 4 days, increased temp 103.5 degrees goes back up after wares off. On oxygen, IV antibiotics, put in ICU. Seeing infectious disease MD due to infection resistance to (-) gram rod infection.
Information has been received from a registered nurse concerning a 6 year old male who was vaccinated on 10/1/01 with a dose of varicella virus vaccine live (lot number was unavailable). The patient was seen on 12/24/03 with pox on her legs, thighs, and back. No itching was noted. The child was noted to have chicken pox breakthrough. Unspecified medical attention was sought. There was no product quality complaint. The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live and developed chicken pox breakthrough/shingles (WAES0404USA00205, 0404USA00418, 0404USA00419, 0404USA00420, 0404USA00421, 0404USA00422, 0404USA00423, 0404USA00424, 0404USA00425, 0404USA00426, 0404USA00427, 0404USA00428, 0404USA00429, 0404USA00430, 0404USA00431, 0404USA00432, 0404USA00433, 0404USA00434, 0404USA00436). No further information is expected.
30 second grand mal seizure and Hep A. No fever at 9/26/14. Flu mist 9/17/2014 - 9/26/14.
ITCHY EYE(S), NOSE AND OROPHARYNX WITHOUT REDNESS,SWELLING OR DYSPNEA - ADMINISTERED 25MG DIPHENHYDRAMINE BY IM ROUTE LEFT DELTOID:  NEG CHEST PAIN, BLEEDING, RESTRICTIVE BREATING  B/P 142/80mmHg, O2 sat 99%, HR 101, RR 18 - resolved in 30 minutes sent home feeling better - and to pretreat 25mg Benadryl/20mg Pepcid 30-45minute before second Covid vaccine and to ask for (Name)
In for Menomune vaccine on 07/18/01. On August 4th after he marched in 2 band performances outside, his temperature ranged from 90's-100's. Client became nauseated, chilled, and a severe headache. Went home to bed and temperature at that time was 102.5 headache, nausea; went to ER with parents after long wait was afebrile in ER. Went home and several days later was back to normal.
This spontaneous report was received from a certified medical assistant referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally lot #: L026741, expiration date on 18-MAY-2017; dose was not reported. The vaccines were stored in a temperature of 27F during 15 hours. No adverse events were reported. No previous temperature excursion was reported. No product quality complaint involved. Additional information has been requested.
Hospitalized patient tested positive for COVID 11/15/21. 1 of 2 vaccines given 9/1/21. No documentation of second vaccine.
Right deltoid swollen, warm to touch, pain in arm to leg, achy, no  fever.  Symptoms started  08/02/2005.
Patient received his COVID vaccine yesterday and when he was at school today (11/19/2021) he passed out when he was on his knees and slid under the seat. He was checked by a doctor who then referred him to a Pediatric Cardiologist for evaluation. He was only unconscious for 4 seconds.
pt recv vax 7JUN95 & 8JUN95 pt exp a very high fever; 9JUN95 pt broke out in chicken pox; scars were deep and remained;
Bilateral Antecubital Macular Rash of 5 months duration; slow resolution ; now resolved.  Intermittent palpitations on aerobic exercise for 5 months duration, slow resolution; now resolved.  Periods of vertigo for 4 months duration, now resolved.
Had pain from joints, miserable sitting down, from her hips down had pain and every joint and muscles.  She said that she was not getting a booster.  Approximately 4 months later the pain went away and she was back to normal.  She then got the booster in January and about a month later she had pain from hips on down and this time her upper body had the eczema that started out on her hands, area between the thumb and forefinger and started itching.  She didn't think too much about it and then it spread to the entire top of her hand, and the top of her fingers.  At that point she started using hydrocortisone cream which was recommended by the pharmacist.  She used that on the top of her hands, and it didn't make it go away, but it looked better as it was "bad".  She would use that and would use lotion as it was spreading up her arms.  That did not work, and the itching got "bad", especially in the middle of the night, and then saw a health care provider.  The doctor told her that she knew it was the booster that started it, and that she had never had eczema in her life before and she knew that's where she got it from.  She was informed that she was "spot right on".  She said that she didn't feel that the booster worked as to what she had seen and what she had heard.  She has talked to other people and feels that the booster is not working.  This morning she was picking up leaves early this morning and was talking to somebody and she showed him the eczema and told him about her visit to the doctor and that the booster wasn't working and he said that he had heard that as well.  She is now taking the time to report this as people are going through this and that they are getting sick and the booster is not working.  She is mad now and if she's told she is permanent and has to live with this for the rest of her life, and feels it is horrible if this is permanent.  She cannot go out in the sun as she will burn, and is upset that she is left with this condition.   The eczema is now up to her elbows.    She has never had any issues with eczema of any kind in the past prior to this 1st booster.    She has had two pneumonia vaccines without any problems, and believes that she also got the flu vaccine between the 1st and 2nd vaccines, but did not have any issues with that either and gets her flu shot every year.
Day after second shot woke up with migraine like headache (pounding on both temples and forehead) semi sensitive to light. body aches (felt very heavy)  100.4 degree fever.  drastic temperature variation (very warm to cold)  one nostril congested. very slight sore throat/ cough . self Treatment: slept most of it off after Tylenol and Benadryl.  By late evening aprox 6:30 -7:00 pm headache subsided substantially, body aches almost gone. nose still slightly congested
On 03/25/2023, in the morning, I was achy, congested, then tested twice for COVID-19. I called the doctor's office to report. I developed a fever 101 to 102. The next day, extreme fatigue and coughing and achy. I started PAXLOVID on Sunday 03/26/2023. I continued fatigue and congestion. Fever ceased on Monday. I had trouble breathing at night in a reclined position. Yesterday, 03/29/2023, felt much better but tested positive today.
Information has been received from a health professional concerning a 9 year old male who on 16-AUG-2007 in the AM, was vaccinated with a second SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 658056/0835U). At one hour after administration, the patient developed shortness of breath, hives, and red eyes. Medical attention was sought when the patient returned to the office. The patient was treated with diphenhydramine (HCL) (BENADRYL), albuterol nebulizer, solumeterol, and oxygen. As of 27-AUG-2007 follow up information via telephone cell indicated that the patient was taken directly from the office via ambulance to the emergency room for evaluation and observation because of the treatments he was administered post vaccination. Hospital admission was unknown. The patient's recovery status was unknown. Additional information has been requested.
Hospitalized because of a dehydration; This spontaneous report was received on 03 Mar 2021 from a consumer concerning, a patient of unspecified gender and age, who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized because of a dehydration.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient was hospitalized because of a dehydration. The reporter wanted to know what happens if the second dose of the vaccine is given after the 42 days after the first shot. No treatment information was provided.  Action taken with suspect drug mRNA-1273 was unknown.  The outcome of the event, hospitalized because of a dehydration, was unknown.; Reporter'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.
This spontaneous report was received from a pharmacist via company representative who reported 3 individuals (unknown gender and age) who in approximately 2014 (reported as over the past 3 months) received a dose of ZOSTAVAX (Lot #, exp date, dose and route not reported). Concomitant therapy was not reported. In approximately 2014, the patients were subsequently diagnosed, per unspecified physician, with shingles. It was unknown if the patients sought medical attention. The patient's outcome for shingles was unknown. Follow up information has been received from the pharmacist. The pharmacist stated 2 patients developed herpes zoster after ZOSTAVAX administration. This report mentioned the male patient. On 03-JAN-2013, the patient was vaccinated with ZOSTAVAX lot number: H019035, expiration date: 17-JAN-2014. This is one of the two reports from the same source. Additional information has been requested.
This spontaneous report has been received from a physician referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with VARIVAX (Merck) (Lot#L034372 and expiration date of 08-SEP-2017, Lot#L023594 and expiration date of 26-JUN-2017, Lot#L029472 and expiration date of 06-AUG-2017) that were improperly stored (Incorrect product storage). No adverse effects reported. Additional information is not expected as there is no consent for follow up.
Pt with hx laryngeal cell cancer with chronic trach and peg tube received 2nd covid vaccination on 2/18/21  was admitted to the hospital on 4/7/21  with a late subacute stroke/wife noticed pt suddenly leaning to the left on 3/25/21, possible staph epidermidis bacteremia, concurrent b/l pneumonia requiring ventilatory support, significant rash of unclear cause consisting of bruising and ulcerations> he remains hospitalized in critical care as of 4/16/2021. He is being treated with broad spectrum antibiotics, supportive care, mechanical ventilation, wound care.
Within a day or so of receiving my 3rd Covid vaccine ,  I developed severe dizziness.  This increased to vomiting with movement.  I also had vertigo so severe one day that I passed out and hit my head.  These symptoms took 4 months to improve.  I missed a lot of work, attended PT and am now just getting back to my job as a nurse.  I still have occasional dizziness.  I was worked up by my PCP, Neurologist and ENT.  They all agreed it Vestibular Nephritis from the Covid vaccines
VACCINE LOT NUMBER EXPIRED ON 9/30/22 AND VACCINE WAS GIVEN ON 10/2/22 (2 DAYS PAST EXPIRATION)
Staff went to World Refugee Day to perform COVID19 vaccinations. All 3 vaccines were made available to clients due to boost and prime doses needed.  Baskets for each vaccination were label and color coded. Staff ensured the syringes used for each vaccination were different. Upon returning from the event, the vaccinations were entered into a Mass Event in KYIR. Based on the amount given of each, doses wasted, and amount of vaccine taken to the event, the numbers did not match. Upon assessment into the discrepancy, a few situations were determined to be possible: 1) Two patients may have received J&J that were suppose to get Moderna or Pfizer. 2) Nurses miscounted the amount of doses wasted. 3) Nurses miscounted how many doses were obtained from the vials. Due to the small possibility of two patients receiving the wrong vaccination, this nurse notified the Regional Vaccine Coordinator. The Vaccine Coordinator consulted with the state. The state then spoke with the CDC regarding the possibility and they determined the following actions were necessary: 1) Complete VAERS report. 2) Notify all patients who received the Moderna & Pfizer vaccine regarding the possibility of having received the J&J vaccination. 3) Go ahead and administer the required boost doses on time. 3) Provide J&J Fact Sheet to each recipient of Moderna & Pfizer. Staff completing all of the above steps. An interpreter was used to relay the education and the Fact Sheet was given in the appropriate language. No adverse events have been reported by the recipients. Process changes have been implemented within the clinic. One nurse will be assigned to each vaccine when multiple types are offered. Vaccines will be labeled. Will have patients form lines for each vaccine requested. Nurses will remember the 5 rights to safe medication administration.
The undiluted vial had been refrigerated for a total of 44 days before being reconstituted and administered.   Reasoning: The vial was refrigerated at public health for 20 days prior to being transferred to the hospital. Once received, the vial was refrigerated for 24 days. It wasn't until after administration that the dates were put together and found to be out of Pfizers recommended storage requirements.