chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received dose from a vial punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received dose from a vial punctured more than 20 times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received dose from a vial punctured more than 20 times). On 19-Nov-2021, PRODUCT ADMINISTRATION ERROR (Received dose from a 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 reported. No treatment information provided.   This case was linked to MOD-2021-393508 (Patient Link).
Immediately after first dose experienced unusual menstrual symptoms. Two days after second dose experienced severe menorrhagia. Bled for 4 hours straight first day with larger and more clots than I have ever experienced before. Have been bleeding since, and am now experiencing chest pains and lightheadedness - I'm guessing from how much blood I've lost. I started saving the clots I could salvage in a pint-sized container and put them in the freezer. The container is almost full. I believe I've lost over two pints of blood over the past four days. This has never, ever, ever happened to me.  I know that menorrhagia is one of the side effects of Pfizer's vaccines. This was not an informed decision that I was able to make. If I end up having to go to the hospital, Pfizer should pay for this.
Bilateral hand swelling and joint pain lasting 4 days, extremely enlarged axillary lymph nodes 5days post vaccine
This spontaneous report as received from a vaccine coordinator refers to multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L042258, expiration date 18-AUG-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 28.4 degrees Fahrenheit for 2 days, 21 hours, 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
localized erythema & edema, tenderness lt upper arm just below inj site;poss early cellulitis vs rxn to pneumo vax;tx w/cefzil x 9 days & warm compress;
upon receiving shot pt exp immed & severe pain; pt was instructed to put ice on site then heat in AM; could not lie on arm or touch it for 2 weeks;
received dose from vial punctured more than 12 hours before; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 26-NOV-2021. The vial was initially punctured on 26-Nov-2021. The vial had no temperature excursions. Patient did not have any adverse reactions.   This case was linked to MOD-2021-400110 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow-up received contains Significant information-Updated Patient demographics-Height, Weight, Race, Ethnicity. Updated Product information-Patient route of administration, Anatomical location.  Contains Updated Reporter's comment-Patient did not have any adverse reactions.
50 % loss of movement in the right side of his body (arm and leg); lost the physical ability in the right arm and the right leg; can't walk without assistance; lost fifty percent movement on right side in his arm and leg. It is not hurting. It is weak; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269), via an unspecified route of administration on 07Feb2021 08:30 at a single dose on left arm for COVID-19 immunization. Medical history included high blood pressure, enlarged prostate, and COPD (chronic obstructive pulmonary disease). Ongoing concomitant medications included lisinopril, and tamsulosin hydrochloride (TAMSULOSIN). The patent was taking unspecified concomitant medications. The patient previously received flu shot months ago for immunization. The patient did not receive any vaccine 4 weeks prior to COVID vaccine. The patient was administered Pfizer COVID19 vaccination on this past Sunday, 07Feb2021. He was feeling alright on Sunday. On Monday (08Feb2021) when he woke up, he had lost fifty percent movement on right side in his arm and leg. It is not hurting. It is weak. He had lost the physical ability in the right arm and the right leg. The shot was given in left arm. He said he still has it and he can't walk without assistance. The events did not require a visit to the emergency room or to the physician office. He is scheduled to get the next shot on 04Mar2021 at 3:30PM. The patient has not recovered from the events.
My arm swelled from shoulder to elbow, it was very red and on fire and itchy.  For 3 days I took Advil, Benadryl, iced my arm and used Cortisone Cream  It finally began to calm done on Sunda,y 2-7-21
5-6 days after receiving first Moderna covid vaccine pt. began not feeling well. On 02/10/2021 she saw a provider in an office for eval of abdominal pain and diarrhea and sent home. On 02/15/2021 she presented to a local ED with continuing symptoms, transferred to Medical Center. She is currently an inpatient there with a diagnosis of multiple blood clots in abdomen and brain and antiphospholipid syndrome.
Dizziness, Headache, NauseaVomiting, difficulty standing straight  Narrative:  Other Relevant History:
Patient was at Health Department to receive 2 month old vaccines along with 4 year old brother who was receiving kindergarten vaccines. Nurse inadvertently gave 4 year old brother's vaccines (MMRV and Quadracel) to patient. Error was realized and mom was notified, Patient also received Rotateq, Hep B, Prevnar 13 and Hib to stay up to date on vaccinations. Mom was notified that patient may have rash at injection site or high fever secondary to MMRV given. Nurse will follow up with mom next week. No adverse reaction noted at this time.
Pt recv vax in 11/98; during the vax pt exp flushing sensation down arm, the next day pt exp soreness at vax site x 3 wk
This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (has not gotten second dose yet) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced product dose omission issue (has not gotten second dose yet). At the time of the report, product dose omission issue (has not gotten second dose yet) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No relevant concomitant medications or treatment information reported.
Information has been received from a nurse practitioner concerning a female patient who was vaccinated with a first dose of Gardasil. After receiving the vaccine, the patient had a seizure for 5 minutes. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Pt came into the HCF locally to request his Moderna Booster.  He did not have his card.  He provided a state driver's license.    Staff member A assisted him with application completion.  Staff member B looked up information on the computer to make out vaccination card.   His first vaccine 6/2/21, second vaccine was 10/29/21.  Card was  given to the client.  He took his form to the vaccination table and was given third shot booster.  During check out by staff member D, it was determined that his second vaccine was in October. Staff member C informed me that the booster was given too early. I advised the client to notify his primary care physician.    I notified My Manager and Director, I called client at 3:30 and he stated he was doing well.  No signs of any reaction.
Temp 99.5 this AM. Treated with Tylenol several days after immunization. Right leg swollen with knot and returned. Mother stated was larger this AM and it has gone down some now. Right upper thigh hot red area 3cm by 5cm and knot 3 cm by 1.5 cm other was okay now.
INJECTION SITE REACTION RED RAISED SKIN APPROX 3 TO 4 INCHES ROUND.
patient was given expired vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a physician.  This case involves a 21-years-old male patient who received fourth dose of the suspect RABIES (HDC) VACCINE [IMOVAX RABIES] vial  (frequency: once, strength: standard, lot number: P1E52 and expiry date: 30-Oct-2020 via an intramuscular route in the right shoulder) (expired product administered) on 07-Dec-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  No other vaccines were received.  It was an actual medication error case due to expired product administered (latency: same day).  Reporter asks about asks what is appropriate follow-up after expired vaccine given. Reporter stated that product was not used for the first time and safety test was not successful.  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.
left arm swollen; right arm swollen; right arm itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swollen), VACCINATION SITE SWELLING (right arm swollen) and VACCINATION SITE PRURITUS (right arm itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Breast conserving surgery (She had breast surgery on left side) and Lymph node excision (removed lymph nodes).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen), VACCINATION SITE SWELLING (right arm swollen) and VACCINATION SITE PRURITUS (right arm itchy). At the time of the report, PERIPHERAL SWELLING (left arm swollen), VACCINATION SITE SWELLING (right arm swollen) and VACCINATION SITE PRURITUS (right arm itchy) outcome was unknown.            No concomitant medication details were reported.  No treatment medication details were reported.   This case was linked to MOD-2021-056299, MOD-2021-056299 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: No new information was provided.
This is a spontaneous report from a contactable consumer. This 77 years old female consumer received PREVENAR 13 on 19Mar2015, intramuscular, in left arm, at 0.5 ml single. Concomitant medications included KLOR-CON tablet once a day ongoing, atorvastatin tablet once a day for high blood pressure, aspirin small dose once a day ongoing, atenolol (Zydus Pharmacy) at 25 mg once a day for high blood pressure (she has been taking it for years) ongoing, vitamin D at 1000 mg, 1x/day ongoing, LEVOTHYROX 75mg, 0.5 tablet daily Monday through Saturday and 1 whole tablet on Sunday for low thyroid ongoing, chlorthalidone (manufacturer Mylan) 0.5 pill by mouth every other day and unspecified senior citizen vitamin once daily ongoing, and fish oil. Medical history included ongoing blood pressure high, fell and hurt left elbow (that bled for a week because of the blood thinner she took), 2 foot surgeries (she has titanium in both feet), hysterectomy, ongoing low thyroid and terrible headaches all her life until she took atenolol and she did not have them anymore. The patient stated that when she took a whole pill of chlorthalidone, it made her dizzy, so they decreased the dosage; this happened over 4 years ago; Doctor was aware of symptoms. On 19Mar2015 the vaccinated arm was mildly sore. On 26Mar2015, 8 days later she noticed a big, red 3.5 inch circle mark slightly painful and slightly swollen, but not tremendously painful. Both of these events involved admission to hospital. The patient was supposed to go back to doctor to get a different Pneumonia shot and was wondering if she should get it after experiencing the above symptoms. Doctor was not aware of her symptoms. The patient was recovered from the events at the time of report. Follow-up (27Mar2015): New information from a contactable consumer included vaccination date and onset date corrected to 19Mar2015, concomitant product fish oil. Follow-up (13Apr2015): Additional information received from the contactable consumer includes therapy duration of concomitant drugs and outcome. Case upgraded to serious due to hospitalization. Follow-up attempts are completed. No further information is expected.
The patient states that an unknown amount of time after his Smallpox vaccination he developed blisters on his hands. Had allergy tests done and it revealed an sensitivity to Chlorine. Patient still thinks its is Smallpox related.
administered dose past 12-hour mark; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past 12-hour mark) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past 12-hour mark). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past 12-hour mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications, Lab data details and Treatment information were not provided.   This case was linked to MOD-2021-363303, MOD-2021-365214, MOD-2021-365212, MOD-2021-364190, MOD-2021-365032, MOD-2021-365214 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Non- significant follow-up appended:  e-mail ID added.
Getting a polo shot didn't prevent me from getting the disease; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer (Patient).  This case involved adult patient who reported that getting a "polo shot" didn't prevent him/her from getting the disease (Influenza), while patient received INFLUENZA VACCINE.   The patient's medical history, medical treatment(s), 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 at unknown administration site for prophylactic vaccination.  On an unknown date, the patient reported that getting a polo shot didn't prevent him/her from getting the disease (Influenza), unknown latency following the administration of INFLUENZA VACCINE.  No relevant laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on the batch number for this case.
blood and mucous in stool 1 day after vaccine administered and lasted about 2 weeks
one dose of ADACEL was given post excursion with no reported adverse event; excursion lasted for 15 minutes and the maximum temperature of the refrigerator reached 8.8 degrees Celsius; Initial information received on 12-Apr-2022 regarding an unsolicited valid non-serious case received from healthcare professional.  This case involves an unknown demographic patient to whom one dose of adacel was given post excursion with no reported adverse event and excursion lasted for 15 minutes and the maximum temperature of the refrigerator reached 8.8 degrees celsius while receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (lot U6807BA and expiry 21-Sep-2022) (strength, dosage, formulation, route, administration site: unknown) for immunization.  On an unknown date the patient reported with one dose of adacel was given post excursion with no reported adverse event (product use issue) and excursion lasted for 15 minutes and the maximum temperature of the refrigerator reached 8.8 degrees celsius (product temperature excursion issue) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.  It was reported that caller does not have any patient information available at this time.  Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine was discontinued on an unknown date.  It was not reported if the patient received a corrective measurement for both the events.  At time of reporting, the outcome was Unknown for both the events.   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.
First Moderna vaccine on 17Jan2021, then the second one on 24Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine on 17Jan2021, then the second one on 24Mar2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M208 and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine on 17Jan2021, then the second one on 24Mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Moderna vaccine on 17Jan2021, then the second one on 24Mar2021) outcome was unknown.            Concomitant medication was not provided. Treatment medication was not provided.   This case was linked to MOD-2022-486653 (Patient Link).
I had a scratchy sore throat and stuffy nose. I tested positive for COVID-19 at the clinic. The doctor prescribed me PAXLOVID. I started feeling better the next day other than being sleepy.
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2016, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) lot # L046506 with expiry date on 17-MAY-2017, (strength, dose, route and anatomical location were not reported). No product quality complaint was involved and no adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
left leg lost movement and feeling and then both legs; left leg lost movement and feeling and then both legs; falling down; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Abalone" (unspecified if ongoing); "Known allergies: Sulpha drugs" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, Lot unknown=False, Administration date=Feb2021, Administration time=04:00 AM, Vaccine location=Left arm), administration date: Feb2021, when the patient was 76 years old, for COVID-19 IMMUNIZATION, reaction(s): "Falling down", "Left leg lost movement and feeling and then both legs", "Left leg lost movement and feeling and then both legs". The following information was reported: FALL (medically significant) with onset 2021, outcome "unknown", described as "falling down"; MOBILITY DECREASED (disability), SENSORY LOSS (disability) all with onset 2021, outcome "not recovered" and all described as "left leg lost movement and feeling and then both legs". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jun2021) Negative. Therapeutic measures were taken as a result of mobility decreased, sensory loss, fall.  Additional information: No other vaccine in four weeks and no other medications in two weeks. No COVID prior vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257251 same patient/drug/event, different doses;
Patient received immunization 9-9-10. Patient reported to pharmacy on 9-29-10 that she has continued to feel pain (and a "pulling" sensation) at the injection site. Patient did not have pain when she presented to pharmacy.