chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in my arm at the injection site, pain/burning along a vein leading up to left side of my neck and shoulder, swelled lymph node along my  left collar bone, 3-4 smaller swelled lymph nodes along my left  shoulder cap, fatigue , nausea, headache and diarrhea
This spontaneous report was received from a medical assistant concerning an unspecified number of patient of unknown age and gender. The patients'  pertinent medical history, concurrent conditions, concomitant therapies, drug reaction or allergies were not reported. The reporter stated that, since 11-JAN-2016, the patients were vaccinated with doses of ROTATEQ, oral liquid, lot # L013203, expiration date 28-JAN-2017 (dose and dose number were unspecified), that were exposed to 47.9F during 5 minutes. No adverse experience has been reported. This is one of several cases received from the same reporter. Additional information has been requested.
Swollen lymph nodes in throat, swollen throat, joint pain in right arm, swollen arm (R), headaches, blurred vision from headache.
Patient inadvertently received a 3rd COVID vaccine dose.  Confirmed via MCIR, 2/04/21, 3/04/21 and 3/09/21.  Patient left one facility after the 2nd dose and received the 3rd dose on 3/9/21
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 3:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 43.30 years.  Concomitant medications were not provided.  On 30-Mar-2021, the vaccine with batch number 030B21A was moved to fridge. On 03-Apr-2021 20 vials were moved to the clinic and at 9 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 29-Apr-2021.   It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree Fahrenheit.  Treatment medications were not reported.  This case was linked to MOD-2022-566976 (Patient Link).
Fiebre alta 104F, Ronquera, cambio de comportamiento, debilidad, dolor de cabeza, latidos fuertes del corazón, respirar Dificultades al.
Initial report was received on 04 November 2011 from a health care professional. A female patient had received FLUZONE Intradermal, lot number UT4163AA (site and date of administration not reported) and an unspecified amount of time later, experienced extensive swelling at the injection site with redness, pain that shot down the patient's arm and a systemic reaction of nausea and chills. No further information was available at the time of the report. Outcome was not reported. Documents held by sender: none.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (patient's daughter) via medical information team and a Pfizer-sponsored program. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 (lot number: EN6207) as single dose (at the age of 54-years-old) for COVID-19 immunization. Medical history included blood pressure high. Concomitant medications included an unspecified blood pressure medication. The patient received her first Pfizer COVID vaccine on 17Mar2021. She tested positive for COVID on 30Mar2021. The reporter wanted to know if she should keep her appointment on 07Apr2021 to receive the second Pfizer COVID vaccine and if the patient was allowed to go out in public to get the vaccine since the patient was supposed to be quarantining for 10 days. The outcome of the events was unknown.
This was originally reported by a consumer concerning her 15 month old son who, on an unspecified date sometime after 7/21/00, was vaccinated with a 2nd dose of Hep-B vaccine recombinant (yeast) (lot 634778/1970J). In 10/01, the pt "started showing signs of autism" including not making eye contact, "several" unspecified developmental delays, "a lot of" repetitive behavior and a lack of speech. It was noted that the pt has been evaluated by a physician (details not provided). The pt's signs of autism persisted. Upon internal review, signs of autism was determined to be an "Other Important Medical Event". No further information is available.
REDNESS, SWELLING, HARD LUMP, ITCHING, ALL SYMPTOMS  PERSISTENT FOR MULTIPLE DAYS.
We have some patients who were given your vaccine after the published expiration date. These vaccines were administered on 3DEC2021, 6DEC2021, and 7DEC2021; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some patients who were given your vaccine after the published expiration date. These vaccines were administered on 3DEC2021, 6DEC2021, and 7DEC2021) 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 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some patients who were given your vaccine after the published expiration date. These vaccines were administered on 3DEC2021, 6DEC2021, and 7DEC2021). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (We have some patients who were given your vaccine after the published expiration date. These vaccines were administered on 3DEC2021, 6DEC2021, and 7DEC2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the vaccines were moved from the freezer to room temperature on the date of administration for all vaccines given.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-407154, MOD-2021-407155 (Patient Link).
It has been discovered that patient was given an expired dose of Moderna vaccine. The patient has not experienced an adverse event to the knowledge of clinical staff. Moderna has been contacted to assess viability of vaccine.
This case was reported by a consumer via call center representative and described the occurrence of itching both hands in a 89-year-old male patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, several days after receiving SHINGRIX, the patient experienced itching both hands. On an unknown date, the outcome of the itching both hands was not recovered/not resolved. It was unknown if the reporter considered the itching both hands to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left deltoid. The patient indicated that several days after receiving the SHINGRIX vaccine, he developed itching on the palms of both of his hands. This progressed to itching of both calves, predominately his left calf. The patient also had itching above his elbows, again predominantly was left elbow. The itching occurred every day. It would go away and return the next day. The reporter consented to follow up. This case has been linked to case US2019025968, reported by same reporter.
Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a 0.65 mL dose of Zostavax. Subsequently the patient experienced an outbreak of shingles. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. This is in follow-up to report(s) previously submitted on 4/13/2007.  Additional information from the physician indicated that no further information is available.
The patient consented to receiving PCV-13, but instead received HPV due to administration error.
Fever, chills, nausea, light sensitivity, sound sensitivity, headache, dizziness, cold sweats, dry mouth all  lasting over 36 hours.
PATIENT RECEIVED COVID-19 VACCINE ON  Dose 1 date: 12/22/2020,   Dose 2 date: 01/12/2021, AND TESTED POSITIVE TO COVID ON 8/31/21.
During the morning of 1-22-21around 10am, I started to get chills with muscle aches and headache.  Began to feel better by 9pm that day.  The next morning 1-23-21at 8am, I experienced flashing lights (precursor to migraine), followed by headache and fatigue the rest of the day.  Headache persisted throughout  Monday 1-24-21.
8PM had temp-sore arm-not feeling good; 10AM vomited-still has temp; recommended APAP, ice for arm, call MD if not better by tomorrow;
received her vaccine using aseptic technique and per best practices.  The Rph asked that she stay seated in the pharmacy area for 15 mins. 10 mins after receiving her vaccine, her friend alerted the pharmacy staff that was "not feeling well". She was pale, lightheaded and slight nauseous.
Pt recvd 3 doses of Hep B vax; 3rd dose was given 31AUG90; It was determined that pt was not immune to Hep B; Booster given 19OCT90;
Arm started swelling 3 inches down from the injection site with burning. Skin was red and feverish. Patient took acetaminophen to treat. Patient reports improvement of symptoms 5 days post vaccination.
Patient started to feel lightheaded and convulsed. He eventually slid down his chair and was caught by his parent. Our medical presiding Doctor tended to him and he felt better after some time with water and a snack bar. The ambulance came and he felt better at the moment and refused to go with them. Parents were with him and will be driving him to get his bloodwork done for further screening.
skin pain; painful chills; painful chills; She also had a rash back in late March; she went to a dermatologist, and they said it was a possible drug eruption; This spontaneous case was reported by a patient and describes the occurrence of PAIN OF SKIN (skin pain), PAIN (painful chills), CHILLS (painful chills), RASH (She also had a rash back in late March) and DRUG ERUPTION (she went to a dermatologist, and they said it was a possible drug eruption) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced RASH (She also had a rash back in late March) and DRUG ERUPTION (she went to a dermatologist, and they said it was a possible drug eruption). On 25-Mar-2023, the patient experienced PAIN OF SKIN (skin pain), PAIN (painful chills) and CHILLS (painful chills). At the time of the report, PAIN OF SKIN (skin pain), PAIN (painful chills) and CHILLS (painful chills) had not resolved and RASH (She also had a rash back in late March) and DRUG ERUPTION (she went to a dermatologist, and they said it was a possible drug eruption) had resolved.            Concomitant product included steroids.  It was reported that patient had skin pale and painful chills on 25-Apr-2023.  someone she spoke to had the same problem. Her last vaccine Oct-2022 and wondering if side effects would be active this year and if she was using a new medication. No one had any answers on what's causing the side effects. She was currently still experiencing skin pain and painful chills. She also had a rash back in late March and she went to a dermatologist, and they said it was a possible drug eruption. she used steroid cream, and the rash went away and used another cream on Apr-2023.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
I have been experiencing severe pain in my left arm, joint with limited range of motion beginning the day after receiving the Quad Flu vaccination on 9/19/2016.
Very slight nausea at around noon.  Fever of 103 at around 3:00-4:00 along with severe chills and muscle aches. Lasted for about 2-3 days.  This was the flu vaccine.
Expired Tenvac vaccine administered to patient/no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse (other health professional) via Medical Information (Reference number- 00422567) and transmitted to Sanofi on 08-Jan-2021.  This case involves a 34 year old male patient who received an expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] [lot U6101AA, expiry date: 23-Oct-2020] via an intramuscular route at an unknown administration site for prophylactic vaccination on 08-Jan-2021 (expired product administered). (latency: on the same day)   Medical history, medical treatments, vaccinations, list of concomitant medication and family history were not provided.  Patient received no other vaccines.   It was a case of actual medication error due to expired vaccine used (Latency-same day).  It was reported that, nurse did not have the site Event Information also wanted to know how to proceed further.    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.
Information has been received from a Registered Nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered a dose of GARDASIL on 24-DEC-2012 (lot number 672834/0131AE, expiration date 26-OCT-2014) (dose and route not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Pt recv vax on 11/23/98; within 24 hr post vax pt exp hot rx at vax site
4-5 days p/vax pt exp episode of staring, eye rolling back, lasting 30 sec & lethargy for 1/2 hrs; fever; crying for hrs;
This spontaneous report as received from a health care worker refers to a patient of unknown age. On 11-SEP-2013, the patient was vaccinated with a first dose of PNEUMOVAX 23 (lot # J005011, expiry date was 04-DEC-2014). Approximately on 11-SEP-2013, within a few hours, the patient experienced redness, swelling, warmth and pain at the injection site. Later approximately on an unknown date in September 2013, these symptoms got worsened and spread to the entire upper arm. Patient sought medical attention for the same (Office visit). The outcome of all the reported events was not recovered/not resolved. This is one of the 3 reports received from the Same Reporter Link (MARRS#1309USA005556 and 1309USA014074). Additional information has been requested.
2JUN soreness, swelling @ site of inj;3JUn PM temp 102 orally x 2 days;chills;
Experienced a cerebellar stroke, currently in hospital  recovering Pt felt, dizziness, nausea, vomiting.  Ambulance was called to get pt.  get MRI and CT Angiogram confirmed a stroke occurred.
On the ninth day following injection, a large (about 3/4 inch in diameter) red raised area appeared around the vaccine site.  It was not painful and no other adverse effects were noted.  This issue was gone in 48 hours.
I felt burning sensation at the injection site. Experienced tachycardia 200 lasted about an hour and 160 HR 200 lasted about 10 minutes.
Directly after the booster my arm felt sore, and then the day after I began to develop a bump on the vaccination site and it was warm  to the touch, protruding from my arm, and very hard. It took about 3 days to go away.   After the first dose, I began to have a bump form at the vaccination site  it was warm  to the touch, protruding from my arm and it went away after 8 days.  After the second dose,  I began to have a bump form at the vaccination site  it was warm  to the touch, protruding from my arm and it went away after 8 days.
Temperature excursions noted starting 1/20/.2023.  Revaccinating approximately 850 people following manufacturer guidelines.  No adverse events have been reported by any patients.  These excursions were self-reported.
fever,body aches tired. 100.9 first day 99.7 second day better after 48hours. took Advil
Patient broke out in a rash around the injection site and flu-like symptoms that lasted 3 days. She had severe pain in the arm that radiated into the neck.
Dermatographia And hives started about 12days later. Been taking Allegra which has offered mild relief.
Fever developed 24 hrs after injection. Fever and global headache without photophobia then occurred daily from 2/13/2020 through 2/27/2020.  Patient reported temp of 101 F (oral) each evening.
Flushing noted by pt -  face,arms, legs, No hives, Vital signs WNL, DX by doctor "dermatitis medicamentosus", Given Allegra 60 mgm po,Then this evening & BID if necessary.
pt admitted to hospital  with SOB, fever, and hypoxic; tested positive for COVID; pt's condition worsened and required intubation; comfort measures and extubation occurred; pt expired in the hospital; diagnosed with COVID pneumonia, septic shock, septic PE;
Face turned pale, anxiety, numb hands, didnt feel well, immediately after shot, pharmacist and manager came to calm patient down.  After 15 minutes patient felt fine and left.
Moderna COVID-19   Raised  itchy circular rash developed at injection site on 2/5/2021. Rash is about 2+ imches in diameter.
s/p DT c/o severe pain @ site on 1SEP93 described as toothache type pain; given Ibuprofen 1SEP93; no f/u since;
anaphylaxis  (within 10 min, sneezing, rhinorrhea, "throat closing", facial swelling, tachycardia, mucus emesis.  epi, benadryl, ED, solumedrol.  discharghed home from ED.  09/04/2007 2nd request sent to pcp. Hospital MR is in the works./pc 9/11/2007 Records received from PCP for OV 7/30/07 with no mention of AE, as well as hospital records for ER visit of same date. Child presented in ER with facial flushing, dyspnea, sneezing, facial edema, and vomiting shortly after receiving vax.  Treated with Epi and Benedryl at PCP office with resolution. Exam WNL. DX: Anaphylaxis. Allergic rxn to MMR.
Persistent redness at the site of injection for more than 5 days, warm to touch and a little pain.
golf ball sized knot on arm @ site of inject; skin @ site reddened; like a bruise; no fever; no signs of infection;
Mother called to report child has red welt - size of 50 cent piece over injection site with tenderness. Mother denies any other issues/concerns. Instructed to notify Dr. if S/S worsen. (Mother then stated child had upset stomach last night 10-18-16).
A 17 year old patient received the moderna COVID-19 vaccine.  No adverse reactions to report
KINRIX (Dtap-IPV) administered to 6 month old female. No adverse effect reported.
2 days after vaccine developed parasthesia, numbness of left upper extremity. Persisting and seen today 6 days after vaccine.
3:00- 2nd dose Pfizer covid-19 vaccine placed to left arm. 3:05- reports ?saw shooting stars? pt pale, laid him down immediately BP 122/82, HR 62, 100% on RA. 3:15 Pt reports facial numbness in lower face. Reports numbness to left arm. Pt report he feels cold. +Nausea. Brief neuro exam, equal facial symmetry, equal grips, Eye tracking normally, speech clear, normal and equal strength in all extremities. 145/80, HR 100 sat 100%. 3:28 Numbness to left arm resolved. Numbness to cheeks and lips continues. Nausea persisting. Pale. Pt reports he felt lower facial numbness 4 hours after first dose of Pfizer covid-19 vaccine, he did not seek medical care and reports the symptoms resolved. Pt in seated position, Pt given juice, tolerating well. BP 122/75, HR 104 98% on RA.  3:43 + emesis, HR 95-105, 98% on RA. PT states he feel better after episode of emesis. States lower facial numbness improving. PT pale.  PT states he feels well enough to leave. Pt encouraged to stay to be monitored. Pt reports that his daily food intake consisted of 1 breakfast Danish during the morning, did not eat during the day. Pt reports he smokes 1 pack of cigarettes per day.  3:50- Pt given small sips of water and crackers. Pt tolerating well. Pt no loner pale. Pt denies facial numbness, Vitals WNL. 3:59-Ambulation trial with PT and Nurse. Pt tolerating well. 4:15- Pt Alert and oriented. Pt expressed that he feels well and would like to leave. PT edu given to contact PCP. Pt advised to contact EMS or ER if symptoms return or if new symptoms arise. PT aware of risks. Pt escorted to Car by staff.
Case number PHEH214US006660 is an initial spontaneous report from the physician received on 02 Apr 2014. This report refers to a female of an unknown age. She was vaccinated with MENVEO (batch number: J008423) at a dose of 0.5 ml intramuscularly on an unknown date. On an unknown date, after vaccination her arm became swollen. The final outcome of the event was unknown. The seriousness and causality of the event was not reported.