chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received Act-Hib after the expiration date printed on the carton 07Apr2023 but the powder vial that they scanned had an expiration date of 28May2023 with no reported adverse event; Initial information received on 08-May-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 1 years old male patient who received HIB (prp/t) vaccine [act-HIB] after the expiration date printed on the carton 07apr2023 but the powder vial that they scanned had an expiration date of 28may2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination.  On 10-Apr-2023, the patient received 0.5 ml total dose 4 of suspect HIB (prp/t) vaccine Powder and solvent for solution for injection (batch number- UJ679AAA/UJ667ABA and expiration dates- 07-Apr-2023/28-May-2023/15-May-2023) via intramuscular route in the left thigh (strength: not provided) for Immunization.  On 10-Apr-2023 the patient received act-hib after the expiration date printed on the carton 07apr2023 but the powder vial that they scanned had an expiration date of 28may2023 with no reported adverse event (expired product administered) (latency- same day) following the administration of hib (prp/t) vaccine.  It was reported that they have 2 boxes of ACT-HIB where the lot numbers on the carton and powder vials match, but the expiration dates on the carton and powder vials do not match. The office manager also reports that due to this, 1 patient received ACT-HIB after the expiration date on the box; asks what they should do.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.  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 guidelines. 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.
Pain, redness, numbness and tingling the next day. Pt given MOBIC 15 mg 1 dly. Advised to apply ice and rest arm. No work 9-22-09 and 9-23-09.
Vaccine received at 3:00 PM on 1/4/2021 10:00 PM: fatigue 1/5/2021: 01:45 AM: Fever 104 F, Chills, Body aches, headache, severe pain in arm of injection. 04:00 AM: Fever 101 F  08:00 AM: Fever 100.4 F. Tylenol taken. Headache and body aches throughout the day. 1/6/2021:  headache and body aches most of the day ALL Symptoms gone by 48 hours post vaccine
body pain; shiver; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Nov2021 19:00 (Lot number: FH8028) at the age of 41 years 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: PAIN (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "body pain"; CHILLS (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "shiver". Therapeutic measures were not taken as a result of pain, chills.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since vaccination, the patient had not been tested for covid-19. No known allergies. Device date: 06Nov2021.  No follow-up attempts are possible. No further information is expected.
SORE ARM SLIGHT NAUSEA FIRST DAY. HEADACHE SECOND AND THIRD DAY Narrative:
Sore arm, mild body aches, mild joint pain.  Aches and pain resolved in 24 hours after onset
Swelling/Mass Supraclavicular lymph nodes, large knot and swelling at injection site that started today 1 week post vaccination.
Petite mal seizure after vax. Rigid body, moaning, unresponsive total time 4 min from unresponsive to full alertness. Transfer to ER.
5-6 cm edema, erythema at site of injection, refusal to bear weight on affected leg for 24 hrs.
patient had red, hot swollen at injection site and pain down left arm; patient had red, hot swollen at injection site and pain down left arm; patient had red, hot swollen at injection site and pain down left arm; patient had red, hot swollen at injection site and pain down left arm; Initial information regarding an unsolicited valid non-serious case was received from a physician  via the agency (Reference number- 00328036) and transmitted to Sanofi on 22-OCT-2020.  This case involves a 26 year old female patient who had red, hot swollen at injection site and pain down left arm  (vaccination site pain, vaccination site swelling, vaccination site erythema and vaccination site inflammation), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  On 20-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (form :prefilled syringe, lot number and expiry date not reported) via an intramuscular route in the left upper arm for prophylactic vaccination.  On 20-Oct-2020, the patient developed a non-serious patient had red, hot swollen at injection site and pain down left arm (vaccination site pain, vaccination site swelling, vaccination site erythema and vaccination site inflammation) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data was not reported.  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the patient was recovering from events.  There will be no information available on the lot number for this case.
This spontaneous report has been received from the patient's mother (reported as an "office manager"), via a company representative, referring to her daughter, whose age was not specified. The patient's pertinent medical history, concomitant medications taken by her and information about her drug reactions or allergies were not provided. On 08-JAN-2013, the patient was vaccinated with the first dose of GARDASIL for prophylaxis (concentration, dose, frequency, route and anatomical location of administration, lot number and expiration date were not provided). It was reported that the patient did not experience any adverse event then. Later, on 07-AUG-2013, the patient was vaccinated with the second dose of GARDASIL for prophylaxis (concentration, dose, frequency, route and anatomical location of administration, lot number and expiration date were not provided) (inappropriate schedule of drug administration). It was reported that, on an unspecified date after receiving the second dose of GARDASIL, the patient experienced "severe body aches (pain), vomiting, high fever (pyrexia) and body shakes (tremor)". The company representative stated not being sure about pain, vomiting, pyrexia and tremor being previously reported. In addition, the company representative mentioned that, at vaccination time, the patient's physician was "Dr."; however, "he no longer practiced at the clinic and there was no contact information for him". Further information was not provided. At reporting time, the outcome of pain, vomiting, pyrexia and tremor was unknown. The office manager did not provide any causality assessment for pain, vomiting, pyrexia and tremor in regards with GARDASIL vaccination.
7cm x 7cm erythmic, nontender area around injection site. Left thigh.
This spontaneous report as received from a pharmacist via other company (Pfizer manufacturer control number 2014282049) refers to an elderly male patient (>65 years). The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (route, lot number and expiration date were not provided); and at same time patient received a dose of PREVNAR 13 (route, lot number and expiration date were not provided). The pharmacist stated that then he read that it should be given spaced apart and queried what were the ramifications of giving at same time. No further information was provided. Additional information has been requested
About a half hour after the vaccination I got stomach pains and a headache which lasted until 1/21 and all symptoms subsided with no new symptoms
Very soon after receiving the vaccine, my arm began to feel very sore and a bruise appeared to the side of the injection site within an hour. Over the course of the next few hours, the arm became significantly more sore to the point that I could not use it for many actions, especially those involving raising the arm or pulling (as in pulling up my pants after using the toilet or even using toilet paper). The arm also felt hot and throbbing with a burning sensation. The bruised area became puffy. The injection site seemed to be very high on my arm, close to the shoulder bone.
starting Saturday afternoon 6/6 arm itchy, red, swollen, warm to touch mid upper arm, saw Dr Monday 6/8 and got antibiotic doxycycline to treat cellulitis
Janssen COVID-19 Vaccine EUA I got swelling and considerable pain at the injection site. The swelling started growing and started giving itching sensation. Right now, I have 2inch by 1 inch size clot with reddish skin and swollen. And I feel numbness or soaring feel in the left arm. I am heading to an in person doctor visit to understand more on this problem.
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 12-AUG-2013, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J000141 and expiry date: 04-JUL-2014) 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.
No additional AE reported; Medical assistant reported ROTATEQ was administered to a patient after a temperature excursion. No further information provided. No additional AE reported. No PQC reported.  Name of vaccine involved (including lot/exp): ROTATEQ (W000381, Apr 13, 2023; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, allergies and drug reactions were not provided.  On 19-SEP-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered once, lot #W000381, expiration date: 13-APR-2023, (strength, dose and dose number were not provided) for prophylaxis (product storage error). The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion of 48.4 Fahrenheit (F) degrees for 2 hours. It was reported that previous temperature excursion for the suspect vaccine did not occurred. No additional adverse event (AE) was reported (no adverse event).
NOTE: the adverse effects were experienced sequentially between April 18- June 30, 2021 1) April 18-26, 2021: itching in both hands; prescribed benadryl @ 25mg, 2 pills nightly AND tagamet@ 200 mf daily; symptoms alleviated by April 26, 2021 2)April 27, 2021: slight nausea and upset stomach 3) April 28, 2021: muscle ache in shoulders only 4)~ April 29- May 3, 2021: muscle aches in both legs and arms. Intensity increased to pain level 9 on scale of "1- 10"; Treatment medications given at hospital emergency room: iohexol, ketorolac, and naproxen 5) ~ May 1, 2021: shortness of breath 6) ~ May 1- June 30, 2021: fatigue
Patient received flu vaccine in LA and same day got a bruise - bruise continued to grow along and around injection site - patient showed pharmacy 10/12 - patient said looked better.
Mastocytosis symptoms; flare up of Mastocytosis; A spontaneous report was received from a nurse who was also a 90 years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced a flare up of mastocytosis symptoms (mastocytosis and condition aggravated).  The patient's medical history included mastocytosis. Products known to have been used by the patient, within two weeks prior to the event, included cimetidine and diphenhydramine hydrochloride.  The patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A), intramuscularly, in the left arm on 30 Dec 2020 for prophylaxis of COVID-19 infection.  On 02 Jan 2021, 48 hours after vaccination, the patient went to the emergency room (ER) with mastocytosis symptoms including low grade hives, increased heart rate, burning sensation and heat on the skin. The patient had a long history of mastocytosis and carried an ephedrine and diphenhydramine hydrochloride. The ER physician thought the vaccine caused flare up of mastocytosis. The patient was given diphenhydramine hydrochloride and methylprednisolone and sent home.   A few days later, the patient had another episode of the same symptoms and went to the ER again on 15 Jan 2021. The physician recommended the patient wait and not get the second shot which was due on 28 Jan 2021.   Treatment for the event included diphenhydramine hydrochloride and methylprednisolone.  The second dose of mRNA-1273 was temporarily withheld in response to the event.   The outcome of the event, flare up of mastocytosis symptoms, was not reported.; Reporter's Comments: This is a 90 year male patient with relevant medical history of mastocytosis which is a confounding factor that may a play contributory role providing an alternative explanation. Further information is requested.
The patient contacted the PCP office stating she has had arm pain since the date of the immunization "like she was punched in the arm", was nauseated the evening after receiving the immunization but has not experienced the nausea since that evening, and noticed a swollen, reddened area, 1 inch in diameter, surrounding the injection site this morning, 11/16/10, that is warm to the touch.  She said the redness has lessened since initially noticing it this morning.  She denies fever, numbness, or any drainage from the injection site.  The patient was told to use cool compresses on the site, antiinflammatories, and offered an office appointment or labs.  She said she will watch the area and if anything changes she will call to schedule the appointment or to have the PCP order labs.
Took shower, felt nauseated, walked over to sink and tried to vomit but didn't. Next thing woke up on floor, had hit head (bump) and left arm from elbow to pit was bruised too.  Went to bed. Next day had an extreme head ache and kept hurting for a whole week. Went to ER on day 6.  At ER blood pressure was extremely high. 222/100?. They took a CT scan of my head and found no signs of TIA/Stroke but possible mild/moderate concussion.  After blood pressure was down to 154/70? I was allowed to return home with hydrocodone and ondanesetron. After third day didn't need to take the hydrocodone or ondansetron.
101 degree fever, fatigue, arm soreness and weakness, muscle aches, and headache Took acetaminophen after about 24 hours All symptoms lasted for about 36 hours, except arm soreness/weakness which lasted for about 72 hours
The patient was given a dose of the undiluted (Gray cap) Pfizer COVID-19 Bivalent booster that was not stored in an ultra-cold temperature freezer and was instead stored in the regular freezer (between -30 to -20 F). It was moved out of the regular freezer to the refrigerator after more than 3 weeks in the regular freezer. The doses were then used after more than 24 hours in the refrigerator. We have contacted Pfizer about this and according to their off-label studies they provided via file, they are not able to support the temperature excursions that occurred. As per CDC guidance, the recommendation is to re-vaccinate the individual with the full authorized dose of any Bivalent vaccine (either Pfizer or Moderna) and we have communicated with the patient for re-vaccination.
I woke up Tuesday, the morning following injection, to get ready for work. I got  my coffee, and felt very lightheaded and fuzzy. I sat down on the bed. Everything began to get dark and fuzzy, I felt like I was going to throw up. I tried to call out for my husband, but I didn't think I got his name out. The next thing I remember my husband was holding my and yelling at me, trying to get me to respond. He reports that he heard me call his name, he came into the bedroom to find me stretched out, stiff as a board, with my head cocked all the way back, tongue sticking out of my mouth, and unresponsive. He picked me up and my body remained rigid. After a minute and a half, I came out of it extremely confused. I did not know where I was or if it was real or a dream. He ran me to the hospital across the street from our house. I was admitted to the ED where I received IV fluids, an EKG, CT scan, and blood work. They do not know why it happened to me, but agreed it was possible I had experienced a seizure in reaction the the vaccine I received less that 24 hours prior.
Information has been received from an immunization official healthcare worker referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with RECOMBIVAX HB (dose, frequency, route and lot# were not reported), which were stored improperly. No adverse effects were reported. This is one of three reports received from the same source. Additional information has been requested.
Allergic reaction; This non-serious case was reported by a physician via call center representative and described the occurrence of allergic reaction in a female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Menveo (had a dose in 2017 and tolerated it).   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced allergic reaction (Verbatim: Allergic reaction). The outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Havrix.     It was unknown if the company considered the allergic reaction to be related to Havrix.   Linked case(s) involving the same patient:  US2023AMR046638   Additional Information: GSK receipt date: 27-MAR-2023 The reporter was an allergist. The reporter reported that a patient who had an allergic reaction to Havrix in 2020 and was due for a Menveo booster in 2023.  The reporter enquired about any contraindication to having Menveo because of the reaction to Havrix, similar components and the ingredients of each vaccine. The follow up would not be possible as no contact details were provided. This case was linked with US2023AMR046638 reported by the same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR046638:Same reporter
Symptoms - ? EE reports beginning at approximately 19:00 (1/7) chills and myalgias.  EE reports she tossed and turned last night so woke up feeling pretty tired.  EE reports today she feels okay minus feeling a bit tired.  EE denies fever, COVID-19 exposure without proper PPE and recent travel.   Last day of work and shift - ? unknown Home remedies? -   none Any improvement? - yes Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns.  EE verbalized back understanding and denied further questions at this time.
My pap was bad within a month of the last injection; I had a horrible reaction to it; This spontaneous report was received from a consumer, from a media report, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On an unknown date, when she was 26 years old, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis. After vaccination, the patient had a horrible reaction to it  and went through 2 years of colposcopies every 3 months because of this vaccine (vaccination complication). Additionally, her pap was bad within a month of the last injection (smear cervix abnormal ).  At the reporting time, the outcome of smear cervix abnormal and vaccination complication was unknown. The reporter did not give the causality assessment between events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Seizure-like symptoms for around 3 minutes. Struggled to breath, move, talk, intense pain in chest and head. Fever and headache for several days after.
Expired vaccine given to client on 09/08/22 and vaccine expired 08/31/22. No adverse symptoms occurred that  day of vaccination or thereafter that I am aware of. Contacted client of expired vaccine given.
Dizziness. BPs 146/93 (pulse 90), 130/74 (pulse 96). Given water, juice, crackers.
miserably sick; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a patient (demographics unknown) who was miserably sick (illness) when received INFLUENZA VACCINE.  It is unknown if the patient had any medical history, concomitant disease or risk factor  Medical treatment(s), past vaccination(s) and family history were not provided   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was miserably sick (illness) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  The patient received vaccine for 3 years and got miserably sick for 2-3 weeks each time. The patient stopped getting the shot and it has been over 30 yrs. It is different on each individual   It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available   It was not reported if the patient received a corrective treatment.  At the time of report, the event recovered.  There will be no information available on the batch number for this case
Nausea, headache, fatigue, body aches, fever 102.7, and rash around arm.
vaccine was administered after the short dated expiration date of 4/28/21.  No adverse event reported by pateint.
About 3PM 15NOV91 pt cried for 1hr w/out stopping no other problems;
The injection site still feels tight/pressure. Swollen glands in the neck the size of a golf ball. Neck is sore - pain causing headaches. Extremely tired and fatigued throughout the day. Nauseous throughout the day.
hemorrhagic bleeding (period), blood clot via bleeding. 1 week of bleeding, required transfusion cbc/esr/crp. now have +factors for antiphosophlid syndrome along CCP. along w/ joint pain in her right hands, fingers and right knee. have swelling to the fingers.