chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vial punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial punctured more than 20 times) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial punctured more than 20 times). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial punctured more than 20 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.
AFTER GETTING OUT OF THE VACCINATION ROOM THE PATIENT WENT TO BUY SOME CLOTHES AND FALL. SHE INDICATED SHE IS DIABETIC AND AT 3PM SHE HAVEN'T GET ANY BREAKFAST OR LUNCH. SHE GOT DIZZY AND FALL IN THE STORE.
Bilateral pulmonary embolisms  Admitted to hospital, kept on heparin IV drip, given morphine and Alprazolam, respiratory and physical therapy until breathing stabilized, prescribed blood thinners(Eliquis)  , released with scheduled visits
I had a severe allergic reaction; rash over her body; It's red, it burns, itches, & it's welting up; red, it burns, itches, & it's welting up; red, it burns, itches, & it's welting up; red, it burns, itches, & it's welting up; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (I had a severe allergic reaction), RASH (rash over her body), RASH ERYTHEMATOUS (It's red, it burns, itches, & it's welting up), BURNING SENSATION (red, it burns, itches, & it's welting up) and RASH PRURITIC (red, it burns, itches, & it's welting up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced RASH (rash over her body), RASH ERYTHEMATOUS (It's red, it burns, itches, & it's welting up), BURNING SENSATION (red, it burns, itches, & it's welting up), RASH PRURITIC (red, it burns, itches, & it's welting up) and URTICARIA (red, it burns, itches, & it's welting up). On an unknown date, the patient experienced HYPERSENSITIVITY (I had a severe allergic reaction). At the time of the report, HYPERSENSITIVITY (I had a severe allergic reaction), RASH (rash over her body), RASH ERYTHEMATOUS (It's red, it burns, itches, & it's welting up), BURNING SENSATION (red, it burns, itches, & it's welting up), RASH PRURITIC (red, it burns, itches, & it's welting up) and URTICARIA (red, it burns, itches, & it's welting up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.
This is a spontaneous report from a non-contactable consumer (patient). This 33-year-old male patient received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME; lot number unknown) via an unspecified route of administration in the left arm on an unspecified date (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the 4 weeks prior to vaccination. The patient previously received the first dose of COVID-19 vaccine (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported experiencing extreme flu symptoms, unable to sleep, body aches, fever and nausea on unspecified dates. The clinical outcomes of extreme flu symptoms, unable to sleep, body aches, fever and nausea were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Received shot at 8:45pm felt okay, got home and within the hour felt nauseated, dizzy, quivering, instant headache and fever, severe pain in arm, legs felt like they were on fire, feet were ice cold.
Child presented to the ER in status epilepticus and had bloodwork CT and IV ATIVAN that stopped seizures and then child was transferred to hospital where EEG and MRI were done and neuro consult was done and child was discharged the next day.
Fever and aches  Two days after the vaccine I had swollen lymph nodes under my arm and near my breast. They were painful and large . It lasted for 3-4 days
Chills, Fever, (my normal temp is 97.4-97.8 daily for the past year) and after the shot, my temp rose to 99, 100, 101.2 - from Sat., 3/6 - Sun., 3/7. I was exhausted and slept most of the night and day on Sun., 3/7. I then woke up thinking the worst was behind me - I ended up getting stomach pains and had diarrhea late Sun., 3/7 and into Mon., 3/8 followed by a throbbing headache and feeling super tired. The headache lasted through Thursday afternoon and is gone now. I am still pretty tired.
Syncope episode.O2: 96%, HR: 50, B/P: 118/50, respirations unlabored and WNL.Treated and assessed and RNs onsite.911 called and assessed by Fire Dept, recommended Pt be transferred to ED. Pt refused transport to ED, and left with his family.
Severe pain and swelling of arm.  Unable to eat, stand up, had intense headache, ringing in ears and had some itching.  I was lethargic and slept most of 3 days.  Extremely exhausted for entire week.  Still recovering and tired even today 3/9.   I had to take my rescue inhaler and then took benydrl every  4 hours for a week.
Case number PHEH2014US025370, is an initial spontaneous report received from a medical assistant on 16 Dec 2014. This report refers to a 62 years old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701, expiry date: Mar 2015), at a dose of 0.5 ml intramuscularly in the left deltoid on 23 Oct 2014, that was stored at minus 0.6 degrees Celsius for 2 hours and 50 minutes. No adverse event was reported following this maladministration error (incorrect storage of drug).
No adverse event to vaccine but developed covid and need to be hospitalized, unsure if GI symptoms were related to covid? 5/4 11am- spoke to patient states on 4/21 developed vomiting abdominal pain and diarrhea and was seen in ED. Was going to be admitted and have endoscopy and PCR came back positive. ID saw her in hospital and could not say whether her symptoms were caused by covid. was sent home and has to wait to have endoscopy. states still having GI symptoms and during night spiked 101 temp and has been taking tylenol. The following day saw primary diagnosed with UTI
joint motion limitation; joints swollen; joints hot; joints very painful/severe arthralgia; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jun2022 at 18:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "lichen sclerosis et atrophicus" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "atrophic vaginitis" (unspecified if ongoing); "penacillin" (unspecified if ongoing); "scallops" (unspecified if ongoing); "dairy" (unspecified if ongoing). Concomitant medication(s) included: COMBIPATCH; CLOBETASOL topical; METRONIDAZOLE topical; VIT D [VITAMIN D NOS]; CALCIUM; PATANOL. Past drug history included: Codiene, reaction(s): "known allergies: codiene". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunisation; Bnt162b2 (DOSE 3, SINGLE; Lot number: FD0809; Anatomical location: Left arm.), for Covid-19 Immunisation. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "joint motion limitation"; JOINT WARMTH (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "joints hot"; JOINT SWELLING (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "joints swollen"; ARTHRALGIA (non-serious) with onset 16Jun2022 at 03:00, outcome "unknown", described as "joints very painful/severe arthralgia". The events "joint motion limitation", "joints swollen", "joints hot" and "joints very painful/severe arthralgia" required physician office visit. Therapeutic measures were not taken as a result of joint range of motion decreased, joint swelling, joint warmth, arthralgia.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200886854 Same patient and drug, different event;
panic attack after receiving vaccine - diaphoresis, anxiety. He lied down, drank water and recovered in 30 minutes. He declined referral for medical/counseling services. Was given resources for counseling and will self-refer.
02/14/2022 Vaccination Within 24 hours, fever, nausea and HA. The HA lasted until April. I was able to have an in-patient appt.  They said that it was intramuscular nerve pain and they administered a cortisone injection. The injection shot took care of it immediately. I did have the same experience 1st vaccination, not with the booster.
Patient was 17 at the time and was administered Moderna which is approved for 18 and older
UTI; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), MYALGIA (Body aches) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). On 01-Apr-2021, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI), MYALGIA (Body aches) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received included event outcome
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included rituximab (RITUXAN). Subsequently, the patient may have possibly experienced decrease in rituximab (RITUXAN) levels after vaccination. The pharmacist could not provide any further information and was not reporting an adverse experience. The patient sought unspecified medical attention. No product quality complaint was involved. No further information is available.
4-29: grandmother noticed red swollen area on right leg (area of DTaP inj). 4-30: brought to clinic, has large 3"x4" "splotchy" type rash on right upper leg in the area of the DTaP injection. Not warm to the touch, not swollen. Grandmother says it is better today after taking benadryl. Taking him to Dr.
Heart Palpitations; last about 5-15 minutes; occurs approximately 3-4x/ week
27 y.o. male w/reaction to smallpox vax. Bumps to left armpit, right great toe and chest and face. Abdomen, nasal fold erythematous pustules noted. Genome vaccinia. Med: Benadryl hydrocortisone ? cream.
High fevers; Swelling and pain under his left armpit.; Swelling and pain under his left armpit.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient reported for himself). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, on an unspecified date as dose as dose 1, single for COVID-19 immunisation. Caller states that patient received his 2nd dose of the Pfizer COVID-19 vaccination on Tuesday morning. The day after he experienced on unknown date high fevers that have since resolved. His concern today is after receiving the vaccine in his left arm, he now has swelling and pain under his left armpit. Caller would like to know how long to expect the side effects to last. The outcome of the event pyrexia was reported as recovered on unknown date and while other events was unknown.  Information on lot/ batch number has been requested.
As of 6/28 I still have a raised circle area around the vaccine site. It is also very tender.
Took unrefrigerated doses of Vivotif; Spontaneous report received on 10FEB2020.  A pharmacist reported that a consumer "took unrefrigerated doses of Vivotif" (PT: Product storage error) while being on Vivotif for immunisation. On 02FEB2020, the consumer took the first dose of Vivotif which was refrigerated. The consumer took the remaining three doses of Vivotif which were unrefrigerated. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took three doses of Vivotif which were unrefrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took three doses of Vivotif which were unrefrigerated (product storage error). Vivotif must be stored in the refrigerator at the recommended temperature. Considering the nature of the event, the causality of product storage error is assessed as not applicable to Vivotif.
Upon returning the vaccine to another store we reallized that it is only good 30 days from the deep freeze.  We thought  that it was good until 10-30-2022 according to the mfg website when kept at room temperature.  We received this medication on  06-02-2022.  We called the manufactor and gave them the information.  They are going to do batch testing to see if we need to revaccinate.
Numbing sensation in left arm; weird feeling in the left arm, arm feeling heavy, the arm having a weighty feeling and the feeling might be moving down to the forearm, the feeling for a while was down to the  elbow; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient).  This case involves a 52 years old female patient who experienced numbing sensation in left arm (hypoaesthesia) and weird feeling in the left arm, arm feeling heavy, the arm having a weighty feeling and the feeling might be moving down to the forearm, the feeling for a while was down to the  elbow (limb discomfort), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past vaccination(s) included INFLUENZA VACCIN with patient gets flu shot yearly with no issues.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) in right arm for immunisation.  On 12-Sep-2020, the patient received a 0.5 mL once dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2001 and expiry date 17-May-2021) via intramuscular route in the left arm for prophylactic vaccination.  On 12-Sep-2020, the patient developed a non-serious numbing sensation in left arm (hypoaesthesia) and weird feeling in the left arm, arm feeling heavy, the arm having a weighty feeling and the feeling might be moving down to the forearm, the feeling for a while was down to the  elbow (limb discomfort) on same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Case details: Reporter stated that after vaccination with Flublok she experienced the adverse events and stated that the left arm was where she had the Flublok that the feeling was not uncomfortable and that there were no physical signs that can be seen or felt on the arm and that the feeling has not changed in severity but has just extended down the arm more and the feeling began the day of the injection. She stated that she gets this flu shot yearly with no issues.   Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  The patient was not recovered from the events.
After receiving vaccine the child turned pale and almost passed out. Nurse carefully brought her to the floor and child attended to by EMS.  Mother stated child has pass out before after a shot.
Her sister is also diabetic.; nausea; vomiting; diarrhea; dizziness; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 08Sep2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, vomiting, diarrhoea and dizziness on an unspecified date. She was also diabetic on an unspecified date. She would like to know if these are known side effects of the first dose of the vaccine and how long they may last. The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
I did not have an adverse reaction to the vaccine. I went in for a mammogram 11/21/2022 and they found a mass in my left breast. I had a biopsy, and it was determined to be a malignant tumor. I had lumpectomy on 12/27/2022. I have no family history of breast cancer.
the consumer on receiving the liquid DTap-IPV portion and not the Hib  of PENTACEL/no AE; Initial information received on 17-Dec-2021 regarding an unsolicited valid non-serious case received from a pharmacist via call center via Agency (Reference number- 00903124).  This case involves a 2-month-old (unknown gender) patient who received the liquid DTAP-IPV portion and not the HiB portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Product preparation issue).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (latency: same day).  It was reported "A Pharmacist also wanting to know if the patient could possibly get another dose of PENTACEL or does Sanofi make a stand alone Hib vaccine."  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 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.  There will be no information available on the batch number for this case.
This is in follow-up report(s) previously submitted on 5/14/2004. Information has been received from a RN concerning a first grade male pt who on 12/18/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed chickenpox. Unspecified medical attention was sought. A product quality complaiant was not involved. Follow-up information was received from the registered nurse who indicated that the patient was vaccinated at an unknown location, and nto at her facility. Chickenpox was diagnosed on or about 17-Jan-2004. No further information is expected. It was noted that pt's from the same source had a similar experience. (WAES # 0403USA02088, 0403USA02109, 0403USA02110, 0403USA02112, 0403USA02113, 0403USA02114, 0403USA02115).
Missed 2nd dose; Ears were warm to the touch; Ears were very itchy; Severe allergic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction), EAR DISCOMFORT (Ears were warm to the touch), EAR PRURITUS (Ears were very itchy) and OFF LABEL USE (Missed 2nd dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0030210) for COVID-19 vaccination.     No medical history was reported.     On 03-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 5:00 PM, the patient experienced EAR DISCOMFORT (Ears were warm to the touch) and EAR PRURITUS (Ears were very itchy). In March 2021, the patient experienced HYPERSENSITIVITY (Severe allergic reaction). On 31-Mar-2021, the patient experienced OFF LABEL USE (Missed 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) for Ear pruritus, at a dose of 2 dosage form. In March 2021, EAR DISCOMFORT (Ears were warm to the touch) and EAR PRURITUS (Ears were very itchy) had resolved. On 31-Mar-2021, OFF LABEL USE (Missed 2nd dose) had resolved. At the time of the report, HYPERSENSITIVITY (Severe allergic reaction) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       No concomitant medications were provided.  The patient's husband reported that the patient was getting second shot on 18-May-2021.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-MAY-2021 contains significant information: Added reporter address and patient's date of birth. New event "Missed 2nd dose" was added. On 18-May-2021: Follow-up information received on 18-MAY-2021 contains significant information: The outcome of the events changed from Unknown to resolved.
Patient returned day after vaccine with erythema at site of vaccine and also with urticaria on arms, legs, chest and neck. Patient had previous flu vaccine with no reaction.
Pt recv vax on 1/12/99; on 1/25/99 pt exp chills, aching neck & back, felt feverish; 1/27/99 pt exp maculopapular bumps on scalp, axilla, waist & groin w/ itch which dried & scabbed
DYSPNEA, POSTURAL DYSPNEA, HEART PALPITATIONS, SOB.  ALBUTEROL HFA USED AND DID NOT RESOLVE SYMPTOMS.  TRIPOD POSITION WAS ONLY SLIGHTLY HELPFUL.  LEFT STERNAL BORDER PAIN -- NO RESOLUTION.
Within 15 min of receiving the H1N1 vaccine the pt had SOB, & a skin eruption on the surface of the R arm, (the vaccine was given in the L arm). The next day her tongue had anesthesias, which still exist, but, now the anesthesias are more toward the back of her tongue instead of the tip. She also started getting stabbing pain in her neck, both shoulders, L buttock, and also paresthesias in her feet. These have resolved. She has a loss of appetite.