chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received dose about 2 weeks too soon; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received dose about 2 weeks too soon) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (The first dose was given on 25-May-2021 and the second dose was given on 15-Jun-2021.) from 25-May-2021 to 15-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received dose about 2 weeks too soon). On 03-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received dose about 2 weeks too soon) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-406059 (Patient Link).
Patient developed a rash and proceeded to ER where he was treated and sent home. Patient returned home and then had some difficulty breathing so returned to the hospital where is was admitted for treatment and observation.
A health and safety specialist reported that a female patient (age, race and ethnicity not provided) received the first and second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization three weeks apart instead of one month apart. No relevant medical history was reported. No relevant concomitant medications were reported. On 22-May-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unknown route and site. On 13-Jun-2021, 23 days (3 weeks) after having been vaccinated with the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in an unknown route and site. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Fetal death. At time of vaccination with first booster patient was five and a half months pregnant. She described that a few days after vaccination saw her obstetrician and apparently the baby was moving less. On 1/3/2022 at 22 weeks gestation ultrasound showed intrauterine fetal death. Admitted to Hospital and suction D&C done 5/5/2022.  Past history miscarriage 2006, 2016, 2017 and missed abortion 8 weeks gestation 5/4/2021. Birth of twins by C-section 2017.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 24-MAY-2016 the patient was vaccinated with a dose of VARIVAX (lot # L042266, expiration date: 27-OCT-2017, dose was unknown) which was improperly stored (42.3 Fahrenheit (F) for 2 hours 15 minutes). No adverse events were reported. Previous temperature was not excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, right deltoid swelling, hot to touch and redness. High fevers of 102.0-103.0F  Patient reports having high fevers, headache and nausea. Presented to ED with the mentioned symptoms.  Swelling approx. size of softball.
Patient was 11 years and 9 months old when she received the Covid Pfizer Bivalent , gray cap, for ages 12 and up.  No immediate adverse outcomes noted. Team Supervisor left voicemail notifying parent and requesting follow up phone call.  No return call by parent.  Attempted to reach out again via phone but no return call by parent. Parent did not leave any email address on consent form.
Erythema and pain with raised edema localized reaction. 2x1 inch in size, normal puerperal Purpura and normal range of motion.
Patient's mother stated that her son developed some red bumps on left shoulder and neck.  Patient was given 2.5 mL of Diphenhydramine. Patient was observed for 30 minutes after administration of medication. Patient did not experience any swelling or difficulty breathing before being discharged of clinic.
Information has been received from a 22 year old female consumer who on 29-APR-2010 was vaccinated with a dose of GARDASIL injection (dose and lot number not reported). On 29-APR-2010, the patient stated that she experienced pain in her arm, neck and chest; she was also unable to lift her arm. At the time of reporting, the patient had not recovered from pain in her arm, neck, chest and unable to lift her arm. The patient did not seek for medical attention. No further information is available.
AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY PAINFUL. SAW MY PA ON 03/25/21. VALTREX PRESCRIBED. BLISTERS WERE MUCH BETTER WITHIN 48HOURS. 03/27/21 UNEXPECTEDLY HAD MY PERIOD. I HAD JUST FINISHED UP MY PERIOD WHEN I HAD THE VACCINE ON 03/18/21. THIS PERIOD WAS UNLIKE ANY OTHER. THE BLEEDING WAS INCREDIBLY HEAVY, FULL OF CLOTS AND LASTED 9 DAYS. MY USUAL CYCLE IS 5.  AFTER SECOND DOSE: ANOTHER UNEXPECTED PERIOD. THIS TIME NOT AS HEAVY, NOT AS MANY CLOTS AND DID NOT LAST AS LONG.  SORE UNDERNEATH ARM AND LYMPH NODE UNDER ARM SWELLED.
5 cm flare, headache, neck pain without nuchal rigidity, nausea, malaise.    Advised to take acetaminophen as directed on package for symptoms.  To see physician if symptoms persist or worsen.
About 12 hours later after the injection, there was fever over 100F, body aches and shaking (chills) and took Tylenol of 750 mg. Then about 4am had a severe headache, body aches and dehydration ,and took tylenol of 500 mg. Today april 21st at 9am the fever rised and headache continues, took ibuprofen of 600mg.
bad strep throat; got a really bad high blood pressure for 3 weeks; kidney was hurting; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number EL3247, Expiration date: May2021) via an unspecified route of administration in Arm Left on 02Mar2021 (at the age of 69-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included she was sensitive to chemicals, but did not specify any from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for blood pressure abnormal from an unknown start date. On 05Mar2021, the patient got a really bad high blood pressure for 3 weeks, kidney was hurting and bad strep throat on an unspecified date. She was scared to get the 2nd shot. She had bad strep throat when it came to get the second vaccine. She didn't get her second dose. She asked what do I do to become fully vaccinated and if it was too late to get the second shot. Can I switch over to Moderna. Description of complaint included, she got the Pfizer COVID shot on 02Mar2021. After the shot she had high blood pressure and her kidneys hurt for 3.5 weeks. This high blood pressure and kidney pain started 3 days after the shot on 05Mar2021. She was afraid she was going to have a stroke because her blood pressure medicine wouldn't bring down her blood pressure. She was on Lisinopril. She didn't have the NDC/lot/expiration for the Lisinopril. The doctor increased the mg from 20mg to 40mg. She was back on 20 mg now. After the 3.5 weeks, it just stopped. Her kidneys and her blood pressure went back to normal. She got her urine tested and it was fine. The patient underwent lab tests and procedures which included blood pressure measurement: normal on After the 3.5 weeks, it just stopped. Her kidneys and her blood pressure went back to normal, blood pressure measurement: high on 05Mar2021, urine analysis: fine on an unknown date. The outcome of the events was recovered and bad strep throat was unknown.  Follow-up attempts are completed. No further information is expected.
had two doses of moderna  #1 01-08-21 #2  01/29/2021. tested positive for covid 02-25-2021 and also 03/01/2021
This is a spontaneous report from a Pfizer-sponsored program received from a contactable physician. A 78-year-old female patient of unspecified race/ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) (unspecified trade name), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergy to pneumococcal 13-val conj vac (dipht crm197 protein) and hives both on an unspecified date with outcome of unknown. No follow-up attempts needed. No further information expected.
Pt COVID + on 10/29/2021.  Admitted with syncope, fall, fever, altered mental status changes and COVID-19. Treatment:  IV decadron, Breo inhaler, albuterol nebulizer. Family took patient home.
headache left temple, sinus pain & pressure, eye strain, sensitive to light, pain in left neck left shoulder and left deltoid at injection site. Dizzy, lethargic, overall full body weakness & tired, constantly sleepy, barely enough energy to walk to bathroom from couch or kitchen,  almost constant nausea, upset stomach, mild diarrhea, lack of appetite, alternate between cold chills to warm flushed sweaty & nausea. Involuntary muscle spasms full body during cold chills dispite wearing 2 sweat shirts, a jacket, electric heat blanket, 2 blankets and sweat pants. Mild back pain in right lumbar area.
vaccination dose on 3-26-2021. Patient reports less joint pain; This is a spontaneous report received from other health care professional (clinician). This Other Health care professional reported for a 64-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown, Expiry date: unknown), via an unspecified route of administration on 26Mar2021 at a single dose for COVID-19 immunization. Patient's physician had put Xeljanz on hold since 11Apr2021, due to elevated cholesterol, blood pressure, HA's. Patient reported less joint pain since off of Xeljanz, but she cannot be sure if her COVID vaccine had anything to do with her present s/e's.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received the vaccination on Friday afternoon (10/26/18). By the following morning she noticed the injection site was starting to itch. The injection site continued to get red and itchy throughout the day and has continued through Sunday morning. She came into the pharmacy to ask about the reaction on Sunday 10/28/18. The injection site was red and circular in appearance. She stated it was still itchy, but is less itchy than it was earlier. The patient states that the injection site reaction appears to be less inflamed and red than it was in the morning.
His breathing problem worsened on 02/23/2021, short of breath and tired. He died of a pulmonary embolism and heart attack in the hospital on 3/9/21 after being there for 9 days.
Information has been received from a nurse practitioner concerning an 11-year-old female with no pertinent medical history or allergies, who on 21-May-2007 was vaccinated subcutaneously with a second 0.5 milliliters dose of varicella virus vaccine live (Oka/Merck) (lot# 656576/0446U). There was no concomitant medication. The nurse practitioner reported that on 23-May-2007 the patient experienced pain and swelling at the injection site. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. Subsequently, the patient recovered from the swelling and pain at injection site. No product quality complaint was involved. Additional information has been requested.
Pt has rash & itching (L) arm 5 1/2 cm x 3 cm reddened & swollen area around injection site - hurts under (L) arm - instructed pt to go PMD or ER.
Information has been received from a physician concerning a 12 month old female with no known allergies and a history of cellulitis in left leg at 6 months old following a vaccination with the third dose of PEDIARIX who on 23-APR-2008 was vaccinated into the left leg with first dose of VARIVAX (Merck) (Lot # 632727/0089K). Vaccines received on the same day included MMR (MSD) and PREVNAR. About a week later, on approximately 04-MAY-2008 the patient developed 2x2 cm raised irregular form mass at injection site. There was no fever, no tenderness, and no illness at the time of vaccination. (Previous reaction in that leg to another vaccine was more severe). On an unspecified date the patient recovered. Additional information is not expected.
Simple spasms on shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Simple spasms on shoulder) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 034C21A) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant (surgery done 10 years ago). Concomitant products included INSULIN and METFORMIN for Diabetes.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Simple spasms on shoulder). At the time of the report, MUSCLE SPASMS (Simple spasms on shoulder) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, SARS-CoV-2 antibody test: very little (Low) Result was very little.         Other concomitant medications such as immunosuppressive drugs, Novastic for blood pressure, and an unnamed cholesterol medication.  No treatment information was given by the reporter.   This case was linked to MOD-2021-239394 (Patient Link).
Headache, chills, high fever 103-104 for about 14 hours on Dec 8, 2021. Significantly more severe reaction than after Moderna 1&2 during 1st quarter of 2021. It was shocking. Self treated with rest, gatorade, water. Had family member check on me.
1st 3 doses ok, year later 4th dose missed; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (On an unknown date ,received 1st dose), Twinrix (On an unknown date ,received 2nd dose) and Twinrix (On an unknown date ,received 3rd dose).   On an unknown date, the patient received the 4th dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 19-Jan-2023. Reporter's Comments: Reporter stated that they called to inform that a patient went under the accelerated dosing schedule for Twinrix and received the first three doses as they should be but missed the last one by more than a year. The Vaccine Administration Facility is the same as Primary Reporter. The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting, patient did not received 4th dose of Twinrix which led to incomplete course of vaccination.
Patient is a 39-year-old white female with a PMH of depression, anxiety, migraine and chronic sinusitis.  She has NKDA.  Her medications prior to event included alprazolam 0.25mg Qday, citalopram 20mg, 1 and ½ tabs Qday, Topamax 25mg, 3 tabs Qday and Zyrtec 10mg Qday.  She was administered her first dose of the Pfizer COVID vaccine on 1/21/21 at 1:30pm. She presented to the hospital on 1/22/21 @ 9:45am with acute onset of right sided weakness (she is a teacher who collapsed in her classroom without LOC) and was found to have a intraparenchymal hematoma (IPH) in the left posterior paramedian frontal lobe measuring up to 2.9 x 1.8 x 3.4cm with surrounding vasogenic edema and mild local mass effect with no underlying mass lesion or vascular malformation on MRI.  She stated that she has had intermittent headaches over the last few weeks not similar to her prior migraines, although with no neuro deficits.  She was also noted to have a urine tox screen positive for amphetamines.  There is a confirmatory test pending.  She was discharged to acute rehab on 1/25/21.  Patient is still recovering from the adverse event.  She did not receive any other vaccines within a month prior to the event.
First dose in May2018 and no other doses adminstered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 37-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose in May 2018, batch number NL4J9, expiry date 6th October 2019).   On an unknown date, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient started the Engerix B series and got 1st dose. No other doses administered to the patient till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up via postal and declined to provide email address.
A non-serious spontaneous report of gave H1N1 to children less than two years old was received from a registered nurse/health professional concerning a 14-month-old male. The patient's medical history included sickle cell trait, but no disease and no concomitant medications was taken by the patient. On 29-Oct-2009, the patient received H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 18-Dec-2009 and incorporated into the narrative: The patient's medical history and concomitant medications.
Patient reports having experienced a headache the evening after vaccine administration. This was shot number 2 in her Shingrix series. The patient reported no headache with the first vaccine. The patient does have a history of headaches/migraines, so the patient was unsure if the vaccine triggered the vaccine or not. The patient tried Tylenol Sinus with no relief, so then she tried taking Zomig before bedtime, still with no relief. The next morning, the patient tried taking Fioricet, still with no relief. After trying those three medications, the patient called the pharmacy to report her symptoms and potential reaction. At the time of this submission, the patient has not sought out any additional medical attention.
I started to feel bad like with the flu vaccine within hours of receiving booster shot. As it began to progressively get worse I felt feverish, nauseated, headaches came on, and extreme fatigue. By Sunday I was feverish and very sick again.  I was given an injection of Zofran after the ambulance was called, whom stated that they found nothing wrong with her vitals. On Tuesday I was seen on a video visit, and was told to get tested. I have taken the flu test and covid test that both came back negative. No upcoming appointments.
No problems the remainder of day of injection. Next morning upon awakening, I was very groggy and unable to stay awake. I slept 4 hours past my normal time for getting up. I had no balance and would stagger when standing. My entire body was in muscle and nerve pain. Even my skin hurt. I took 300 mg of Gabapentine which eased my pain. I continued to be off balance the remainder of the day, however, by the end of the day I was much better. I took several 1 hour naps throughout the day.
Initial information received on 29 January 2009 from a health care professional. A female patient with a history of diabetes, asthma, and an allergy to morphine received the influenza vaccine (manufacturer, lot number, route and site not reported) on an unspecified date. The patient developed facial swelling post vaccination. The onset date for facial swelling was not provided. No further information was provided. The patient's recovery status was not reported. List of Documents held by Sender: none. The reporter of this case is the same as case number 2009-00328.
PAIN at the injection site; Injection site bleeding; UNDERDOSE; Inadvertent exposure to vaccine; exposure via skin contact; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd October 2019, immediately after receiving Shingrix, the patient experienced injection site pain, injection site bleeding, underdose, inadvertent exposure to vaccine and exposure via skin contact. The patient was treated with ibuprofen, ibuprofen (Motrin) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain and injection site bleeding were recovered/resolved and the outcome of the underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   It was unknown if the reporter considered the injection site pain and injection site bleeding to be related to Shingrix.  Additional details were provided as follows: The patient reported pain at the injection site when injected and her arm hurt that evening. She treated with motrin and benadryl and the pain resolved by the next day. She also said that after receiving the injection, blood and some liquid dripped down her arm and she was not certain if she received the entire dose.  The injection was given in the upper shoulder area of the deltoid muscle. The reporter did not consent to follow up. The reporter was a nurse and was also the patient.
Information has been received from a nurse concerning an 11 year old female who on an unspecified date was vaccinated with a 0.5 ml first dose of Gardasil.  Concomitant therapy included MENACTRA.  Subsequently, the patient experienced dizziness, nausea, and abdominal pain.  The symptoms lasted for "a day" and the patient recovered.  She did not report the event at the time of the occurrence.  On 29-AUG-2007 she was vaccinated with a second dose of Gardasil.  "The office is trying to follow-up with the patient to see if she had the same experience after the second dose of Gardasil, but no contact has been made yet".  There were no laboratory or diagnostic tests performed.  The patient was seen in the office.  Additional information has been requested.