chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients were administered the Moderna vaccine that was supposed to be discarded; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna vaccine that was supposed to be discarded) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna vaccine that was supposed to be discarded). On 01-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patients were administered the Moderna vaccine that was supposed to be discarded) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow Up information received on 28 Jul 2021, contains No New Information.
Ringing, buzzing in ears. My husband had the shot the same day & had same effects.
Death NOS; Was never the same/ complained of vaccine/ picked up off ground/had head hitting repeatedly; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and head discomfort. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the head discomfort was unknown. The reported cause of death was unknown cause of death.   The reporter considered the unknown cause of death and head discomfort to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: This case was reported by the consumer via interactive digital media. The reporter reported that his/her brother in law received a dose of Shingles vaccine and he died a few months later and complained ever since he got it. The reporter said that the patient was never the same. The reporter said that from patient's neighbors had to pick him up off the ground and took the patient inside and hit his head repeatedly. Additional Supportive Information: The follow-up would not possible as no contact details were available. Note: Suspect captured as per narrative as Shingles vaccine conservatively.; Reported Cause(s) of Death: Unknown cause of death
Tingling/numbness on left side of body, extreme pain at area surrounding injection site, difficulty moving left side extremities.
Patient received Afluria flu shot, about 1 & 1/2 to 2 weeks post flu shot experienced lots of heaviness, sore to touch, and radiating pain from elbow down to hand. Patient did report over the last week that it seemed to be getting better. C technique/3 finger estimation was used when administered to determine location of deltoid at time of administration.
Intractable vomiting (12 episodes in 24 hours) with dizzyness, throat swelling, chills, headache. Took Zofran/benadryl with mild relief. Went to ED on 12/26/2020 and had IV fluids and Zofran. Improved and discharged. Symptoms slowly resolving with no longer vomiting and no dizzyness.
Received ZOSTAVAX accidentally instead of VARIVAX. Noted error on 2/21/13. Per mom, T 100 range on 2/21/13 & complaints of arm pain after vaccines given. 2/23/13 erythema & tenderness at site only 1 x 2 cm.
Started to itch one hour after she received vaccine. Took BENADRYL 25 mg - itching better.
pericarditis; Pleurisy; This case was reported by a consumer and described the occurrence of pericarditis in a 54-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th April 2021, the patient received the 2nd dose of Shingles vaccine. In April 2021, less than a week after receiving Shingles vaccine, the patient experienced pericarditis (serious criteria GSK medically significant) and pleurisy. On an unknown date, the outcome of the pericarditis and pleurisy were unknown.   It was unknown if the reporter considered the pericarditis and pleurisy to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself. The age at vaccination was not reported, but the patient could be 54 or 53 years at the time of vaccination. The patient stated she was healthy. She received her shingles vaccine last week from the time of reporting and developed pleurisy and pericarditis 3-4 days later.
03/18/2003 @ 07:00:  Woke up complained of swelling and soreness in left arm at site of injection - advised to apply cold compresses x24hrs - then warm compresses - Tylenol prescribed for pain.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, 7 months later of being vaccinated with a first dose of ZOSTAVAX, the patient was vaccinated with a second dose of ZOSTAVAX, (dose, route, lot number and expiration date not reported). No adverse effects reported. Additional information has been requested.
Fever 102 less than 8hrs after shots given, shortness of breath, rash on trunk, congested lungs.  Parent took child to ER and was diagnosed by ER physician as having an "asthmatic reaction and viral infection."  Three breathing treatments were given in ER, strep throat culture was done but was negative.  Sent home on every hour hour breathing treatments.
The patient has pain in her left arm which developed about one week following the Flu shot. The patient did not receive vaccine last year, but previously vaccinated.
Post vax, the pt complained of diarrhea, fatigue, malaise, decreased energy and motivation, and lack of desire to do anything.
Left shoulder is in a state of very limited movement and almost constant, acute pain. NSAID'S, heat, cold and physical therapy have not helped or relieved the pain.
A breakthrough infection; Started experiencing mild symptoms similar to allergies; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Started experiencing mild symptoms similar to allergies) and INFECTION in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced HYPERSENSITIVITY (Started experiencing mild symptoms similar to allergies). On an unknown date, the patient experienced INFECTION. At the time of the report, HYPERSENSITIVITY (Started experiencing mild symptoms similar to allergies) and INFECTION outcome was unknown.            Test was reported to be scheduled on Friday.  No Concomitant use were reported. No Treatment was reported.
I had no symptoms for the first 48 hours. On days 3-6 I was fatigued but not enough to effect daily living activities.  Day 6 ( Feb 18, 2021) I started to have a lot of muscular aches and the injection site started to get red and swollen.  I had fever and chills from the 18th through the 20th  as well as a swollen arm and a lot of redness in the arm and minor itching. The red area on my arm was a patch about 4 inches wide and 6 inches long. The swelling was confined to the injection site and was raised up in a circle about 2 inches in diameter. My fever during this time was at 99 degrees.  Today is Feb 22 and most of my symptoms are gone, just minor redness and itching at injection site. I was just surprised that my symptoms didn?t show up until about 6 days after the vaccination.. Everything I have read suggested they could appear within 48 hours of the injection.
Initial report received from a healthcare professional on 08 October 2013.  The female patient had received unstable FLUZONE and ADACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
muscle weakness; fever; oxygen level of less than 90; blurred vision; his legs are still kind of weak; his arm still aches on the left side where he got the shot; slurred speech; had no balance; frozen fingers; had no strength in his legs or arms; hallucinations; This is a spontaneous report from a contactable consumer (patient) received via Medical Information Team.  An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm left in Jan2021 at single dose for COVID-19 immunization. The patient medical history included a minor hearing impairment from an unknown date and ongoing. The patient's concomitant medication included vitamin C from Jan2021 and ongoing. On 20Jan2021, the patient experienced hallucinations (the first day or two), slurred speech, he had had no balance, frozen fingers (2 fingers on each hand and his thumb), he had no strength in his legs or arms. On an unspecified date also experienced blurred vision, slurred speech, muscle weakness, fever, oxygen level of less than 90, his arm still aches on the left side where he got the shot. The patient outcome of hallucinations, slurred speech, frozen fingers was recovered, the outcome of he had no balance, he had no strength in his legs or arms was recovering, the outcome of his legs are still kind of weak and his arm still aches on the left side where he got the shot was not recovered, the outcome of the other events was unknown.  Information on the lot/batch number has been requested.
2/6/07 pt awoke feeling achy and fatigued. Mother reports fever of 99 degrees.  Home from school for 2 days.  Illness resolved.
Information has been received from a Registered Nurse referring to a 4 month old female patient. On 23-FEB-2016 at 12:35, the patient was orally (inappropriate route of vaccination) vaccinated with improperly stored (Temperature: 32F - Time frame: 5 minutes) dose of RECOMBIVAX HB (second dose, lot # reported as L013202, dose was unknown). No adverse effect was reported. Lot number L013202 has been verified to be a non-valid lot number for RECOMBIVAX HB. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Information has been received from a nurse practitioner concerning a female patient who on 02-NOV-2007 was vaccinated intradermally into the left vulvar surface with a 0.1 dose of PNEUMOVAX 23.  Fifteen minutes after the vaccination was given, the patient developed a red, swollen area, headache as well as systemic symptoms of a scratchy throat and "stuffy nose" and slight ecchymosis.  It was reported that the injection site was black and blue and sore.  The patient was seen in the emergency room and was treated with BENADRYL, prednisone, and ZANTAC.  On 05-NOV-2007, the patient had a follow up visit and was improving, had no swelling, no systemic symptoms but did still have a slight ecchymosis.  Follow up information indicated that it could not be definitively confirmed that the vaccine used was the PNEUMOVAX 23.  The patient had a high suspicion that this was the product.  No further information is available.
Within 5 minutes, I started to feel tingly all over my body, weak then shakey,  light headed then anxiety started to appear, couldn't take a deep breath, little dizzy.  I was able to walk, so I asked to see a Nurse.  I was taken to an area where I was given oxygen and rest.  My blood sugar was taken, per my request, it was (BG 160) I had eaten breakfast that morning.  I rested with oxygen for about 30 minutes, I felt an improvement, so Nurse asked to stand/walk slow...I did and got just a little dizzy, so I sat with oxygen for about another 20-25 minutes and decided to go home.  Nurse checked my oxygen level, she said it was 100% and my heart rate/pulse was 78.  I decided with the agreement of the Nurse, that I was was okay to go home and rest.  Upon arriving at home, I drank some water and rested.  My arm didn't hurt at all, until a few hours later and then for 1 day. I took a nap, when I awoke a had a slight headache, but was feeling much better, not dizzy, light headed and weakness was minimal, as well as shakiness was  minimal. Also,  a little taste at back of throat/sinus area, like a post nasal drip, kind of like when I go to the dentist. I never did take Benadryl. That strange sensation went away within the day.
Patient presented to the ED with complaints of abnormal vaginal bleeding  and abdominal cramping .  Patient had her last normal menses on November 24, ending on the 27th.  On December 1, she started spotting and then had heavier bleeding with  some nausea
Information has been received from a physician concerning a 15 year old female patient who on an unspecified date was vaccinated with her first dose of GARDASIL (lot number not reported). After the vaccination, on an unspecified date the patient fainted and experienced chest pain. Unspecified medical attention was sought. On an unspecified date the patient fully recovered but it was not known if treatment was required. The patient elected  not to complete the GARDASIL series. Additional information has been requested.
This spontaneous report was received from a certified medical assistant and refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX subcutaneous injection for prophylaxis (lot # M025871 with expiration date: 24-MAY-2018 and lot #M038859 with expiration date: 14-SEP-2018; dose and frequency were not reported). No known adverse effects  were reported. Administered doses of VARIVAX underwent temperature excursions prior to being administered. The doses of the vaccine were exposed to a temperature of 6.8° degree Fahrenheit (F) for a time frame of 45 minutes and to 5.9° degree F for a time frame of 30 minutes. There were no previous temperature excursions. A digital data logger was involved. It was unknown how many patients received each of the vaccine lots listed above. Furthermore, no product quality complaint (PQC) was involved. Additional information has been requested.
Administration error, related to, staff LPN's error in reconstituting vaccine, per manufacturer's directions. LPN  adminsteresed, incorrectly reconstituted to at at 1:47pm. Pt was monitored by staff for recommended 15 min, no s/s adverse reaction/anaphylaxis noted; thus, pt was permitted to leave facility, per standard protocal. Staff LPN, identified error, until after pt left facility. Writer made attempts (x5) to notify pt. Facility MD notified, via phone call, 08/30/2021 at 2:18pm, advised to keep attempting to contact pt. Pt returned call at 4:06pm, notified pt of error.Pt denies any s/s complications Writer @4:56pm to ensure pt felt safe, pt had no complaints/concerns/edu on warning signs.
AT HOME STARTED HAVING HIGH FEVER - 104F GAVE HER TYLENOL THEN HAD SEIZURE AND VOMITING. WENT TO ER SEING DOCTOR TODAY FOR CHECKUP 12-13-07
paleness for 1/2 hrs p/last set of shots about 4 hrs p/inject recovered @ home w/o medical intervention;
Chronic migraine headaches, skin inflammation, sudden onset rheumatoid arthritis in my hands. Sore feet.  General body aches
Patient received vaccine and was at second dose information table talking with agent at table. when she suddenly passed out and fell backward to the floor. EMS in house and immediately responded to the patient.. Patient  was responsive , alert and oriented x 3.   exam by EMS did not reveal any acute injury. EMS advised patient should go to hospital for evaluation since she appeared to hit her head on the floor. Patient declined EMS transport, requested a family member transport her to the hospital.  Patient signed Refusal of transport form for EMS. Patient was monitored by EMS until family member arrives to transport to hospital. Spoke with patient today April 16th. Patient stated she was fine , all test at present are negative. Advised patien to contact Health Department if any changes.
2cm warm, red area left thigh at injection site within 24 hrs. Rx-warm compresses 3x daily and Motrin every 6 hrs.
TOOK ONE DOSE OF UNREFRIGERATED VIVOTIF; This spontaneous case report (PVX2019-1714) was received from pharmacist on 01-Jul-2019. It describes a female consumer who "took one dose of unrefrigerated Vivotif", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first two doses of Vivotif that was refrigerated. The second dose was taken on 27-Jun-2019. Then, she left Vivotif unrefrigerated for 48 hours and took the third dose on 29-Jun-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took one dose of unrefrigerated Vivotif" was considered as not applicable.
Initial information received on 17-Dec-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four months old male patient who was given DAPTACEL before they knew the product was invalid due to delay in transit, while he received vaccine DAPTACEL, on 17-Dec-2018. The patient's past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE. It is an potential medication error due to incorrect product storage. (It was reported that DAPTACEL was given before they knew the product was invalid due to delay in transit). It was not reported that if any adverse reaction was experienced or not. 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. List of documents held by sender: none.
No additional AE; Consumer transferred from CRT. Caller wanted to report a misuse AE on VAQTA. Caller stated that on 10/19/2023, her 2 month old son received VAQTA accidentally. The caller stated that her son was supposed to be getting his 2 month vaccines, but that t; Informed the caller that VAQTA is only approved in children 12 months and older as per the PI; This spontaneous report was received from a consumer and refers to a 2-month-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 19-OCT-2023 the patient was vaccinated by accident with first dose of hepatitis a vaccine, inactivated (VAQTA) lot # 1971534 and expiration date 06-OCT-2023, intramuscularly in the right thigh for prophylaxis (exact dose was not provided).  Other suspect therapies included influenza a(h1n1) pdm09 vaccine (INFLUENZA A(H1N1) PDM09 VACCINE) (wrong product administered, product administered to patient of inappropriate age and no adverse event).
No adverse event; they administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date; HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date), WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date) and WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date), WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (they administered the Moderna COVID-19 monovalent vaccine to 7 pediatric patients after the 30 day use by date) and WRONG PRODUCT ADMINISTERED (HCP confirms that the Moderna monovalent vaccine was administered to these patients and not bivalent).    No concomitant medication details was reported.  It was reported that doses were administered to 3 patients on 18-APR-2023, 2 patients on 20-APR-2023, and 2 patients on 25-APR-2023. No adverse reactions have been reported by the patient. Intact carton was used and vial size was 2.5 ml. The vial was initially stored in the refrigerator on 11-MAR-2023 (BUD:10-APR-2023). The vial did not undergo any temperature excursions.  No treatment medication details was reported.  This case contains information for the 6th patient out of 7 infant patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721478 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721478:(Patient no-1)(Master case)
Hep B and TB skin test given 3/21/16 2:30 PM. 2:57 c/o itchiness to left arm. Ice applied. 3:15 c/o tongue swelling. EMS called. BENADRYL administered by EMS. 3:45 took by EMS to hospital. On way to hospital administered epinephrine since voice was changing. In ER for 6 hours. Refer to allergists. Epi prevention given.
Other than mild pain at the injection site on the night of 2/19/21, things were fine until Tuesday, 2/22/21 when my tongue began twitching.  It is now 2/26/21 and it continues to twitch.  I can eat and drink and swallow fine.
Pt presented to the hospital with progressive weakness and the inability to walk. Pt had bilateral and symmetrical weakness, and had decreased deep tendon reflexes. Pt signs and symptoms were felt to be consistent with Guillain-Barre Syndrome and was treated with IVIG.
Pain in left arm started the night of vaccination. Pain started radiating into the chest. Patient tried icing and used ADVIL but pain still persists. Pain is better than Monday night, but is still uncomfortable sore with limited range of motion. No tingling reported.