chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022 at 2:41 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 2:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.   It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  The vial(s) moved from freezer to refrigerator on 07-Sep-2022.   It was reported that the vaccines had undergone several temperature excursions in Aug 2022.   Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the local authority was made aware of the situation. No adverse reactions were reported for any of the patients at the time of the report.  No treatment information was provided.
patient received dose of expired IPOL/no AE; Initial information was received on 10-Nov-2021 regarding an unsolicited valid non-serious case received from a Physician and health care professional via [Medical Information (MI) - 00852064].  This case involves a 12 year-old male patient who received dose of expired vaccine IPV (VERO) [IPOL] (expired product administered).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On 10-Nov-2021, the patient received 0.5 mL dose of suspect IPV (VERO) (Suspension for injection, lot R1F972M and expiration date: 03-Oct-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was reported "Caller/Practice Site Manager reports that patient received dose of expired IPOL on 10Nov2021; they did not catch the expiration date when product was administered; safety report will be completed. Caller would like to know if dose needs to be repeated since expiration date of 03Oct2021 was fairly close to administration date".  It was a case of an actual medication error due to expired vaccine used (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   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.
When the child was laying down for the night she complained of pain in her arm. I noted a small welt at the injection site. By the next morning, her small welt was 2 in x 4 in, swollen and hot to the touch. She also complained of it itching and burning. It was very tender to the touch. It's been nearly 36 hours since vaccination and her arm is looking worse by the minute.
"I recieved the Moderna COVID 19 Vaccine on Monday 12/29 at 1530. During the night body aches, slight sore throat and significant injection site soreness. Yesterday, I felt extreme tiredness, slight body aches and increased pain in the injection site. Today, 12/30, symptoms are much better. Soreness in the injection site is still present."
This spontaneous report was received from a 60 year old female patient regarding herself. On 24-FEB-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On 24-FEB-2014, the patient experienced headache the same day after she received ZOSTAVAX. No treatment was given. No medical attention was sought. The outcome of headache was reported as not recovered. Did Adverse event appear after reintroduction was reported as not reintroduced. The relatedness of the event to ZOSTAVAX was unknown. Additional information has been requested.
Patient report soreness at the injection site and there is soreness and a lump under her arm (armpit area).
An hour and a half after injection pt reports she had itching all over her body, Redness and extreme swelling of the arm.
The morning following vaccination, patient stated her right ankle was swollen.  Over the next few days the rest of her right foot swelled, which is the current state.  She described it as "pulling" feeling when asked to describe how it felt.  (It looked slightly swollen compared to her left foot).  Recommended she see her doctor, which she agreed to.
This spontaneous report as received from a registered nurse refers to a 6 months (recently 9 months) patient of unknown gender. On 06-SEP-2013 the patient was vaccinated with the first dose of ROTATEQ (lot# unspecified) (dose and strength unspecified). On 14-JAN-2015 the patient was vaccinated with the second dose of ROTATEQ (lot# unspecified) (dose and strength unspecified). On 08-APR-2014 the patient was vaccinated with the third dose of ROTATEQ (lot# unspecified) (dose and strength unspecified). No adverse symptoms reported. Additional information has been requested.
Swelling; Reddness darkened; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8455) via an unspecified route of administration in the arm left on 06Apr2021 at 16:45(at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ascorbic acid, boswellia serrata resin, chondroitin sulfate, collagen, glucosamine hydrochloride, hyaluronic acid, manganese sulfate, methylsulfonylmethane, sodium, sodium borate (OSTEO BI-FLEX), ascorbic acid, tocopheryl acetate, glutathione, riboflavin, acetylcysteine, betacarotene, copper, zinc, selenium, bioflavonoids nos (ACCUVIT)  and omeprazole (PRILOSEC); all from unknown date for unknown indication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6955) via an unspecified route of administration in the arm left on 16Mar2021 at 16:15 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 06:00 the patient experienced Swelling subsided somewhat after 12-18 hours. Redness darkened and still continues 36 hours later. The was reported that she experienced Similar reaction 35 years ago to an unknown, airborne chemical that circulated through the ventilation system in a building where she was working. Dermatologist at the time, recommended taking Benadryl. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken for the events and included treatment herself with Benadryl. The clinical outcome of the event swelling and redness darkened was recovering.  No follow-up attempts are needed. No further information is expected.
This case was reported by a nurse practitioner and described a 42 year old female pt who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On unspecified dates, the pt received two immunization series (six doses) of Engerix-B.  The nurse practitioner reported that the pt was informed after each series that "...they did not have any titer/protection."
Patient received first dose of Moderna's COVID-19 vaccine at  Park on 4/10/2021. Vaccine administered 1044. In the observation lot, patient complained of lightheadedness and dizziness. She was assessed by Dr.  and  PA-C. Initial BP was 60's/40's. Patient was given one dose of epinephrine IM and patient was transported via EMS to the ED.
Vaccine given after 48 hours of a punctured vial; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine given after 48 hours of a punctured vial) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine given after 48 hours of a punctured vial). On 09-Apr-2021, PRODUCT STORAGE ERROR (Vaccine given after 48 hours of a punctured vial) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD21-076647, MOD21-076566, MOD21-076653, US-MODERNATX, INC.-MOD-2021-078047, US-MODERNATX, INC.-MOD-2021-078057 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: NNI; Sender's Comments:  MOD21-076647: MOD21-076566: MOD21-076653: US-MODERNATX, INC.-MOD-2021-078057: US-MODERNATX, INC.-MOD-2021-078047:
Pfizer vaccine given on 2/11/21, 3/9/21  CHIEF COMPLAINT Bladder/urinary incontinence, generalized weakness, back pain   HISTORY OF PRESENT ILLNESS Pt is a 81 y.o. male who is admitted for bladder/urinary incontinence, generalized weakness and back pain, brought to an outside emergency department with family.  PMH includes peripheral neuropathy, obesity, CKD, HTN, hyperlipidemia, remote history of polio, known spondylolisthesis of lumbar spine, Covid-vaccine x 2.  Initially presented on 11/10, history gathered through chart review and with patient.  Upon admission patient was hemodynamically stable, febrile to 38.5, and requiring 2 L nasal cannula for saturations in the 90s.  Blood work was re
General body pain; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General body pain), FATIGUE (Fatigue) and PYREXIA (Fever) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced PAIN (General body pain), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, PAIN (General body pain) was resolving and FATIGUE (Fatigue) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On unknown dates, the patient experienced fever and fatigue after vaccination and general pain. On an unknown date, fever and fatigue after vaccination resolved. Moderna vaccine was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (expiry date: August 2014, dose, units, route of administration, anatomical location, lot number were not reported). No adverse effects were reported. Additional information has been requested.
patient received vaccine on 7/23/20.  On 7/29/20, patient called the pharmacy and said she has a red rash around the injection site and slight discomfort at injection site, she has full range of motion with arm. Patient believes rash began on or around 7/29 but not on days immediately following vaccination.   Advised patient to take ibuprofen and watch rash for any spreading.
Four hours after immunization, noted pain around injection site with arm motion. Pain lasted approx 30 hours and completely resolved. 48 hours after immunization, noted pain in right inner knee/thigh area and quad muscle when climbing or descending stairs. Leg pain lasted 36 hours and has completely resolved.
Patient received a second Pfizer shot, and within 5 minutes of receiving it, experienced seizure that lasted for 10 minutes.  EMS was called and was transported to the hospital.  The hospital is familiar with this patient because she has other underlying conditions that makes her at high risk for being admitted to the hospital.
Patient says that on 5/13 her entire body (on both sides) broke out in large welps. They were also very itchy.  She used benadryl tablets and topical hydrocortisone.  I saw her on 5/16 and she still had a rash present but she says this was much improved.
101.7-101.9 fever for two full days after second dose. Extreme body aches. Chest pain/tightness to the point I couldn?t sleep or lay down. Headache
3cm area of swelling, erythema, warmth and pain to palpation developed at site of immunization one day after administration
Diffuse itching (developed within an hour of getting vaccine). Diffuse hives developed within 24 hours.
Patient received 1st dose of SARS-COV-2  Moderna from somewhere else.  Patient received 2nd dose of SARS-COV-2 Pfizer from a local Community Health Clinic.  The Vax record now shows 1st dose was Moderna which contradicts with 2nd dose of Pfizer. No adverse reactions have been noted as of 11/10/22 when it was discovered.
This spontaneous report as received from a Licensed Practical Nurse and Office Manager refers to a female patient of unknown age. Medical history and concomitant medications were not reported. On 08-APR-2013 the patient was vaccinated with ZOSTAVAX lot # J000433, expiration date 11-APR-2014 (dose, and route were not reported). On an unknown date in 2013, after vaccination, the patient experienced reaction on the injection site (deltoid area), which was red, with swelling and heat. The patient was diagnosed with cellulitis and was treated with KEFLEX. The outcome of events was reported as recovered/resolved. The relatedness between events and ZOSTAVAX was not reported. The Licensed Practical Nurse stated that pharmacy had ZOSTAVAX vaccine with the Lot number J000444. This is one of several reports from the same source. Additional information has been requested.
faint, sweating, chest tightness, dryness in mouth, swollen tongue, SOB, large rash on arm, swollen arm elevated temp in arm, numbness, tingling & nerve problems, severe pain in lt arm, shoulder & fingers;
Information has been received from a health professional concerning a 5 year old female, who on 29 OCT 1996 was vaccinated with one dose of varicella virus vaccine live (site unknown) (lot # unknown). Subsequently, it was reported that in May 2001, the patient was diagnosed with a mild case of chicken pox. Unspecified medical attention was sought. It was reported that in the Spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the patient had an exposure to these cases. The reporter also indicated that the vaccine was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently the patient recovered. No further information is available.
Sensitivity to loud noises or certain pitches, causing balance difficulty. Sensitivity occurred both the day after receiving my booster as well as on 11/25/21 (more than one week later).
p/ pt recv vax the pt failed to seroconvert. MD felt that the pt exp was not related to therapy w/vax
Information has been received from a female patient of unknown age referring to herself. Concurent condition and medical history were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (strength, dose, route, lot# and expiration date were unknown) injection in the buttocks (Drug administered at inappropriate site). No adverse event was reported. Additional information is not expected because the reporter details were not provided.
varivax 1 administered left thigh SQ on 04/23/2005. Immediate redness, hives at site. Benadryl PO administered and  recheck of site 30 minutes later shows reaciton resolved.
Attending Physician: DO     Date of Admission: 2/15/2022     Source of Information: available medical record   History of Present Illness: The patient is a 71y.o. male who presents with shortness of breath, leg swelling and vomiting.  He complains of worsening dyspnea on exertion over the past several days.  He suspects he may have had Covid recently although his home test was negative.  He has been fully vaccinated against COVID-19, including booster.
Patient came in to pharmacy approximately 28 hours post vaccination, with a very swollen right arm, the arm was also red and warm to the touch. The swelling started around injection site and continued down the arm until halfway between the elbow & wrist. Patient could not fully extend arm at the swollen elbow. Patient stated her arm began to hurt & swell about 4 hours post vaccination. She did not contact upon her arrival at the pharmacy & contacted PCP exchange and pt. was told to proceed to ER. Pt was treated with steroids, antibiotic and pain medication. MD suspected allergic reaction or possible infection. Has only received 1 dose thus far & little to no improvement.
in about 30 minutes after shot, hives began. They continue for 3 days - stopped now
Severe neck pain radiating into skull causing migraine, constant since day after vaccine. Has not responded to any OTC remedies. Also has not responded to chiropractic care.
The vaccine was injected on 11/29/21 and higher than it should have been, into my shoulder area. The following day 11/30/21 I had slight numbness in my entire left arm.  Loss of range of motion and significant pain in my shoulder and pain down my arm to above my elbow area, at rest and with any type of movement. Per ER physician, X-ray was unremarkable. The pain started to subside on 12/5/21, however on 12/7/21 the pain returned significantly along with a low grade fever. On 12/10/21 the significant pain in shoulder and down my arm continues, along with low grade fever, and a general feeling of illness in my head. I self tested for Covid, results are negative.  An ultrasound was performed on 12/10/21, per physician, also unremarkable.
On Tuesday August 26,2008 we had a 18 year-old female patient who came in with mother for vaccines, that were in need promptly requested by school. Patient information, vaccine questioner, and VFC application were given to the patient due to the fact that it was the patients first time at the facility. After the patient had concluded inputting here information she was registered in LINK. Patient at the moment was due for a total of 4 vaccines which are as follows: VARICELLA, HPV, MENINGOCOCCAL, and HEPATITIS A. The patients mother was then informed that the subsequent vaccines mentioned were due along with IIPV, but that GARDASIL was not needed by school system. After the mom was informed about GARDASIL and what it prevents, mother agreed to render that vaccine along with the other three. The patient was then taken to the triage room and vitaled. The temperature recorded at the time was 97.9 oral-temperature. Routing slip from LINK was then given to PAC to approve all vaccines that were in need. After PAC approval all four vaccines were administered. Patient was advised by medical assistant to have a seat in the waiting room, while vaccine card was being printed. While the patient was seated at the waiting area she collapsed while being seated. The patient was unconscious and ammonia was passed by nasal area. The patient gained conscience, but immediately went unconscious again. While patient collapsed again she urinated at the same time. Ammonia was passed for the second time and gained conscience permanently. Oxygen tank was then put on the patient to help the oxygen flow. Paramedics were called and arrived 5 minutes latter at the scene. Paramedics vitaled the patient and recommended for her to go with them. Patient was adamant and denied the advice and she signed the AMA for the paramedics. The patient left 5 minutes after the paramedics were gone. Patients was called the following day of the incident and mother stated daughter was fine and no problems were noticeable.
ELECTRIC SHOCK SENSATIONS; This spontaneous report received from a patient concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular) The batch number was not reported and has been requested dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced electric shock sensations. The action taken with covid-19 vaccine  was not applicable. The outcome of electric shock sensations was not reported. This report was non-serious. This case, from the same reporter is linked to 20210438273.
Breakthrough case admission after three vaccines Moderna 3/3/21 Lot# 029A21A;  Moderna 3/31/21 Lot3 028a21a;  mODERNA 10/25/21 lOT# 039d21a
I am not fully sure, but I believe the vaccine was a cause in developing subepithelial infiltrates of my right eye. My theory is that it triggered an auto immune response.
Customer received flu shot in right arm. Immediately upon injection a burning sensation was felt. Arm hurt from injection site to elbow until afternoon of 9/30/10. Now elbow area is sore and there is a bump.