chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time; gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time) and PRODUCT STORAGE ERROR (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2022 at 11:36 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time) and PRODUCT STORAGE ERROR (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time). On 22-Jan-2022, EXPIRED PRODUCT ADMINISTERED (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time) and PRODUCT STORAGE ERROR (gave booster dose from a vial that had been first punctured a little over 26 hours earlier & had been left at room temperature that entire time) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 13-Jan-2022 and was first punctured on  21-Jan-2022 at 9:21am and did not underwent temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 26 hours and give or take 20 minutes. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2022-459034, MOD-2022-466912 (Patient Link).
Patient became sweaty and pale after vaccination.  BP 137/90; HR 70; RR 16. Per pt, had not eaten since breakfast & vaccine given at 1248. Water, juice and crackers given. No distress noted. Sx resolved & color returned to face. Vitals stable, pt left in stable condition
Possible invalid dose: MD isn't sure if she had less than 0.5 ml admistered; This spontaneous case was reported by a health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Possible invalid dose: MD isn't sure if she had less than 0.5 ml admistered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Possible invalid dose: MD isn't sure if she had less than 0.5 ml admistered). On 11-Mar-2021, INCORRECT DOSE ADMINISTERED (Possible invalid dose: MD isn't sure if she had less than 0.5 ml admistered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable The physician was concerned that the patient might have received invalid dose. The reporter also stated that there was a possible invalid dose, however the reporter was not sure if the patient had less than 0.5 ml administered.   Concomitant medications were not provided.  Treatment information was not provided..   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: No new information was provided.
This spontaneous case, was initially received from other health professional on 10-Oct-2017, concerning a 51-year-old, adult, patient of an unspecified gender. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017, the patient was administered with FLUCELVAX quadrivalent (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration: intramuscular and anatomical location: deltoid). On the same day, the patient experienced redness, warm and itchy at the injection site. on 08-Oct-2017, the patient had recovered from the events (red, warm and itchy). The reporter assessed the events as non-serious. Follow up report received on 18-Oct-2017: The outcome of the event injection site itching was changed from not reported to recovered. The narrative was amended accordingly. Non-significant case correction received 10-Oct-2017: Batch number (195128) was captured in the case form and narrative was amended accordingly.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; INJECTION SITE PAIN; FATIGUE; VOMITING COULD NOT KEEP ANYTHING DOWN FOR 24 HOURS STRAIGHT; LOSS OF APPETITE; COULD NOT GET OUT OF THE BED; FEVER; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included cancer of unknown primary cause, rheumatoid arthritis, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage, the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine for drug used for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: Unknown) 1 total, dose was not reported, administered on 08-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included methotrexate and prednisone for rheumatoid arthritis.  On 08-APR-2021 (within 24 hours of getting the vaccine), the patient experienced vomiting (was not able to keep anything down for 24 hours straight), loss of appetite, fever, and injection site pain, and fatigue and could not get out of the bed. On 09-APR-2021, the patient started feeling injection site pain. The patient stated that she was not able to get out of the bed (could not get out of bed) from 8-APR-2021 to 11-APR-2021. The patient did not take any medications for any of the symptoms. On 20-MAY-2021, the patient was detected to have confirmed immunological vaccine failure (negative SARS-CoV-2 IgG antibody test). Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative Test result of 0.20 negative value no signs of antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On 11-APR-2021 the patient recovered from could not get out of the bed. On 12-APR-2021 the patient recovered from vomiting could not keep anything down for 24 hours straight, loss of appetite, and fever. On an unknown date the patient recovered from injection site pain. On 22-APR-2021 the patient recovered from fatigue. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210622018- Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient presented to clinic on 11-17-08 with complaint of left shoulder and arm pain.  States he received a flu shot 11-6-08 and pain began within a few hours of receiving flu shot.  States the pain did not go away and has worsened each day, now extends down lateral arm halfway to elbow.  Patient pointed to spot just below left acromium process and states this is where his pain is and states this is where injection was given.  No redness or needle mark was noted. Chart indicates vaccine given IM in the left deltoid. Evaluation is ongoing as to cause/nature of problem.
Red swollen, painful (L) upper arm at area of injection.  Mild erythema & cellulitis.  PREDNISONE/CEPHALOXIN.
Fever 101-102 on 4/19, no redness or swelling, "just arm killing him" LA
This is a spontaneous report obtained from a contactable physician. A patient of unspecified age, gender and ethnicity received, on an unknown date, PREVNAR 13 single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced peeling of the skin around the injection site. Clinical outcome of the event was unknown at time of this report.
70 year old lady with hx Crohns disease x 40 years, remote ileostomy, colon resection CKD, renal calculi, base creatine 2.4, GERD, HTN, HLD, COPD, had originally been admitted 1/1/22 for severe hyperkalemia, AKI, dehydration, was admitted to CCU, improved with treatment back to baseline nicely, had a gi workup and was positive for Giardia, was treated with flagly and discharged home on 1/9/21 and completed course of flagyl 2 days ago. However she is continuing to have loose stools filling up her ostomy bag, no bleeding but feels weak and nauseated at times, she is taking questran and probiotics. She presented to ED tonight for evaluation and now is again in AKI with BUN 109/Cr 8.2 and K 5.0,   Found to be COVID +
Pt recvd vax on 21APR92 & 23APR92 pt reported soreness, myalgia, fatigue & stiffness in neck & upper part of body on the side of the inject; seen in ER had paresthesias, disorientation & stiffness of lt shoulder & neck;
has continued to itch; Red area the size of an apple; Exhausted; Too sick to get up; Fever; Chills; Body pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Too sick to get up), PRURITUS (has continued to itch), PAIN IN EXTREMITY (Arm pain), ERYTHEMA (Red area the size of an apple) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), CHILLS (Chills), MYALGIA (Body pain) and PYREXIA (Fever). On 14-Mar-2021, the patient experienced ILLNESS (Too sick to get up), ERYTHEMA (Red area the size of an apple) and FATIGUE (Exhausted). On an unknown date, the patient experienced PRURITUS (has continued to itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (BABY ASPIRIN) at an unspecified dose and frequency. On 16-Feb-2021, PAIN IN EXTREMITY (Arm pain) had resolved. On 17-Feb-2021, CHILLS (Chills), MYALGIA (Body pain) and PYREXIA (Fever) had resolved. On 16-Mar-2021, ERYTHEMA (Red area the size of an apple) had resolved. On 17-Mar-2021, ILLNESS (Too sick to get up) and FATIGUE (Exhausted) had resolved. At the time of the report, PRURITUS (has continued to itch) had not resolved.            No concomitant medications were reported.   This case was linked.
Three (3) HPV, lot # (J013324) had been exposed to the out of range temperature and needed to be returned. These three vaccines were mistakenly and in administered to three (3) patients, whoever the staff person was who administered 3 doses of the HPV that should not been used, clicked on the new lot number (J012212) instead of the old lot # (J013324). We have been unable to identify the three patients who received the vaccines exposed to the out of range temp. I have been identify the 12 patients who administered HPV vaccine between the dates of 2/12 - 2/18/14 under lot number (J012212).
Soldier developed right shoulder pain, 1 day after receiving Anthrax vaccine in left tricep. Notably his symptoms began after completing a 6 mile foot march with a 70 lb back sack.
Per patient's daughter ,red spots on upper right arm appeared on  10/11/2020. Size of the spots were 1 to 2 inches and increased noticeable the next day as well as itching and discomfort. Patient was taken  to  Urgent Care ON the morning of 10/12/2020. She was given antibiotics, as treatment.  Daughters mentions an antibiotic injection given at the urgent care and Bactrim DS orally. She was diagnosed with Cellulitis. Treatment to be continue for seven days and follow appointment on 10/19/2020 .
Within 5 hours after vaccination, began seeing flashes of light in left eye, followed by clouded vision in left eye, leading up to and resulting in obscured field of vision in upper right quadrant of left eye, and periodic clouded vision throughout vision field of eye.
received both of his doses of the Pfizer COVID vaccine . Had a migraine after the first dose, and a mild headache after the second dose.  Unclear whether or not he suffered chronic migraines, although there was paperwork at the death scene stating that he had an appointment for a MRI on 3/1/21.  No recent influenza-like symptoms are reported.  He was found dead in his home on 2/22/21, seated at a chair at his desk.    Autopsy findings include an enlarged and dilated heart, granular kidneys, with the right kidney very shrunken and about half the size of the left kidney, and prostate hypertrophy.  There is no trauma.  The airway is not edematous.    Ancillary studies that are pending include microscopy, toxicology (basic testing plus vitreous chemistries), a COVID swab, a respiratory viral panel swab, HIV testing, and neuropathology.  The cause and manner of death on the death certificate will both be ?pending further studies? until these studies are completed.
Fatigue, body aches and bad headache wasn't able to get out of bed for two days. All symptoms resolved except for fatigue.
dose administered to patient was prepared from vial that was stored in freezer at -25 to -15 celsius for a total of 19 days which exceeds the allowed duration by pfizer of 14 days plus 3 days of temperature excursion.
As soon as I received my shot I immediatly  felt pain in my arm after we waited 15 minutes we were told we could leave.  I reported that my arm was hurting and was told to take tylenol when I got home. I could not sleep my are was throbbing.  The next morning in the shower I noticed the bruising and swelling. As bruises usually does it was spreading down my arm. I was beginning  to wonder if I should get the second dose so I made an appointment and went to the doctors.  I was told that when I got the shot it probably had hit a vessel. I did get the second shot and booster in my right arm with NO PROBLEMS!
unconsolable crying, t103, vomiting; sx began approx 5 hrs p/vax;
Pt with development of severe fatigue without alternative cause ~1 months after vaccination (cortisol, testosterone, TSH normal, OSA ruled out, no significant anemia)  He does not appear to have reactivation of his underlying sarcoidosis (PET scans without inflammation)
An expired Covid-19 pfizer vaccine was administered to the patient on 4/18/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Patient came to get revaccinated on 5-9 with another Pfizer 0.3ml dose.
my immune system went into overdrive and severe dry eye; my immune system went into overdrive and severe dry eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown, As with all the previous doses my immune system went into overdrive and severe dry eye.), for COVID-19 Immunization, reaction(s): "severe dry eye", "my immune system went into overdrive". The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), DRY EYE (non-serious), outcome "unknown" and all described as "my immune system went into overdrive and severe dry eye". The events "my immune system went into overdrive and severe dry eye" required physician office visit.  Additional information: It was reported that the patient was just administered the new vaccine last week. As with all the previous doses their immune system went into overdrive and severe dry eye. Patient had mentioned this to their eye doctor before and suspected it was a reaction to the vaccine.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Starting about weeks after the first vaccine Zaps in limbs and face. They were only happening occasionally. I also had red patches on arm at injection sight. Two weeks After the second vaccine I started feeling these zaps more often, they lasted for about 2 or 3 weeks through half the month of June. By mid June they had completely stopped. I saw neurologist 04/06/2021.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On 13-FEB-2019, the patient was vaccinated with PNEUMOVAX 23 via unspecified route (strength, dose, site of administration were not reported) lot # R018135, expiry date 15-JUN-2020, for prophylaxis. The suspected vaccine was stored in temperature above 47 degrees Fahrenheit (F) / (9 degrees Celsius) for 1 hour and 30 minutes. The highest temperature was 55 F. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Couldn't sleep; twisting stomach in knots; Feel like I gotta poop and gassy; Severe headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), ABDOMINAL DISCOMFORT (twisting stomach in knots), FLATULENCE (Feel like I gotta poop and gassy), HEADACHE (Severe headache) and NAUSEA (nausea) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022321A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, the patient experienced INSOMNIA (Couldn't sleep), ABDOMINAL DISCOMFORT (twisting stomach in knots), FLATULENCE (Feel like I gotta poop and gassy), HEADACHE (Severe headache) and NAUSEA (nausea). At the time of the report, INSOMNIA (Couldn't sleep), ABDOMINAL DISCOMFORT (twisting stomach in knots), FLATULENCE (Feel like I gotta poop and gassy), HEADACHE (Severe headache) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment was reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Non-significant Follow up appended on 16-MAY-2021,Initial receive date updated.
Blood pressure spikes ~200/100 for no apparent reason, typically before bed. Not correlated to medication, eating or stress. Had to visit ER in mid-Nov 2022 because I couldn't get it down without medical intervention.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 80-year-old male patient who received SHINGRIX. Previously administered products included acyclovir. On 27th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 8th May 2018, 11 days after receiving SHINGRIX, the patient experienced shingles and local swelling. On an unknown date, the outcome of the shingles and local swelling were not recovered/not resolved. It was unknown if the reporter considered the shingles and local swelling to be related to SHINGRIX. Additional details were reported as follows: The patient got an outbreak of bumps which he identified as an outbreak of shingles. The patient said that he had been struggling with shingles for the past 20 years and he constantly needed acyclovir treatment to combat his shingles. He said that this outbreak looked like any other outbreak that he had before. It did not look any different.
Shingles behind the  left arm and back of the body after booster; Mental confusion  after booster; In bed for 4 weeks  after booster; Unable to do anything after booster; Lost a lot of hair after booster; Horrible roaring in the ear; Runny nose that wont stop; Memory loss; Fatigue  after booster; Pain on the left shoulder and after booster; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles behind the  left arm and back of the body after booster), CONFUSIONAL STATE (Mental confusion  after booster), BEDRIDDEN (In bed for 4 weeks  after booster), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything after booster) and ALOPECIA (Lost a lot of hair after booster) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced HERPES ZOSTER (Shingles behind the  left arm and back of the body after booster), CONFUSIONAL STATE (Mental confusion  after booster), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything after booster), ALOPECIA (Lost a lot of hair after booster), TINNITUS (Horrible roaring in the ear), RHINORRHOEA (Runny nose that wont stop), AMNESIA (Memory loss), FATIGUE (Fatigue  after booster) and ARTHRALGIA (Pain on the left shoulder and after booster). 03-Nov-2021, the patient experienced BEDRIDDEN (In bed for 4 weeks  after booster). On 06-Dec-2021, HERPES ZOSTER (Shingles behind the  left arm and back of the body after booster), CONFUSIONAL STATE (Mental confusion  after booster), BEDRIDDEN (In bed for 4 weeks  after booster), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to do anything after booster), TINNITUS (Horrible roaring in the ear) and AMNESIA (Memory loss) had resolved. At the time of the report, ALOPECIA (Lost a lot of hair after booster), RHINORRHOEA (Runny nose that wont stop), FATIGUE (Fatigue  after booster) and ARTHRALGIA (Pain on the left shoulder and after booster) outcome was unknown.            No concomitant medications were reported   No treatment information was provided