chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 patient on 18OCT2021 has received the expired IPOL with no reported adverse event; Initial information received on 18-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional and non health care professional via Medical Information (MI) number: 00816606.  This case involves a 10 years old female patient who was administered an expired dose of  POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.   On 18-Oct-2021, the patient received a 0.5 ml  dose of suspect IPV (VERO) lot number: R1F971M and expiry date: 03-OCT-2021  via intramuscular route in the right deltoid for site prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, 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 the 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.
20 minutes after receiving the shot, my throat became tight and uncomfortable, and I felt like something was stuck in my throat. I was constantly trying to swallow to make the sensation go away. The throat tightness lasted but became progressively better for about 4 hours, until about an hour after I took 50mg Benadryl, when it went away completely.
Pt stated she "did not feel well" after receiving TD vaccine. She felt tingling in arms, heart rate increased, BP increased, Benadryl administered and 911 called.
minimal initial react, sl pain @ inject site only on day of immun confirmed SID's 11APR94;
Moderate pain in shoulder, swelling of shoulder, redness, feverish at site, itching.
12/13/21 14:30 began fever and chills (intermittent, not fully resolved)   12/14/21 Swelling to right side of face (18:30) Severe swelling to bottom lip (19:15) Swelling to jaw/under the chin (19:30) Pain in jaw/inability to fully open mouth (19:00) Pain to lip/gum line of bottom teeth (17:00)  10/15/21 Facial twitching to right eye/cheek (resolved) (lasted 04:00- approx. 08:00)  Self started taking Tylenol Urgent care visit. Started a course of Augmentin, a course of Prednisone, continue Tylenol, and heat compresses. Self monitor for airway involvement.
the next morning woke and was chilling/shaking with fever. Horrible aches all over body, terrible headache,. extreme thirst. The fever and chills lasted 2 days but the all over body pain was at least 4 days. I missed a full week of work. Severe pain in my arm wear the shot was given.
no adverse event; improperly stored; This spontaneous report as received from a medical assistant referred to a patient of unknown age and gender. The patient concurrent condition, medical history, concomitant therapies and drug reactions/allergies were not reported.     On 12-APR-2019, the patient was vaccinated with one dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # R013859, expiration date 14-JUN-2019) (dose, unit and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. Temperature: 35.42F. Time frame: 18 minutes. There was no previous temperature excursion.; Sender's Comments:  US-009507513-1904USA008552: US-009507513-1904USA008551: US-009507513-1904USA008553:
This Covid "booster" Monovalent was given inadvertently as a booster dose to the adults instead of a bivalent dose. The label read "booster" and caused some confusion. We ordered the Bivalent dose and this primary series for 6-12/adult boosters arrived instead.The cap colors are the same. Labels look almost identical except for the boarder color. Suppose we re-label, change label colors/cap colors to prevent this from happening again?
Rash starting behind ears, moving to neck and trunk. Patient took a 2nd generation antihistamine (unsure which one) and this has helped with the itching. Rash is still present.
After pt received first dose of Moderna on January 27, 2021, he experieced continuous increased decline in his health , with symptoms of increased difficulty swallowing, increased coughing, at least one episode of choking with expulsion of food; increased difficulty walking with walker, increased shortness of breath. On Wednesday, Feb. 24,  at 7:50 a.m. , Pt was in wheelchair exiting home, on way to detached garage, being pushed by his daughter, when he slumped over, stated that he couldn't breathe, and went unconscious.  Pt. did not have a detectable pulse . EMT was called and upon arrival performed CPR  and obtained a pulse. Pt was transported to local hospital, where, again he lost pulse and was resuscitated again with mechanical CPR.  Pt was supported with blood pressure medicine and ventilator until 7:53 p.m. when his heart stopped again.  Pt. passed at that time.
Patient received PREVNAR vaccine (PCV13) on 4/9/14. On 4/12/14, he developed a raised itchy reddish rash all over his body. He sought care from the ED on 4/23/14. In the ED, patient reported use of a new soap starting on 4/11/14. Per ED doctor note, diagnosis was dermatitis- most likely reaction to new soap. Patient was instructed to stop new soap and was given prednisone 40mg x7 days and cetirizine 10mg PRN x20 days. Although rash was likely caused by new soap, there remains a possibility that PREVNAR could be the causative agent. Patient reported feeling a lot better during telephone follow-up on 4/24/14. Patient received PNEUMOVAX (PPSV23) on 5/7/14. As of 5/10/14, no reported signs of allergic reaction to vaccine, decreasing the likelihood patient had reaction to PCV13 vaccine.
I experienced a swollen scratchy throat 30 minutes after I received the vaccine which I took Atarax for. Began feeling fatigue, arm pain, headache, and chills. Woke up at 9pm with a fever of 104, shivering, chills, headache, body aches, and I had to alternate between Tylenol and Advil to keep the fever down. I had to miss work for 4 days, because the symptoms had not abated. 2 days from vaccination a rash developed starting from the injection site and progressing to my whole body by the next morning. The rash stayed for 10 days, and the fever resolved after 7 days, the chills and body aches resolved after 7 days. The symptoms have all resolved.
Began 1st day after 2nd injection with pain; Swelling at injection site; Heat at injection site; Redness at injection site; Itching began on day 2-3 with pain slowly subsiding; Itching began on day 2-3 with pain slowly subsiding; This is a spontaneous report from a contactable consumer (reported herself) A 58-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 07Aug2021 16:30 (Batch/Lot Number: EW0179) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included glaucoma, thyroid disorder. Concomitant medications included liothyronine sodium (CYTOMEL), atorvastatin calcium (LIPITOR) levothyroxine sodium (SYNTHROID). The patient previously took penicillin nos for hypersensitivity and historical vaccine included bnt162b2 lot number: EW0179, first dose for covid-19 immunisation with no reaction. The patient experienced pain at injection site on 08Aug2021 04:00 with outcome of not recovered, swelling at injection site on 08Aug2021 04:00 with outcome of not recovered, heat at injection site on 08Aug2021 04:00 with outcome of not recovered, redness at injection site on 08Aug2021 04:00 with outcome of not recovered, itching began on day 2-3 with pain slowly subsiding on 08Aug2021 04:00 with outcome of not recovered. No treatment was done.  Follow-up attempts are completed. No further information is expected.
Pt was given 1cc of flu vaccine instead of 0.5cc vaccine.  Pt notified of possible vaccine response.      No adverse reactions known.
a 12 year old patient received a dose of Flubok, no AE; Initial information received on 03-Dec-2019 regarding an unsolicited valid non-serious case received from Non-HCP (Office Staff).  This case is linked to case 2019SA337479 (same reporter).  This case involves a 12 years old patient (gender not reported) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  It was reported that nurse gave the Flubok to 12 year old patient.  At the time of reporting no adverse reaction 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 and Module VI of the 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.  Information on the batch number was requested.
Client noticed she developed an area of redness approximately 2" long x 1 in wide at site of YF vaccination. Did not feel bad after vaccinations received. Pointed out to nurse on 6/25/13 visit when here with sons.
Nausea, vomiting, diarrhea and fever starting the night of the vaccine and lasting for 3 days. Fatigue, weakness and axillary lymphadenopathy starting over the first 24 hours and still persisting today, 4 days later.
PREVNAR (Lot 88275) administered in left deltoid, patient presented the next day with soreness, 4-5 cm erythematous round area about the injection site, central pallor mild induration and warm. No swollen, tender lymph nodes, temp 99.9, no systemic symptoms.
Pt recvd 3 doses of Engerix-B vax 10NOV90, 7DEC90, 29APR91 & 14SEP91 it was determined that pts titer was neg p/3 doses of Engerix-B;
immobilized  left arm.; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was unknown.   The reporter considered the mobility decreased to be possibly related to Shingrix.  Additional Information: GSK Receipt Date: 04-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had Shingrix vaccine and immobilized his left arm. The reporter thought that, the event might had been related to the drug. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Information has been received from a consumer concerning his/her 17 year old daughter, with no pertinent medical history and no drug reactions or allergies, who on 13-SEP-2010 was vaccinated with the first dose of GARDASIL (lot # and expire date not reported), intramuscularly. There was no concomitant medication. The patient was unknowingly pregnant when she received her first dose of GARDASIL. On 13-SEP-2010 the patient had miscarried. On 18-NOV-2010 the patient received her second dose of GARDASIL (lot # and expire date not reported), intramuscularly. There were no laboratory diagnostics studies performed. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. Upon internal review, miscarried was considered to be other important medical event. No further information is available.
headache, chills, fatigue, nausea starting 1-2 hours after vaccine dose and lasting 7 days
On 3/27/21 this patient came to a COVID Vaccine clinic at our health center at that time the person may have received a dose of Pfizer vaccine diluted with Sterile Water rather than the saline solution diluent from the manufacturer. Our office was shipped 26 vials of vaccine and 25 vails or diluent as the State DOH reported there was a diluent shortage at the time. Under the direction of the stage DOH the sterile water solution was used. Later we were contacted to report this to both the patients and VAERS by the state DOH, as they later questioned their original desecion.  The were 30 to 36 doses drawn with this solution and this person is 1 of 72 others who may have had a dose of this mix
Information has been received from a physician concerning a 67 year old male who on 3/8/03 was vaccinated with pneumococcal vaccine 23 polyvalent. This was the second dose. The first dose was administered 5 years ago, when patient had 62 years. On approximately 3/8/03 the patient experienced arthus-type reaction with the following symptoms: high fever, oedema on arms, local induration. It was reported that the patient presented fever only at the day of vaccination. The patient went to the hospital and the physician that attended diagnosed cellulitis streptococcal but the reporter physician did not agree. The patient was hospitalized for 3 days (hospitalization start and finish date are not clearly reported), during the hospitalization the patient did not have a fever. Additional information is not expected.
Monitored patient for 15 minutes without reaction. She left the clinic and on her drive home started having numbness in lips and face,only L side, noticed small lump in L side of throat. On arrival at Seminole ED she received a "steroid injection" and was instructed by medical professional to take a oral Benadryl once she was home. She was alone and driving herself. No other treatment or extended observations necessary.
approx 1hr p/vax pt devel hives, itching of palms of hands, tightness in throat & wheezing;took DPH & sx gradually resolved in 2hr;
Rapid heart rate over 143, high blood pressure 247/100 and something, hard to catch my breath and felt weird. Onset within 5 minutes. Lasted greater than 30 minutes.
temperature excursions due to refrigerator failure; This case was reported by a nurse via sales rep and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Shingrix, Boostrix, FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Shingrix, Boostrix, FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter disclosed temperature excursions for vaccines Shingrix, Boostrix, FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device due to refrigerator failure, which led to incorrect storage of drug. The reporter consented to follow up.
Patient stated swelling to pit arm started on 11/9/05 at 10:30am with pain that time. Swelling with rash and minimal pain noted to right arm today 11/10/05. Parent adverse to seek care w/dr if S/S persist. Parent informed nurse she will keep me updated.
This spontaneous report was received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. Patients' pertinent medical history, drug reactions/allergies or concomitant information were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly storaged VARIVAX subcutaneously, lot # L010148, expiration date: 24-MAR-2017 (strength and dose were not provided). No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: found pt on floor in front of pharmacy dad said he fell but pt was conscious alert and oriented (spelled his name and follow commands, raised both legs) vital signs rr=24, pulse =83, bp= 117/70 . Per father did not hit his head. At 12:46, bp 96/64, HR =81, o2 sat =100%, HR =77, RR =21. Pt stated he "feels better" AT 12:59 pt O2 sat =100%, HR=84, RR =22, BP 98/65 patient says he feels better and dad agree to take him home and F/U with his MD. At 1:10 pt and father left pharmacy
administration of improperly stored ROTATEQ; This spontaneous report was received from an unspecified reported (Other) and refers to a specific patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 17-JUL-2023, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, dose 2 milliliter, lot #1968392, expiration date: 24-MAY-2024, administered orally for prophylaxis (strength was not provided) (Product storage error).   Temperature excursions were reported as follow: 20-JUN-2023: 34.9 Fahrenheit (F) for 6 hours 34 minutes 0 seconds 03-JUL-2023: 51.4 F for 7 hours 33 minutes 0 seconds 04-JUL-2023: 51.1 F for 24 hours 0 minutes 0 seconds 05-JUL-2023: 50.7 F for 9 hours 27 minutes 0 seconds Time frame: 34.9 F for 6 hours 34 minutes 0 seconds; 51.4 F for 7 hours 33 minutes 0 seconds; 51.1F for 24 hours 0 minutes 0 seconds; 50.7F for 9 hours 27 minutes 0 seconds. There was no previous temperature excursion.  This is one of multiple reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA009292:mother case US-009507513-2307USA009885:
Got the vaccine on Feb 17, 2021 at 9am. On Feb 18 at around 8:30-9 pm, left cheek started feeling uncomfortable and a bit swollen. The next morning, swelling was extreme and extremely painful to touch. It was difficult to eat from left side and to laugh and talk. Also, had chills and felt weak.  I scheduled an online appointment with Dr.  he mentioned the condition is called acute pericoronitis and he suggested that vaccine might have increased the immune response to any infection that might have happened underneath the left wisdom teeth which hasn't come out yet. [Note: Same response had happened when I got my MMR vaccine on Feb. 1, 2021]. He prescribed Amoxicillin 500mg for a week.  As of Feb 22. 11 pm, after taking Amoxicillin and ibuprofen, the swelling has bit reduced but the pain persists.
Itching around the injection site   red rash on upper arm    some swelling an warm around the injection site
Both doses have caused irregularities in menstrual cycle(bleeding and early period); Both doses have caused irregularities in menstrual cycle(bleeding and early period); Headache; This is a spontaneous report from a contactable consumer. This 29-year-old female consumer (patient) reported that she received bnt162b2, dose 1 via an unspecified route of administration on 12Jul2021 (Batch/Lot number was not reported) in right arm as SINGLE DOSE for covid-19 immunisation at Pharmacy or Drug Store (also 29-years-old when receiving vaccine). The patient medical history included Complex partial focal epilepsy and birth control. The patient concomitant medications include Probiotic, Womens multi, deblitane. In Jul2021, the patient experienced irregularities in menstrual cycle(bleeding and early period), Heavy menstrual bleeding and headache. The outcome of the event Both doses have caused irregularities in menstrual cycle(bleeding and early period) and Heavy menstrual bleeding was not reported and that of headache was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Pt experienced dizziness, chest tightness. Vitals checked, BP/HR/BG all normal. Pt agreed to 12.5mg oral diphenhydramine x1.
In the middle of night on day of vaccination I had a fever and chills and GI issues and a headache. It resolved around 11am the next day. On 10/03/21 I did get COVID-19. Dr. gave me the Zpack and prednisone and the regeneron infusion. I was out of work for 2 weeks with COVID-19.
pt recvd vax 10AUG93 & subsequently pt devel a ruptured disc, flu-like sx, h/a, gallbladder disease; weight dropped 39 pounds in 3 wks; pt was hospitalized; nurse felt that there was a problem w/the particular lot of vax;
Told her not get the second dose of the vaccine; Doctor told her she had a bad reaction to the first dose; Partially paralyzed for about 4/5 hours on her bottom half; Little bit itchy  hair, ears, and eyes; A spontaneous report was received from a consumer concerning a 78-year-old, female patient, who experienced partial paralysis on her bottom half/paralysis, bad reaction to the first dose/vaccine complication, not to take second dose/ intentional dose omission, itchy- hair, ears, and eyes/pruritus.  The patient's medical history included COVID-19 in Dec 2020 and high blood pressure.  Products known to have been used by the patient, within two weeks prior to the event included high blood pressure pills.  On 09 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 036A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 10 Mar 2021, the patient was partially paralyzed for 4-5hrs on her bottom half. The patient had same symptoms when prior exposed to COVID-19 in Dec 2020 and experienced little itchy- hair, ears and eyes. Brain scan, lungs, heart, blood tests and neurological functions were tested when patient consulted a health care provider (HCP) hence was advised not to take second dose.   Treatment for the event included Benadryl.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, partial Paralysis on her bottom half/Paralysis was recovered.  The outcome of the events,bad reaction to the first dose/vaccine complication, not to take second dose/ intentional dose omission, itchy- hair, ears, and eyes/pruritus were considered 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 events, a causal relationship cannot be excluded.
Awoke at 2:30 AM morning after admin with chills, sweats & generalized aches. OK during day. Awoke next morning 4:30 AM with same symptoms. Took APAP.