chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician assistant via company representative regarding a male patient of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date at the age of 69-year-old, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously, (dose,  anatomical location, lot number and expiration date were not reported) for prevention of shingles. On unspecified date about 1 year after vaccination, the patient got "a very bad shingles outbreak" (herpes zoster). At the time of the report, the outcome of the herpes zoster was unknown. The relatedness between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
pt recvd vax & given PPD test 24June97. Some time p/vax, pt exp rxn of "entire deltoid area red,swollen w/pain & itching".
This is a spontaneous report from a non-clinical study program. A contactable consumer (patient) reported a 65-year-old female patient started to receive XALATAN eye drops at 1 gtt daily for glaucoma on an unspecified ate "for many years"; in addition she received the pneumonia vaccine on 05DEC2014 at the pharmacy. The patient denied having any relevant medical history or taking any concomitant medications. On 12DEC2014, she got the flu after visiting the doctor's office. She was achy all over, in bed for four days, and experienced cough, runny nose/nose blowing, rattle in throat/phlegm in throat, congestion, sneezing and "getting weird". She also commented she was unable to read the small writing on the bottle/box of latanoprost, and was unable to get lot number, exp. date or NDC. The action taken with latanoprost was dose not changed, and with the pneumonia vaccine was permanently withdrawn on 05DEC2014. The outcome of the events was unknown. No follow up attempts possible. No further information expected.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 15-AUG-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J014235 and expiry date: 07-MAY-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
excursion occurred for 45 minutes,max temperature reached 8.9 , excursion occurred for 18 hours 17 minutes and 30 second, refrigerator reached -40.0 C and the patients given the vaccine post excursion with no reported adverse event; Initial information received on 12-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involved excursion occurred for 45 minutes, max temperature reached 8.9 , excursion occurred for 18 hours 17 minutes and 30 second, refrigerator reached -40.0 c and the patients given the vaccine post excursion with no reported adverse event while receiving vaccines meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) solution for injection (lot T1E872M; expiry date: 10-Oct-2022) via unknown route in unknown administration site as Immunization. On an unknown date, patient also received a dose of the same vaccine (lot U1452M, expiry date:20-Feb-2023) via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (lot U7190BA, expiry date: 21-Jan-2023) via unknown route in unknown administration site as prophylactic vaccination.  The caller stated they had an excursion on 15-Ap-r2022 for 45 minutes and the maximum temperature reached 8.9 degrees Celsius. Another excursion occurred on 18-Apr-2022 for 18 hours 17 minutes and 30 seconds. The refrigerator reached -40.0 degrees Celsius and the patients given the vaccine post excursion with no reported adverse event (product temperature excursion issue) (unknown latency) following the administration of IPV (VERO) and (unknown latency) following the administration of meningococcal A-C-Y-W135 (D CONJ) vaccine. It was reported a temperature excursion due to unknown cause and then the caller stated the refrigerator was unplugged. Caller stated they also had ice packs in the refrigerator.  Action taken : not applicable.   At time of reporting, the outcome was Unknown .
5 minutes post Moderna (1st dose) vaccination, pt was standing and booking 2nd dose appt. pt felt dizzy and started to wobble as he was walking to the chair to sit. Pt blacked out, fell on cement floor. Pt was unconscious for 30-40 seconds. Sustained right upper eye laceration, left hand abrasions. BP taken right arm (134/64 HR=62, 100% O2 on room air). Team called at 12:22pm.  pt became conscious Alert and Oriented x4, speaking. +sweating and slightly pale. transferred to ER by ER staff- alert and oriented x4, stood up by himself to bed gurney.
rigors, fever 103, dizziness, nausea, vomitingx1, bodyaches, sore inj site
This spontaneous report as received from a physician via company representative refers to a 16 year old, non-pregnant female patient. The patient's concurrent conditions and medical history were not reported. On 26-AUG-2015 the patient was vaccinated with a first dose of GARDASIL 9 (lot# and route were not reported). The patient reported to physician that following this dose of GARDASIL 9 the expected onset of her next menstrual period was delayed for an unspecified number of days (expected menstrual period start date and actual menstrual period start date were unspecified). The patient experienced abdominal cramping associated with this delayed menstrual period, which she never experienced with any menstrual period prior to receiving GARDASIL 9. The patient e-mailed to physician. There was no treatment given for adverse events and none of lab diagnostic studies were performed. As a result, the patient reported to physician, that she did not wish to continue the GARDASIL 9 series. The outcome of the patient's events was not reported. The relatedness between vaccination with GARDASIL 9 and the patient's events was not reported. Additional information has been requested.
the patient pulled away during the injection and did not get much/ no AE; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 57 year old female patient who received less than 0.5 mL of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatments, vaccinations and family history were not provided.   On 10-Dec-2019, the patient received a dose of less than 0.5 mL suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot QSAA1945, expiry date: 30-JUN-2020] via unknown route in the left deltoid.   It was a case of actual medication error due to Vaccine underdose (underdose). Pharmacist stated that while administering a Flublok vaccine, the patient pulled away, just as he was pushing the plunger. She did not get much, if any of the vaccine.  At the time of report no adverse event was reported.  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.
medial calf muscle injury; muscle pain upon walking; decreased range of motion; decreased range of motion like cannot push off on left foot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 2, single (Lot number: EP6955) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Route of Administration: Intramuscular), administration date: 04Mar2021, for Covid-19 immunization. The following information was reported: JOINT RANGE OF MOTION DECREASED (disability) with onset 04Nov2022, outcome "not recovered", described as "decreased range of motion"; GAIT DISTURBANCE (disability) with onset 04Nov2022, outcome "not recovered", described as "decreased range of motion like cannot push off on left foot"; MUSCLE INJURY (disability) with onset 04Nov2022, outcome "not recovered", described as "medial calf muscle injury "; MYALGIA (disability) with onset 04Nov2022, outcome "not recovered", described as "muscle pain upon walking ". Patient was playing pickle ball when she felt and heard a pop in her left calf. Injury is to the medial calf muscles resulting in muscle pain upon walking and decreased range of motion like cannot push off on left foot. The patient place ice to the area for 20 minutes 3 times a day.  No follow-up attempts are possible. No further information is expected.
patient experienced rash over the upper 1/3 of her body she sought medical attention for it and it was diagnosed as shingles
This case was reported by a pharmacist and described the occurrence of paralysis in a 88-year-old female subject who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. On 8 November 2007, in the afternoon, the subject received unspecified dose of Fluarix at 0.5 ml in the right arm. In the morning, on 9 November 2007 the subject experienced lower extremity paralysis and numbness and tingling in her arms. The subject was seen by her local clinic physician and received no treatment. She was admitted to the hospital on 10 November 2007. The pharmacist considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with Fluarix.
mild case of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (mild case of COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022, the patient experienced COVID-19 (mild case of COVID-19). At the time of the report, COVID-19 (mild case of COVID-19) outcome was unknown.            No concomitant medication information was provided.  Patient received first dose of Moderna in February and second dose August.  Patient received the first two Moderna vaccines 6 months apart way back in 2021. Six months later patient took a Moderna booster in December2021. Patient not had another shot since then. Someone visited patient and husband, they got a very mild case of COVID-19 on 06Sep2022.   No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-675040, US-MODERNATX, INC.-MOD-2022-675038 (E2B Linked Report). This case was linked to MOD-2022-675042 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675040:MOD-2022-675040 (Patient 1 male booster dose case) US-MODERNATX, INC.-MOD-2022-675038:MOD-2022-675038 (Patient 1 male 2nd dose case)
PATIENT RECEIVED 2ND PFIZER VACCINE THAT WAS NOT INTENDED FOR THE AGE GROUP.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown multiple dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L015460, expiry date: 20-JUL-2017 and lot # reported as M013653, expiry date: 26-MAY-2017, dose and route were not reported). The doses were stored under temperature of 60 F for 3 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
On patient (R) deltoid, was given Tdap and MENVEO. Woke the next day with red, swollen, hot to the touch upper arm.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
When receiving vaccine was very nervous and brother held his hand.  Went to sit in observation area and after a few minutes became diaphoretic, pale and claimed he had blurred vision  and muffled hearing. Drank some water and two cans of Coca Cola. NP was present with him. Sat for 1/2 hour and left with brother. Called on 7/30/21 at 4PM and spoke with brother who said his brother was "fine since they left last night".
I tested positive for COVID-19 on 1/6/23. I was sneezing a lot, congestion, cough, loss of taste and smell. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. After two days pf taking PAXLOVID, I felt better. I did have a terrible metallic taste in my mouth from taking the medication. It is gone now though.
My symptoms began approximately 2-3 days after my vaccine. My symptoms mimicked common seasonal allergies so I didn't think too much about it. I began to develop chest congestion, trouble breathing, intense coughing and fatigue. This was a clue that I needed to get tested. First day I found out I was positive, I did have an appointment with my nurse practitioner via virtual appointment. They prescribed the PAXLOVID. This medication has been significant for me. I would compare it to a very bad chest cold. The symptoms are lingering today. I was also on prednisone. I believe the medication has helped me from getting severely sick. The cough has been utterly exhausting. I have been able to work through it. The level of fatigue and exhaustion was extremely high the first few days. The chest congestion is much better today (I am on day 4). The runny nose is still here.
Red, swollen area of upper arm. Tricep area sore into breast area and lower arm.
The pt experienced dizziness, felt like she was going to pass out, with a headache and nausea.
had 2nd Shingrix vaccine 11 am 7/10/19, had a headache at bedtime and took aspirin. By morning 7/11/19, I had an excruciating headache, chills, extreme muscle aches, nausea, extreme tiredness all day; took aspirin, drank a lot of water and took chlorella to try to counteract the reaction. Symptoms were 95% gone by 7/12/19.
Fainted immediately followed by stiffened body, tremors. Body stiffening and tremors lasted for about 45 seconds. Patient started to come to after about three to five minutes. Blood pressure VERY low and began climbing back to normal after about seven minutes.
Admitted from HD with weakness, fever & hypoxia; Covid +; CXR "Low lung volumes with bibasilar subsegmental atelectasis"; Labs: D-dimer 1.11; CRP 6.5; Ferritin 702; Tx Maxipime, Merrem, Remdesivir, Decadron, Vit D3, Heparin, Singulair, zinc ; 2 LPM O2 initially; down to room air at d/c
1-28-2021 - approximately 5pm developed a temp of 101.4 with flu-like symptoms of chills, aches and sore throat .  01-29-2021 patient spend the day in bed due to same symptoms.  Symptoms resolved by 01/30/2021.
Pt recvd vax & devel pain & severe bruising & indicated that 2nd series that pt cannot build up Hep B antibody; titer results remains A;
Severe right eye pain and severe subconjunctival hemorrhage followed by moderate uveitis, corneal abrasion, blurring of vision, increased floaters and flashing. Now one month later. Rx: TOBRADEX ointment QID, DUREZOL drops BID. Vision 80% restored right eye. Flashing continues, Cornea healing.
I had dizziness and severe fatigue with mild headache the first day. The second day my arm was extremely sore and the headache and dizziness were more present. The headache persisted and now it is day 5 and my head is still throbbing. This headache is unlike my migraine headaches and is causing dizziness, pressure, and nausea. The fatigue has resolved, but the headache and dizziness are still just as present as they were the day after my vaccine.
Initial unsolicited report was received via a search of the scientific literature on 03 June 2011. The patient captured in this case was one of eight patients noted in the above reference who experienced anaphylaxis after receiving a diphtheria, tetanus and acellular pertussis containing vaccine (manufacturer unknown). These patients tolerated their initial vaccinations but reacted to booster doses. A four-year-old male patient had received an injection of "DTaP" vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and ten minutes later, he experienced anaphylaxis with symptoms of diffuse hives, and respiratory distress. Corrective treatments consisted of Diphenhydramine and an oral steroid. The patient had a history of asthma and had been diagnosed with a milk allergy based on serologic testing performed to evaluate proctocolitis from cow's milk-based formula at three months of age. Laboratory testing showed the patient had increased IgE levels (82.9 (kIUA/L) within two years of vaccination. Outcome was not reported. This case was considered as serious by the reporter due to medically significant events. Follow-up information received 24 August 2011 from a physician who stated that they did not administer the vaccine to the patient. The patient was vaccinated by their primary physician; therefore, the reporter was unable to provide information pertaining to the name of the vaccine manufacturer, lot number, site and exact date of administration, symptom duration and stop dates/times, and specific medication dates and dosages received as treatment. No additional information was provided at the time of the report. This patient had previously been referenced in case number 2011-01614. The other seven patients have been captured in case numbers 2011-03275, -03276, -03277, -03278, -03279, -03280 and -03281. Follow-up information received from a physician on 06-Mar-2017. This case was found duplicate of case number 2016SA073837. Hence, case 2016SA073837 was deleted. The patient was vaccinated with booster dose of DTaP vaccine. List of documents held by sender: none.; Sender's Comments: Follow-up received on 06-MAR-2017, does not change the previous assessment of the case, Manufacturer of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE was not reported. Anaphylaxis is reported after administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. Time to onset 10 minutes is compatible with the role of the vaccine. In the study it has been observed that the patients who have cow milk allergy are more prone to the reaction after administration the diphtheria, tetanus and acellular pertussis vaccine. The presence of casein of the Tdap and DTaP vaccines may increase this risk. According to the provided information the role of the vaccine could not be ruled out.
Pt admitted 7/22 at unknown active phase labor. Pt having nausea, vomiting (one or twice a day) and diarrhea- loose stool once per day since yesterday. Pt states she feels sick. 7/22 COVID+. 7/23 Private was called to evaluate pt for bradycardia, and hypotension. Pt had spontaneous vaginal delivery 7/22, with no complications.  She has no abnormal bleeding noted.  She denies any dizziness, lightheadedness, chest pain, or shortness of breath. Noted temp of 102.2 taken, follow up temp after blanket removal 99.4. Pt notes that room felt warm to her, denies feeling feverish, chills or sweating. 7/24 No new complaints; feeling much better; temp down. No chest pain/palpitations. Pt discharged.
Area of redness around injection site, approximately 1.5 inches x 2 inches. Area is sore. Not seeking treatment at this time.
Fever, chills, all-over body aches starting ~12hr after injection and lasting 24+ hrs. Fever remains at 48hr but body aches are gone. Injection size is warm, tender, and bruised. Extremely low blood pressure at 48hr caused me to nearly faint and to sweat profusely.
No additional adverse effect reported.; ROTATEQ, M-M-R II and VAQTA that underwent a temperature excursion were administered.; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 25-MAY-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # 1707591, expiration date reported as 10-MAR-2022, but upon internal validation established as 11-MAR-2022) (exact dose not provided) for prophylaxis. The administered dose was stored in temperature above 46 Fahrenheit degrees (F) (46.8 F) for 30 minutes. No previous temperature excursion occurred. Digital data logger was involved. No additional adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA006607: US-009507513-2106USA003900: US-009507513-2106USA003899:
hard breathing; Dizziness; cannot control herself when standing.; This is a spontaneous report from regulatory authority program . A contactable reporter (husband) reporting for his (wife) female patient reporting that:  A female patient of an unspecified age received bnt162b2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 18Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine bnt162b2 on 28Mar2021 as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced hard breathing, dizziness and cannot control herself when standing. The outcome of the events unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Extreme fever chills. Unknown if actually had fever. Chills were so violent hot shower could not subside them. Slept under 4 blankets until I sweated it out. Approximately a 60 minute episode.
the patient received an expired dose of pfizer.  They only had a sore arm from the administration. patient was re-vaccinated on 10/3
Had FLUMIST on Oct 19. On Oct 19 started feeling hot and on the Oct 20 the right side of face felt tingly (like novocaine wearing off) tingling increases and decreases. Oct 21 the right fore finger and left big toe feel tingly and forefinger also feels numb.