chrisvoncsefalvay/vaers-outcomes huggingface dataset:
punctured product has been administered post excursion when the temperature has gone above 8 c total excursion lasted 20 minutes with no reported adverse event; Initial information was received on 21-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who reported that punctured product has been administered post excursion when the temperature has gone above 8 c total excursion lasted 20 minutes with no reported adverse event after receiving vaccine ipv (VERO) [IMOVAX POLIO].  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 unknown dose of suspect ipv (VERO) (Suspension for injection) (lot W1A191M, Expiry date : 16-Feb-2025) via unknown route in unknown administration site. On an unknown date he/she also received a unknown dose of the same vaccine (lot V1B902M, expiry date : 02-Jun-2025) (strength unknown) via unknown route in unknown administration site for Immunization and punctured product has been administered post excursion when the temperature has gone above 8 c total excursion lasted 20 minutes with no reported adverse event (poor quality product administered) (unknown latency) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event punctured product has been administered post excursion when the temperature has gone above 8 c total excursion lasted 20 minutes with no reported adverse 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.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was stored and administered beyond 30 days use by date) and PRODUCT STORAGE ERROR (Vaccine had been stored in fridge for over 30 days prior to administration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. The vial was initially stored in the refrigerator on 27 May 2022. The vial did not undergo any temperature excursions. Manufacturer expiration date was reported as 10-Sep-2022. Body site of vaccination was reported as deltoid. Treatment medication was not provided by the reporter. This case was linked to MODERNATX, INC.-MOD-2022-600655 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-600655:Master case.
Initial report was received from a healthcare professional on 17 October 2012. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose intradermal FLUZONE Intradermal (batch number and site of administration were not reported) on an unspecified date. On an unspecified date, after vaccination, the patient experienced redness from shoulder to elbow. The corrective treatments and laboratory investigations were not reported. The patient's outcome was not reported. Documents held by sender: None.
Abscess left axilla on 4/19/02. Incision and drainage on 4/25/02. Regiment of Dicloxacillin 250 qid X 7 days.
Brain Itch Brain Fog Exhaustion Anxiety Depression Pain Extreme Pain Walking Issues Falling Leg moving to left when going straight
RECURRENT ANAPHYLACTIC SHOCK; IDIOPATHIC INTRACRANIAL HYPERTENSION; This spontaneous report received via company representative from a patient concerned a patient of unspecified age and sex. The patients 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, batch number: 042A21A, expiry: UNKNOWN)dose was not reported, 1 total administered on 06-Apr-2021;11:54 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 at 12:10pm the patient was reacting to the vaccine and was hospitalized and received treatment for extreme Anaphylactic Shock ( had 3 bounceback reactions over the course of the next 24 hours. Patient was treated with Epinephrine (iv drip), Steroids and multiple Nebulizer treatments. Patient was in the ICU for 3days and a regular room for e additional days. Hospitalized from 6Apr through 11Apr.I was home for several days and was again hospitalized 19Apr through 22Apr for a severe headache, ringing in ears, numbness in left arm, leg, an leg. Also for blurry/double vision in right eye. On 19-APR-2021, the patient was again hospitalized for a severe headache, ringing in ears, numbness in left arm, and leg, blurry/double vision in right eye. It was determined to be Idiopathic Intracranial Hypertension and still being treated for it and will be attending Occupational and Physical therapy to get vision, arm and leg to work properly again. Patient was hospitalized for 3 days. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient had not recovered from idiopathic intracranial hypertension, and the outcome of recurrent anaphylactic shock was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210452704-Covid-19 vaccine ad26.cov2.s-Idiopathic intracranial hypertension. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210452704-Covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).
Bell's Palsy; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (Patient husband) reported for a patient (Reporter wife).  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The reporter (husband) reported that on 30May2021, the patient (his wife) was affected by Bell's Palsy. This was exactly after 2 weeks after her 2nd Pfizer COVID shot. He wrote to you previously as well, but he didn't receive any reply from your side. Yesterday we contacted the Neurologist and he suggested him to write to you again informing about the situation. It seems to be an acute Bell's Palsy and he request you to take this matter on an urgent basis. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100953034 Same reporter/ drug/ event for different patients
pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in my arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included FUROSEMIDE, CARVEDILOL, PRAVASTATIN, FENOFIBRATE, ASPIRIN [ACETYLSALICYLIC ACID], METFORMIN, EMPAGLIFLOZIN (JARDIANCE), DULAGLUTIDE (TRULICITY), LOSARTAN, DIAZEPAM and ZOLPIDEM for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in my arm). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ice. Neither Tylenol nor ice helped.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for 10th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Post general anesthesia, very  frequent urination. Loss of taste and smell . I ate post 3 hours from my procedure. noticed the food and drink, had no taste or smell to me.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Was informed to sit after the vaccine. Waited  a few minutes, then sat over by the clinic. Technician informed pharmacy staff that he fainted. Staff offered him water after he regained composure. Patient stated he had a previous history of adverse events from vaccines. Will eat and drink more fluids before coming back for second vaccine.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 10-JAN-2014, the patient was vaccinated with a dose of improperly stored PEDVAXHIB (lot number reported as J005672, Expiry date: 05-DEC-2015) (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vertigo, Headache, lymphadenopathy, fever, nausea, vomiting, fever, chills
Broke out in a rash for about 2 weeks; Dr said I was allergic to the preservative in the shot; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced rash and reaction to vaccine preservatives. On an unknown date, the outcome of the rash and reaction to vaccine preservatives were recovered/resolved.   It was unknown if the reporter considered the rash and reaction to vaccine preservatives to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The patient received Shingles vaccine and broke out in a rash for about two weeks. The patient's family doctor said that the patient was allergic to the preservative in the shot.
May 29th, 2021 woke up with rash on torso and forearms.  Rash spread to entire body except face, shins, and genitals within 2 days.  Rash was not raised or itchy and some areas coalesced into splotches.  Red dots formed on roof of mouth and the back of the throat was all red, nasal passages closed, elevated blood pressure.  June 1st, 2021 Urgent Care said "likely vasculitis" injected Benadryl and IV solution and prescribed Prednisone. Currently on steroid taper.
This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. There was  no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 22-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported). This is one of several reports received from the same source. Additional information is not expected as no further information is available.
Shooting pain into right or left hand; body aches (everywhere, especially back of neck); migraine;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 09-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
lump the size of a big black olive inside the inner thigh of her right leg near her genital area.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Mar-2021 and was forwarded to Moderna on 06-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MASS (lump the size of a big black olive inside the inner thigh of her right leg near her genital area.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced MASS (lump the size of a big black olive inside the inner thigh of her right leg near her genital area.). At the time of the report, MASS (lump the size of a big black olive inside the inner thigh of her right leg near her genital area.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   Reporter did not allow further contact
Patient's left leg swollen and painful. Patient's mom states there is a little bump where injection was given. It was red for 3-4 days. No fever, no pain and no fussiness. Hepatitis A vaccine mistakenly given for HIB. Patient will come in for HIB.
Hypertension, severe neck pain and headache for 5 days requiring emergency care.  Have continued neck pain and loss of mobility of neck muscles requiring multiple physician visits and subsequent physical therapy, cortisone injections and now receiving botox injections every 3 months to manage pain and mobility.
Found a lump in my left breast. Went to doctor and found it was cancer. I was in remission for 15 years before that date.
Sudden onset of nausea and vertigo. Worst with bodily movement or bending. Continuing at time of this report. Reviewed forum posting. Apparently this is being reported by others.
shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (battling for years). Previously administered products included Zostavax.   On 1st February 2019, the patient received the 1st dose of Shingrix. On 11th February 2019, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Ten days later after receiving Shingrix, the patient developed a flare up of his teeth and sinus cavities. The patient believed that it was a Shingrix outbreak. The patient was a dual transplant patient and has been battling shingles for years. The reporter gave consent to follow up. For tolerance to 2nd dose of Shingrix, refer case US2019AMR115698.
Sore arm that patient claimed to be immobile the next day after receiving 2 shots. Shoulder was swollen.
This spontaneous report has been received from a nurse pre scriber referring to a 23 year old patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. Approximately on and unspecified date in 2014 (reported as 3 and 1/2 years ago), the patient was vaccinated with the first dose of GARDASIL 9 or with GARDASIL (strength, dose, route, lot# and expiration date were not reported) for prophylaxis, as the reporter stated that it was unknown which vaccine was given to the patient. Furthermore, it was reported, that approximately on an unknown date in 2016 (reported as about 1 and 1/2 years ago), the patient received a second dose of GARDASIL 9 or with GARDASIL (also unknown which vaccine was given). No adverse events were reported.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 17th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain, fever and chills. On an unknown date, the outcome of the injection site pain, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient stated that she received SHINGRIX in the left arm on the day before reporting date and she developed intense pain at the injection site. The patient was also experiencing fever and chills. The reporter gave consent to follow up.
PATIENT STATES THAT AFTER HER 2ND DOSE OF PFIZER COVID VACCINE STARTING ON 9/10/21 SHE STARTED TO EXPERIENCE MORE NOTICEABLE HAIRLOSS. SHE SAID HER SCALP IS ITCHY AND HER HAIR HAS BEEN SHEDDING MOST NOTICEABLY WHEN SHE TAKES A SHOWER. SHE SHED A LARGE AMOUNT OF HAIR ON 9/19/21 AND SHOWED US DOCUMENTED PICTURES.
Swollen Lymph Node; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Dec2021 14:45 (Lot number: FD0809) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Mar2021, when the patient was 51 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: El3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 14:45, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 02Dec2021, outcome "recovering", described as "Swollen Lymph Node". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
About 12 hours after vaccination, I fell very ill with headache, fever, and nausea. As time went on, my hands started to go numb along with my legs and face. My muscles began to seize violently and I collapsed to the ground. I was later revived by co-workers and EMS who came shortly after. Following this event, I started to experience pain in and around my heart the next morning. The next day, I went to urgent care where some tests were run and I was able to see a doctor. They sent me home saying 'all was normal'. However, the pain persisted and I made an appointment with the cardiologist. There, I explained my symptoms and the cardiologist looked at my EKG where they found something abnormal. It also became obvious that the urgent care had missed some things as well as not ordered/done all the necessary tests. I left the cardiologists with a diagnosis of Acute Pericarditis. I am currently receiving treatment for it.
left subscapular lymphnode swelling with tenderness; left subscapular lymphnode swelling with tenderness; This is a spontaneous report from a contactable nurse. A 45-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration from 16Dec2020 11:15 to 16Dec2020 11:15 at a single dose for covid-19 immunization. Medical history included seasonal allergy and Sulfa drugs Allergies. Concomitant medication included minerals nos, vitamins nos (CENTRUM A to Z) and naproxen sodium (ALEVE). The patient had left subscapular lymph node swelling with tenderness on 01Jan2021. The outcome of the events was recovering.
Pt given a Pfizer booster at the age of 15 by RN, against CDC recommendations of 16 and older. No adverse reactions observed or reported during observation period.