chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 2nd dose administered on 11-MAR-2021 and Dose 3 administered on 24-JUN-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 11-MAR-2021 and Dose 3 administered on 24-JUN-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis). Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis, APREMILAST (OTEZLA) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 11-MAR-2021 and Dose 3 administered on 24-JUN-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 11-MAR-2021 and Dose 3 administered on 24-JUN-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was reported.   This case was linked to MOD-2022-623920 (Patient Link).
Initial misuse report received from a healthcare professional on 21 March 2013. A new born patient was administered a dose of ADACEL. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Erythema with induration at MMR injection site; itching, followed by periorbital tingling and hives on right leg and right face at ear. Benadryl 50 mg PO 12:15 PM. Epinephrine 1:1000 lm/IM 1:00 PM, medial dose. Symptoms responded, reduced within 1 hour.
Patient got rash on her extremities, on her back, stomach area. It was red and itchy. Patient went to dermatologist and got meds.
L deltoid red, swollen and tender, no fever, no discharge, eating and sleeping well.
Expired Tenivac administered, with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 23 years old female patient who got expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Oct-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection lot number (expiration date- 24-Sep-2023) not reported via unknown route in unknown administration site (dose, strength: not provided) for Immunisation (expired product administered) (latency- same day).Information on the batch number was requested.  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 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.
SHORTNESS OF BREATH; HEADACHE; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight, height, and medical history were not reported.   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 18-APR-2021, the subject experienced shortness of breath. On 18-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and headache. This report was non-serious.
Initial report was received from a health care professional on 14 June 2012. This is a cluster of two patients who received DAPTACEL and IPOL and developed cellulitis. The other patient was captured in case number 2012-06187. A four-year-old female patient had received the following vaccinations on 12 June 2012: a dose five intramuscular injection in the left thigh of DAPTACEL, sanofi pasteur Ltd., lot number C3944AA, a dose four intramuscular injection in the right thigh of IPOL, sanofi pasteur SA, lot number H1305, an injection of MMR II, Merck (lot number, route and site not reported) and an injection of VARIVAX, Merck (lot number, route and site not reported). On 13 June 2012, the patient experienced a site reaction on the left thigh of redness and swelling. The doctor diagnosed the patient with cellulitis and prescribed "cefeloxin" 250mg/5ml. Illness at the time of vaccination and past medical history were reported as none. The patient's outcome was unknown. Documents held by sender: None.
pt lt shoulder started aching;told MD office;then pain in lt hand/thumb; orthopaedic MD Dx rotator cuff problems in shoulder & Preiser's disease in hand(Preiser's is the avascular necrosis of  scaphoid bone;very rare about 30 cases a year). Annual FU states upper arm at site of injection still very painful and does not have full range of mobility in that arm.
couldn't breath; This is spontaneous report from a contactable consumer reported for himself. A 59-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Leg Left on 28Mar2021 04:00 (Batch/Lot Number: tr8734) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced couldn't breath (life threatening) on 28Mar2021 08:00. Outcome of event was unknown.   Follow-up requested for more information.
Trouble breathing/shortness of breathe trying to treat with inhaler but no help. Ongoing since first injection.  Second injection has been when it became worse.
Fever deve @ 2AM on 14JUL892 14 hrs p/inject; fever spiked to 104? R; pt was fussy; temp present x 48 hrs;
Client states that she yelled when flu shot administered.  "It hurt more than usual."  Was immediately sore and progessively became more sore overtime.  Presently client cannot pick up anything with affected arm.  Client called Family doctor who feels Flu shot was administered too high and hit a nerve.  She will be seeing her MD today.
Inflammation, pain, hardening and hot the area and after a week the redness returns to the heat in the area and hardening with a little itching after it had been removed.
Pt received pfizer bivalent 5-11 year old forumulation after the BUD of 12/28/2022.  No adverse event reported by patient's mother.
Evening of the vaccine: mild left arm pain at injection site. Day 1 post vaccine: mild left arm pain all day,  By 3pm back pain, flank pain , skin over thighs and right arm tender to the touch. 10pm-5:30am uncontrolled rigors and chills with fever up to 100.5.  Day 2 post vaccine: moderate left arm pain, moderate muscle aching, moderate fatigue, occasional nausea, some joint pain, had to leave work after 1/2 day. The evening begins with nausea, then diarrhea all night until  Day 3 post vaccine: severe left arm pain, now arm is swollen over injection site for 1st time, sob with activities (1 flight of stairs) and pain when taking a deep breath.  Diarrhea resolved by mid day. Muscle and joint pain is better today. severe fatigue, left work after 1/2 day.  Day 4 post Vaccine: severe left arm pain, swollen over injection site, fatigue is moderate. muscle pain resolved, DOE and pain on deep breaths improving, muscle and joint pain resolved  Day 5 post vaccine: moderate left arm pain, swelling improved. fatigue continues, DOE and pain on deep breaths improving Day 6 post vaccine:left arm pain resolved,  fatigue continues to improve slowly, was able to work a full day, DOE and pain on deep breaths is mild. Day 7 post vaccine: DOE and pain on deep breaths has resolved, fatigue is mild and improving Day 14 post vaccine: fatigue has resolved and I was able to resume aerobic exercise.
Body aches, fever, chills, light headed sore throat swollen lymph nodes in both axillas.
Post menopausal bleeding approximately 18days after injection.  I have not had a period for over a year and a half until after the Covid vaccine.  bleeding has been for at least 9 days so far.
Onset of high fever, irritable beginning 2nd day after vaccine Temp up to 104 at home per mom. 102.1 at office 1/10, 102.3 1/12 at office use of TYLENOL/MOTRIN - initial exam1/10 child was fussy but her exam was fairly unremarkable - 48 hr later there was Tonsillitis but rest of exam normal - on 1/12/09 given AMOXICILLIN for tonsillitis.
Accidently give Proquad and Varivax at the same time. The patient had no adverse effects.
GI problems; Hair falling out; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (GI problems) and ALOPECIA (Hair falling out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A, 013A21A and 037F21A) for COVID-19 vaccination.     The patient's past medical history included Heavy smoker. Previously administered products included for Smoker: Chantix (Batch/lot number: 00022175 Expiry Date: Sep2022 Dosage previously discontinued/treatment completed. During the Chantix, she was chewing Nicorette to help.) until May 2020, Chantix (Taking 1 tablet and twice a day and then started taking one tablet in the morning and half of a tablet at night.) until May 2020; for Heavy smoker: Nicorette (Lot: 0HV1799, Expiry date: Apr2022 4mg, Lot: BA856 and Expiry date: Oct2023). Past adverse reactions to the above products included Hypertensive with Chantix; No adverse effect with Nicorette; and Sleep difficult with Chantix.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (GI problems) and ALOPECIA (Hair falling out). At the time of the report, ABDOMINAL DISCOMFORT (GI problems) had not resolved and ALOPECIA (Hair falling out) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
A report was received from a healthcare professional on 11/19/03 concerning a 53 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to the touch one day after receiving Fluvirin on 11/18/03. On 11/19/03 the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Minor discomfort on injection Site; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Minor discomfort on injection Site) and MYALGIA (muscle aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (Minor discomfort on injection Site) and MYALGIA (muscle aches). On 01-Feb-2021, VACCINATION SITE DISCOMFORT (Minor discomfort on injection Site) and MYALGIA (muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Muscle twitches/spasms and variable degree of weakness in various locations throughout body including but not limited to toes, calves, shins, thighs, upper and lower back, neck, arms, and occasionally face.  No activities relieve or worsen symptoms.  No patterns; variable occurence in different regions and may happen in multiple regions simultaneously.
I developed atypical chest pain 3 days after the shot. Chest pain that was sharp as intermittent and has been on going since 9/8/21.
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vaccine was administered to total of 24 patients including 15 males and 9 females and were mostly for booster shots. No side effects was reported No concomitant medications were reported. No treatment information was provided.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-JAN-2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 19-JUL-2013, the patient was treated in the center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The patient was prescribed Acyclovir, Medrol and Gabapentin for management of her painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
local reaction to left arm at injection site (erythema, swelling, pain) with significant painful left sided axillary lymphadenopathy
22 year old male has experienced burning at the injection site and soreness in the affected arm with each anthrax vaccine.  Both of these symptoms have worsened with each successive dose.  Immediately after the 3rd dose he was observed by immunization personnel for 15  20 minutes because he looked pale. He denies any chest pain, difficulty swallowing or breathing at that time.  He does not recall any significant reaction to the 4th dose, other than the burning and arm pain mentioned above.  At some point after the 3rd or 4th dose, he began to experience bilateral knee pain that had not completely resolved before receipt of the 5th dose.  He reports a worsening of the knee pain since the 5th dose that is rated as 5/10 at its worst and is intermittent.  Approximately two hours after the 5th dose he began to ache all over and had sudden onset of fatigue.  He went home and went to bed.  The next morning he reported for drill even though he was not feeling well.  He felt so bad that he was unable to drive himself home.  He reports a fever of 102.0, chills, "couldn't breathe", and "everything felt far away".   He was given fluids at the NG unit and released to his father.  On the way home, he had his father stop the car and call 911.  He was transported to the Emergency Room via EMS.  In the ER, he states he received "a shot", and fluids with a diagnosis of dehydration.  He slept for the next two days.  He did not regain his previous energy level for 8 days post vaccination and reports having fever for 2  3 days post vaccination.  He saw a physician at the clinic a few days later, but no tests were run or examination performed.
Patient states that he had pain in his rotator cuff area and thinks that the vaccination was given too high in the arm.
I received my vaccine yesterday. I waited at the location for 15 minutes with no issues. After about 20 minutes, I developed a burning sensation at the injection site.  Approximately 30 minutes following the vaccine, I began experiencing an intense itching and hives of my opposite forearm. Then shortly after, my shins and front of ankles started itching. I began getting little bumps with an itch to several other areas of my body, also including redness and itchiness of one side of my face. At about 40 minutes, I also experienced a cold sensation felt at the injection site, almost like what it feels like after removing an ice cube from the skin.           The itching of my skin on several areas of my body persisted for about an hour and a half. The welts and itchiness almost completely subsided at about the 2 hour mark. I did take two benedryls once I got home which was about an hour and a half after the injection.  Today, the following day after injection, the bumps and itchiness are still no longer present. I have been experiencing a very sore arm at injection site and extreme exhaustion today though.
pt recv vax & 2wk p/vax exp a sudden onset of bilat arm weakness & dysesthesia;pt recovered 4 days later w/no sequelae;2mo later pt exp sx;pt to MD;CSF & MRI report of cervical spinal cord were nl;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. On 18-NOV-2021, the patient got Covid (suspected clinical vaccination failure and suspected covid-19 infection) with minimal symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the  suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number:90000205003. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0: 20211203745-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
(L) arm intermittent numbness/tingling down arm from shoulder, when (L) arm stretched behind back-sharp pain occurs and he drops any item in hand. Pt. states started after receiving pneumo 23 and MENACTRA vaccine.
At 13:55 on 3/19/21 patient received 1st Pfizer vaccine to left arm. At 14:05 on 3/19/21 patient developed itching to bilateral lower and upper arms. Denies shortness of breath, denies trouble breathing, denies chest pain, denies hives.
pt was here for well child, pt in need of booster vaccines, pt was given vaccine questionnaire and completed the only yes was FLUMIST from last year. Dr examined pt and advised vaccinations. Upon doing the vaccines, after doing the last vaccine the patient passed out, she slid sideways on the table but did not hit floor. Patient did not lose LOC, Dr was advised she examined the pt., pt was monitored for 1 hour in the office, patient sent home with no side effects.
Started later in the evening after shots and lasted two whole days. Right leg was red, swollen, tight, warm to the touch, had fever, not himself.