chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed red blotches anterior base of neck, throat feeling tight. Patient shared has anxiety with receiving vaccines, similar symptoms have happened in the past.
In May 1999, the pt experienced a mild flu-like reaction, fatigue, and vertigo. On approximately 6/9/99, the pt was vaccinated with 2nd dose of vax. The pt again experienced a flu-like reaction along with diarrhea and dizziness. It was noted that the pt passed out for about an hour, the pt's body temperature was lower than normal and he experienced cold sweats. The pt sought unspecified medical treatment.
inadvertently given the regular Fluzone vaccine instead of the Fluzone high dose with no reported adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves Elderly and unknown gender patient who was inadvertently given the regular quadrivalent influenza vaccine [Fluzone] instead of the influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect quadrivalent influenza vaccine (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization) and inadvertently given the regular fluzone vaccine to a senior citizen instead of the fluzone high dose with no reported adverse event (wrong product administered) (Latency: same day). The information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
When making the appointment for patient in question I spoke with a translator who confirmed with me the children that she was making an appointment for were 12 or older. Before I administered vaccine I asked the patient for her DOB but she was so nervous about the vaccine that she only gave me the month and the day but couldn't remember the year.  Since I had previously confirmed with the translator that the child was at least 12 (who was unable to make it to the appointment) I went ahead and administered the vaccine. After I administered the vaccine the child told me that her birthday was not as reported.
Patient came to Pharmacy to get his Covid-19 Vaccination, but he did not mention that he already had 2 doses at the Health Department, possibly due to confusion/forgetfulness. Patient received a 3rd dose at the pharmacy, when only 2 doses are currently indicated. Patient reports no negative side effects or concerns as of 07/27/21.
Within 24 hours, pt developed an injection site reaction characterized by 3 red, raised streaks near the injection site and discomfort that extended down her arm and into her hand. The discomfort lasted 3 days.
She had a slight sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had a slight sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (She had a slight sore arm). In February 2021, PAIN IN EXTREMITY (She had a slight sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MOD-2021-433634.
Information has been received from a nurse concerning a patient who on an unspecified date was vaccinated with a dose of ROTATEQ (Lot #, expire date and route not reported). Suspect therapy included ROTARIX. Nurse stated that she was confused by an immunization report and confused ROTATEQ with ROTARIX and thought ROTATEQ was only a two dose series. No adverse effect was reported. Additional information has been requested.
swollen lips and internal stomach pain as what happens to me when i eat shellfish and i don?t take medicine prior. itchy skin, hives in anus area
Diarrhea - Left Arm Heavy/Hot/Sore could not move - Pounding Headache - Brain Fog - Off balance/Dizzy
He started to run a fever on 10/24/19 of 100.9 at 4pm. He did not eat and went to bed a few hours later with a temp of 101.5. He woke up at 4am not able to sleep still running a fever of 102.2. He complained his feet hurt. I took him to abovementioned Dr's Office on 10/25/19. They did an exam and stated it was just a virus. Took him home, alternating Tylenol and Motrin every 4 hours and his temp was not responding to the fever reducer. He continued to have a 102.9 temperature. He woke up at 4am on 10/26/19 screaming and crying saying his head hurt and his feet hurt. We noticed his lip was swollen 3x's the normal size. His lips where bright red and chapped. Both feet were swollen and with red blotches and even bruising on both ankles and toes. I took him to the abovementioned Dr's office Urgent care on 10/26/19 the practicing Dr examed him and diagnosed with Kawasaki's Disease. He called Dr. who was at Medical Center and he agreed his sypmtoms were consistent with Kawasaki's Disease. He also had a strawberry tongue, his hands and wrist were swollen and bruised looking, as well as swollen lymph nodes. He sent us immediately to Hospital to be admitted to PEdiatric ICU for Kawasaki's Disease. He had a treamtment of IVIG for 14hrs and his temperature broke that evening at 1am.  They kept us for 48hrs and on Monday 10/28/19 at 5pm he spiked another temperature of 102.2. They gave another dose of the IVIG treatment. He did not have another fever after the treatment on 10/29/19. He was discharged on 10/31/19. We spent 5 nights/ 6 days in the Hospital.  He continues to be fatigue quickly and not normal, as well as complaines his feet can still hurt at times. He will follow up with a cardiologist on 11/14 for hit 3 echocardigram and then will continue to have follow up appointments with a cardiologist.
Swelling, redness, pain and fever 24 hours post inj. No treatment given. Referred to physician for evaluation (his PCP).
facility administeredthe vaccine that was left out on the fridge on Friday and they accidentally administered it to two patients on Saturday; facility administeredthe vaccine that was left out on the fridge on Friday and they accidentally administered it to two patients on Saturday; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID: (004756).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "facility administeredthe vaccine that was left out on the fridge on Friday and they accidentally administered it to two patients on Saturday".  Additional information: Caller is a Pharmacist and one of the pharmacists on the facility administered the vaccine that was left out on the fridge on Friday and they accidentally administered it to two patients on Saturday. Caller would like to know how to handle this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It was reported to this writer by the nurse that the guest stated that she was experiencing new onset of numbness to her left arm. No additional symptoms. Guest  refused water/juice. Guest left after 15 minutes. No additional report of continuing concerns.
Numbness of tongue. Nausea. 12/07/09 Prenatal records received for DOS 10/19/09-11/30/09.   On 11/17/09  pt. reported per telephone call numb tongue, lips and nose. Had vaccinations day before. Advised to treat with benadryl. EDC: 02/09/10.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 9:07 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:20 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.44 for dose administered on 27-Feb-2021 and 70.52 for dose administered on 27-Mar-2021. No concomitant medications were reported. Batch number 019B21A underwent temperature excursion on 27-Mar-2021 with temperature 35 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Batch number 014M20A underwent temperature excursion on 27-Feb-2021 with temperature 35 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.
10JUL pt had welt on area of shot;21JUL broke out on arms & legs;no fever but itching;went to MD & said last reaction to shot;pt had silver dollar since welt;4 welts on each legs, 3 welts on each arm & 5 on neck area;rash not showing p/1wk;
We had a temperature excursion and it was given to one patient; We had a temperature excursion and it was given to one patient; Case reference number US-BN-2022-004313 is a spontaneous case report initially received on 25-Oct-2022 from other healthcare professional (reference number: USBAV22-1773) and concerns a patient of unknown gender and age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: Unknown), at unknown dose, administered via an unspecified route, in unknown anatomical location, for unknown indication.  As reported, the vaccine reached 35.2 degrees Fahrenheit for 1 minute and 35 seconds. It was given to one patient (explicitly coded as 'Product administration error' and 'Product temperature excursion issue').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received on 25-Oct-2022 from Bavarian Nordic included local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from an HCP on 26-Oct-2022 (reference number: USBAV22-1793): new information included* lot number: FDP00005 and information that eight vials involved, given one vial to one patient. *; Reporter's Comments: A patient of unknown gender or age was vaccinated with a dose of Jynneos vaccine on an unspecified date, dose reported as unknown, administered via unspecified route or site. Reportedly, the vaccine was exposed to temperature excursion of 35.2 degrees Fahrenheit for 1 min and 35 seconds and then administered to one patient, which is coded as product administration error and product temperature excursion issue. Both events are listed per company. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse event due to Jynneos vaccination. Product administration error and product temperature excursion issue are assessed as not related to the suspect vaccine but related to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown gender or age was vaccinated with a dose of Jynneos vaccine on an unspecified date, dose reported as unknown, administered via unspecified route or site. Reportedly, the vaccine was exposed to temperature excursion of 35.2 degrees Fahrenheit for 1 min and 35 seconds and then administered to one patient, which is coded as product administration error and product temperature excursion issue. Both events are listed per company convention. The patient's medical history and concomitant medication details were not provided. It was unknown if the patient experienced any adverse event due to Jynneos vaccination. Product administration error and product temperature excursion issue are assessed as not related to the suspect vaccine but related to a human factor. The case is non-serious.
Numbness on arms legs and left side  face with  pain tight cheat  and irregular heart  beat.
Systemic: Seizure-Medium, Additional Details: Patient called on 11/25/21 and talked to the Pharmacist on duty. Patient stated that she had a seizure 45 minutes after the covid shot. She also stated that she normally gets a seizure after an immunization, so it wasn't the first time happening. She was ok then, but will follow up with Neurologist.
Information has been received from a pharmacist referring to a 5 year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was inadvertently administered two extra doses of RECOMBIVAX HB after the three dose series had already been completed. No adverse effects reported. Additional information has been requested.
Nearly 48 hours after I received the vaccine, hives erupted on first my left arm and then my right. Over the past week they have continued to spread about 50% of my body. After six days it continues to worsen.
This spontaneous case reported by a consumer, describes the occurrence of tinnitus in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced tinnitus. At the time of the report, tinnitus outcome: unknown. No concomitant medications or treatment information reported. The patient developed mild tinnitus after getting the second shot.
Left side facial weakness 3 days after shot. Same event after 1st Anthrax. Physical exam C/W Bell's Palsy. Rx Prednisone, eye patch and lacrilube. Follow up states: Pt also had a Bells' Palsy after a previous Anthrax vaccination which resolved after 2 1/2 weeks.
Arthus rxn 6cm in diameter red tender wheal; improved p/3 days rt hip;
I had acute onset Mononeuropathy of the R posterior interosseous nerve; This is a spontaneous report from a contactable physician (patient herself). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) intramuscular on 07Jan2021 at 16:30, at a single dose, for COVID-19 immunization. The patient has no relevant medical history, has no known allergies, and has no concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient previously received first dose of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK5730; expiry date: unknown) on 17Dec2020 at 12:00, for COVID-19 immunization. The patient stated that 48 hours after administration, on 09Jan2021 at 15:00, she had an acute onset mononeuropathy of the right (R) posterior interosseous nerve. Patient stated this may be unrelated and she wanted to know if this is a trend. She was seen by neuro, she had electromyogram (EMG) and magnetic resonance imaging (MRI) and it was definitely an isolated nerve. The event was treated with prednisone. Outcome of the event was recovering. The patient has not been tested for COVID-19 since vaccination.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of mononeuropathy.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report as received from a 90 years old female patient with breast cancer, gallbladder disease and allergy to red Iron Oxide. The patient was vaccinated with dose 1 ZOSTAVAX (lot# was unknown)in approximately June 2012 (reported as about a month ago), A week after received ZOSTAVAX. There was no concomitant therapy, the patient experienced chickenpox, It went away than a week later it came back. The patient sought medical attention, doctor give her a cream which help with the extension of the chickenpox, The outcome of chickenpox was unknown. Additional information is not expected.
Has signs of myocarditis with pain near her heart and a pressure in her chest with breathing that feels a bit labored with deep breaths, but she isn't experiencing difficulty breathing. She complained of the symptoms on Thursday morning and then we saw on the news that night that this was a newly discovered side effect for younger patients receiving the vaccine. She has not met with the doctor yet because she didn't want to miss final tests at school and the offices were closed for the weekend.  However, we have been monitoring her closely and had hoped it would disappear by now, but we will be seeking treatment tomorrow since it has not gotten worse, but it also hasn't improved after 4 days of rest.
brief lip and tongue numbness, no swelling or SOB.  Monitored 30 minutes.
DIAGNOSED WITH COVID 1/15/2022 - NASAL CONGESTION, COUGH, SORE THROAT, JANSSEN ON 04/07/2021
This is a spontaneous report from a physician received via a Pfizer sales representative. A 16-year-old male patient received TRUMENBA, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that arm on fire and flu like symptoms, body aches for 2-3 days. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Client states that at 4 days (Friday) after receiving 2 shots and DEPO, she noticed a rash in the "crease" of both arms and legs, and chest. C/o itching at the rash sites. No treatment. States will get "cream" & BENADRYL.
On the evening of the 8th day after my first dose of the Moderna COVID-19 vaccine, I noticed an oval patch of what appeared to be a red rash in the area surrounding and below the injection site. There was no pain or itching associated with the rash but it persisted for a couple of days. After I found some reference to such a vaccine side-effect on-line, I contacted my physician who advised use of an OTC topical cortizone cream. I followed his instructions and after about 5 days the redness subsided and the rash disappeared.
Sore arm and Fever 100-101 since immunization administered, has not taken any medication for fever. Advised to take Tylenol and call MD.
The pt experienced hives, spots on chin within 3-4 minutes of vax. The pt complained of stiffness on left side  beginning 1/2 hour post vax for 30 minutes.
less fever; chills; shoulder pain; arm pain; swollen lymph node; painful lymph node; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th October 2021, the patient received Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced fever, chills, shoulder pain, pain in arm, enlargement of lymph nodes and lymph node pain. On an unknown date, the outcome of the fever, chills, shoulder pain, pain in arm, enlargement of lymph nodes and lymph node pain were unknown.   It was unknown if the reporter considered the fever, chills, shoulder pain, pain in arm, enlargement of lymph nodes and lymph node pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingrix vaccine on Monday before reporting date. The patient had all the symptoms above less fever (but chills). Moreover, the patient had developed a swollen, painful lymph node above clavicle certainly arm and shoulder pain. The patient enquired if he or she was ok. The follow-up would not possible as no contact details were available.